This study is currently recruiting participants.
Number
001099-C
Sponsoring Institute
National Cancer Institute (NCI)
Recruitment Detail
Type: Participants currently recruited/enrolled Gender: Male & Female Min Age: 18 Years Max Age: N/A
Referral Letter Required
No
Population Exclusion(s)
Neonates;Fetuses;Pregnant Women;Children
Keywords
High Mutational Burden; Tmb-H; Msi-H/Mmr Deficient; Virally Associated Tumors; Merkel Cell Carcinoma
Recruitment Keyword(s)
None
Condition(s)
Tmb-H Cancers; Msi-H/Mmr Deficient Cancers; Merkel Cell Carcinoma; Metastatic Triple Negative Breast Cancer; Relapsed And Refractory Epithelial Ovarian Cancer; mCRPC; Crc; NSCLC; Cervical Cancer; Anal Cancer
Investigational Drug(s)
STAR0602
Investigational Device(s)
Intervention(s)
Drug: STAR0602
Supporting Site
National Cancer Institute
Many current cancer treatments, called immunotherapy, work by enhancing the body s own immune system s ability to attack tumors. Different immunotherapies work in different ways. Yet none of these treatments work equally well against all tumors. New approaches are needed.
Objective:
To test a study drug (STAR0602) in people with advanced solid tumors.
Eligibility:
People aged 18 years and older with an advanced solid tumor, and their current treatment is no longer working.
Design:
Participants will be screened. They will have blood and urine tests and tests of their heart function. Their ability to perform daily tasks will be assessed. They will have imaging scans at screening; these will continue every 2 months during the study. Participants may need to have a biopsy, a small sample of tumor tissue removed, for screening; if they have already had a biopsy, that sample may be used.
Participants will receive the study drug through a tube attached to a needle placed in a vein. They will receive the drug 2 times during a 28-day cycle. Some participants may be required to stay in the hospital for 24 hours after receiving the drug.
Some study visits may occur in the participant s home, with a home health nurse.
Participants may have an additional tumor biopsy during their first treatment cycle.
Participants may continue to receive the study drug for up to 3 years. They will visit the clinic 2 months after their last treatment. Further follow-ups will occur by email or phone every 2 months for at least 12 months.
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INCLUSION CRITERIA: Each subject must also meet all the following criteria to be enrolled in this study: General: - Age >= 18 years old. - Eastern Cooperative Oncology Group (ECOG) performance status of <= 1. - Ability to provide written informed consent prior to initiation of any study-related tests or procedures that are not part of standard of care for the subject s disease. Subjects must also be willing and able to comply with study procedures, including the acquisition of specified research specimens. - Life expectancy >=12 weeks. - Measurable disease as per RECIST v1.1 criteria and documented by CT and/or MRI. Cutaneous or subcutaneous lesions must be measurable by calipers. Lesions to be used as measurable disease for the purpose of response assessment must either: a) not reside in a field that has been subjected to prior radiotherapy; or b) have demonstrated clear evidence of radiographic progression since the completion of prior radiotherapy and prior to study enrollment. Tumor Histology Types - For Phase 1, subjects must have one of the following solid tumors: a. High mutational burden (TMB-H per local institutional testing); Tumor specimen is preferred (>= 10 mut/Mb), but if not available, liquid biopsy is allowed; b. MSI-H/dMMR cancer (per local institutional testing); Tumor specimen is preferred, but if not available, liquid biopsy is allowed; c. Virally associated tumors such as Merkel cell carcinoma, cervical, oropharyngeal, anal, penile, vaginal, and vulvar cancers , or EBV-related solid tumors. No viral testing required for Merkel cell carcinoma, cervical, or anal cancers. For oropharyngeal, penile, vaginal, and vulvar cancers, human papilloma virus (HPV) positivity documented per local institutional testing is required. For EBV-related solid tumors, EBV positivity documented per local institutional testing is required. d. Solid tumors generally considered as immunogenic (e.g., melanoma and renal cell carcinoma) are eligible without prior testing for TMB, MSI or viral status after the Sponsor s approval. - For Phase 2, subjects must have one of the following solid tumors: a.High mutational burden (TMB-H >= 10 mut/Mb per local site testing). Tumor specimen is preferred, but if not available, liquid biopsy is allowed; b. MSI-H/dMMR cancer (per local site testing). Tumor specimen is preferred, but if not available, liquid biopsy is allowed; c. CRC (both Ras wild-type and mutant) TMB-H, or MSI-H/dMMR, or both TMB-H and MSI-H/dMMR as defined above; d. Virally associated tumors such as Merkel cell carcinoma, cervical, oropharyngeal, anal, penile, vaginal, and vulvar cancers, or EBV-related solid tumors. No viral testing required for Merkel cell carcinoma, cervical or anal cancers. For oropharyngeal, penile, vaginal, and vulvar cancers, HPV positivity documented per local institutional testing is required. For EBV-related solid tumors, EBV positivity documented per local institutional testing is required; e. Metastatic triple-negative breast cancer (mTNBC); f. Platinum-resistant epithelial ovarian cancer; g. Metastatic castration-resistant prostate cancer (mCRPC); h. Primary stage IV or recurrent non-small cell lung cancer (NSCLC); i. Solid tumors generally considered as immunogenic (e.g., melanoma and renal cell carcinoma) are eligible without prior testing for TMB, MSI or viral status after the Sponsor s approval. Other histologies may also be included in Phase 2 as additional data emerge to support their inclusion. Tumor Specimen: - Subjects must allow for acquisition of existing formalin-fixed paraffin-embedded archival tumor sample, either a block or unstained slides that had been procured within 3 months prior to enrollment, if available. The subject also must not have received intervening therapy between archival specimen collection and the first dose of STAR0602. - If a study site cannot retrieve such existing archival tumor sample within 2 weeks after the initial attempt, or archival tumor is not available, the following subjects must consent to fresh baseline tumor biopsy during Screening: --Dose Escalation (Phase 1) subjects: only after a dose escalation cohort is identified with clear evidence of STAR0602 biological effect (e.g., expansion of target T cell subsets, anti-tumor effect, or other relevant biomarker assessments), i.e., subjects still enrolling in this dose escalation cohort and at the higher dose levels thereafter; --Backfill subjects (in Dose Escalation): the additional subjects enrolled in Dose Escalation at a dose level deemed below or at the MTD; --Dose Expansion Cohort (Phase 2) subjects. - Above subjects must also consent to a second tumor biopsy 21 days (+/- 3 days) after the first dose administration of STAR0602. Laboratory Features: - Acceptable laboratory parameters as follows: --Albumin >= 3.0 g/dL; --Platelet count >= 75 x 103/micro L; --Hemoglobin >= 8.5 g/dL; --Absolute neutrophil count >= 1.5 x 103/micro L; --ALT/AST <= 3.0 x upper limit of normal (ULN); --Total bilirubin <= 1.5 x ULN, except subjects with Gilbert s syndrome, who may be enrolled if the conjugated bilirubin is within normal limits; --LDH <= 3 x ULN --Calculated creatinine clearance >= 50 mL/min based on Cockcroft-Gault formula Reproductive Features: - Female subjects of childbearing potential (not surgically sterilized and between menarche and 1-year post-menopause) must have a negative serum (screening) or urine pregnancy test performed within 72 hours prior to the initiation of study drug administration. Female subjects of childbearing potential must be willing to use two forms of contraception throughout the study, from the time of consent through 60 days after the last dose of STAR0602. Examples of effective contraception are birth control pills, birth control patch (e.g., Ortho Evra), NuvaRing, intrauterine device, female condom, diaphragm with spermicide, cervical cap, use of a condom by the sexual partner, documented sterile sexual partner or documented evidence of surgical sterilization (e.g., tubal ligation or hysterectomy) at least 6 months prior to Screening. Abstinence is acceptable if this is the established and the preferred contraception method for the subject. It is not necessary to use any other method of contraception when complete abstinence is elected. - Male subjects with partners of childbearing potential must use barrier contraception from the time of consent through 60 days after last dose of STAR0602 and must not donate sperm during this period. In addition, male subjects should also have their partners use contraception (as documented for female subjects) for the same period of time. CNS Metastases: - Symptomatic central nervous system (CNS) metastases must have been treated, be asymptomatic for >= 14 days, and meet the following at the time of enrollment: --No concurrent treatment for CNS disease (e.g., surgery, radiation, corticosteroids > 10 mg prednisone/day or equivalent); --No concurrent leptomeningeal disease or cord compression. Previous Checkpoint Inhibitor Therapy: -Subjects who have previously received a CPI (e.g., anti-PD-L1, anti-PD-1, anti-CTLA-4) prior to enrollment must have CPI immune-related toxicity resolved to either Grade <= 1 or baseline (prior to the CPI) to be eligible for enrollment. --Subjects who experienced previous CPI-related endocrine abnormalities are eligible for the study regardless of CTCAE grade if well controlled on replacement therapy. --Subjects who have had previous CPI-related Grade 3 to 4 pneumonitis, peri/myocarditis, colitis and bowel perforation, myositis, encephalitis, or peripheral neuropathy should be excluded. EXCLUSION CRITERIA: Subjects who meet any of the following criteria will be excluded from the study: - Subjects with a history of known autoimmune disease with exceptions of: --Vitiligo; --Psoriasis, atopic dermatitis, or other autoimmune skin condition not requiring systemic treatment; --History of Graves disease, now euthyroid for > 4 weeks; --Hypothyroidism managed by thyroid replacement; --Alopecia; --Arthritis managed without systemic therapy beyond oral nonsteroidal anti- inflammatory drugs. --Adrenal insufficiency- well controlled on replacement therapy. - Major surgery or traumatic injury within 8 weeks before first dose of study drug. - Unhealed wounds from surgery or injury. - Treatment with >10 mg per day of prednisone (or equivalent) or other immune-suppressive drugs within 7 days prior to the initiation of study drug. Exceptions may be made for patients who have had allergic reaction to iodinated contrast media. Steroids for topical, ophthalmic, inhaled, or nasal administration are allowed. - Prior therapy within the following timeframe before the planned infusion of STAR0602 as follows: --Cytotoxic chemotherapy, small molecule inhibitors, radiation, interventional radiology procedure, or similar investigational therapies within <= 2 weeks or subjects who have not recovered (i.e., <= Grade 1 or to baseline) from AEs due to a previously administered agent; --Monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, or similar investigational therapies within 6 weeks prior to the initiation of study drug or subjects who have not recovered (i.e., <= Grade 1 or to baseline) from AEs due to agents administered more than 6 weeks earlier. Note: Subjects with <=Grade 2 neuropathy or <= Grade 2 alopecia are an exception to this criterion and may qualify for the study. Note: Concurrent use of hormones either to maintain castrate levels of testosterone in subjects with castration-sensitive prostate cancer or for non-cancer-related conditions (e.g., insulin for diabetes, hormone replacement therapy) is acceptable. Bisphosphonates are permitted for supportive care of bone metastases (e.g., breast or prostate cancer). - Clinically significant cardiovascular/vascular disease including: --Myocardial infarction or unstable angina < 6 months prior to the initiation of study drug; --Clinically significant cardiac arrhythmia (e.g., with potential for hemodynamic instability) not controlled or unresponsive to treatment; --Uncontrolled hypertension: systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg; Subjects with systolic blood pressure > 140 mmHg but < 180 mmHg and/or diastolic blood pressure > 90 mmHg but < 100 mmHg may be enrolled upon reviewing co-morbidities/risks and after the sponsor approval. These subjects need to be closely monitored with their blood pressure assessed and managed at each visit on treatment; --Pulmonary embolism, stroke, or transient ischemic attack < 6 months prior to initiation of STAR0602; --QTcF (Fridericia correction) prolongation > 480 msec; --Congestive heart failure (New York Heart Association Class III-IV); --Pericarditis/clinically significant pericardial effusion; --Myocarditis; --Vasculitis that has not resolved within 6 months prior to study drug. - Clinically significant gastrointestinal disorders including: --Gastrointestinal perforation < 6 months prior to study drug administration. Subjects must have documented evidence (e.g., upper endoscopy, colonoscopy) of completely healed area of prior perforation; --Gastrointestinal bleeding < 2 months prior to study drug administration. Subjects must have documented evidence (e.g., upper endoscopy, colonoscopy) of completely healed area of prior bleeding; --Pancreatitis <6 months prior to the initiation of study drug. Subjects must have a CT scan negative for evidence of remaining disease or normal pancreatic enzyme levels for > 4 weeks prior to the initiation of study drug; --Diverticulitis flare < 2 months prior to study drug administration. Subjects must have a CT scan negative for evidence of remaining disease prior to the initiation of study drug; --History of Crohn s disease or ulcerative colitis. - Inflammatory process that has not resolved for >= 4 weeks from the date of first study dose. Subjects with chronic low-grade inflammatory processes such as radiation-induced pneumonitis are excluded regardless of duration. - Clinically significant pulmonary compromise (e.g., requirement for supplemental oxygen on a continuous basis). - Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days prior to the initiation of study drug. Systemic antiviral, antifungal, or antibacterial therapy must be completed > 1 week prior to the initiation of study drug. Antimicrobial prophylaxis (e.g., for pneumocystis carinii infection) may continue the antimicrobial for that purpose. - Vaccination with any live virus vaccine within 4 weeks prior to the initiation of study drug administration. Inactivated annual influenza vaccination is allowed. - Subjects who are known to be human immunodeficiency virus (HIV) positive or hepatitis B or C positive and have uncontrolled disease. Subjects treated for hepatitis C must have viral titers below the limit of quantification to be eligible. Subjects with hepatitis B having undetectable or <= 500 IU/mL hepatitis B viral DNA are eligible for STAR0602. Subjects treated for HIV must have CD4+ T cell (CD4+) counts >= 350 cells/micro L and HIV viral load less than 400 copies/mL to be eligible. - Second primary invasive malignancy not in remission for >= 1 year. Exceptions include non-melanoma locally advanced skin cancer, cervical carcinoma in situ, localized prostate cancer (Gleason score <= 7), resected melanoma in situ, or any malignancy considered to be indolent and never required systemic therapy, with the exception of indolent lymphomas. -Any serious underlying medical or psychiatric condition that would preclude understanding and rendering of informed consent or impair the ability of the subject to receive or tolerate the planned treatment. -Known hypersensitivity to STAR0602 or any excipient (histidine or polysorbate-80) contained in the drug or diluent formulation. -Any medical (e.g., requirement of an indwelling catheter such as PleurX or Tenckhoff catheter) or non-medical issue that would contraindicate the subject s participation in the study or confound the results of the study. -Pregnant, likely to become pregnant, or lactating women (where pregnancy is defined as the state of a female after conception and until the termination of gestation). -Hepatic metastases unless adequately treated, either locally (e.g., by surgery, radiofrequency ablation, or chemoembolization) or systemically or both, and stable for 3 months.
Each subject must also meet all the following criteria to be enrolled in this study:
General:
- Age >= 18 years old.
- Eastern Cooperative Oncology Group (ECOG) performance status of <= 1.
- Ability to provide written informed consent prior to initiation of any study-related tests or procedures that are not part of standard of care for the subject s disease. Subjects must also be willing and able to comply with study procedures, including the acquisition of specified research specimens.
- Life expectancy >=12 weeks.
- Measurable disease as per RECIST v1.1 criteria and documented by CT and/or MRI. Cutaneous or subcutaneous lesions must be measurable by calipers. Lesions to be used as measurable disease for the purpose of response assessment must either: a) not reside in a field that has been subjected to prior radiotherapy; or b) have demonstrated clear evidence of radiographic progression since the completion of prior radiotherapy and prior to study enrollment.
Tumor Histology Types
- For Phase 1, subjects must have one of the following solid tumors:
a. High mutational burden (TMB-H per local institutional testing); Tumor specimen is preferred (>= 10 mut/Mb), but if not available, liquid biopsy is allowed;
b. MSI-H/dMMR cancer (per local institutional testing); Tumor specimen is preferred, but if not available, liquid biopsy is allowed;
c. Virally associated tumors such as Merkel cell carcinoma, cervical, oropharyngeal, anal, penile, vaginal, and vulvar cancers , or EBV-related solid tumors. No viral testing required for Merkel cell carcinoma, cervical, or anal cancers. For oropharyngeal, penile, vaginal, and vulvar cancers, human papilloma virus (HPV) positivity documented per local institutional testing is required. For EBV-related solid tumors, EBV positivity documented per local institutional testing is required.
d. Solid tumors generally considered as immunogenic (e.g., melanoma and renal cell carcinoma) are eligible without prior testing for TMB, MSI or viral status after the Sponsor s approval.
- For Phase 2, subjects must have one of the following solid tumors:
a.High mutational burden (TMB-H >= 10 mut/Mb per local site testing). Tumor specimen is preferred, but if not available, liquid biopsy is allowed;
b. MSI-H/dMMR cancer (per local site testing). Tumor specimen is preferred, but if not available, liquid biopsy is allowed;
c. CRC (both Ras wild-type and mutant) TMB-H, or MSI-H/dMMR, or both TMB-H and MSI-H/dMMR as defined above;
d. Virally associated tumors such as Merkel cell carcinoma, cervical, oropharyngeal, anal, penile, vaginal, and vulvar cancers, or EBV-related solid tumors. No viral testing required for Merkel cell carcinoma, cervical or anal cancers. For oropharyngeal, penile, vaginal, and vulvar cancers, HPV positivity documented per local institutional testing is required. For EBV-related solid tumors, EBV positivity documented per local institutional testing is required;
e. Metastatic triple-negative breast cancer (mTNBC);
f. Platinum-resistant epithelial ovarian cancer;
g. Metastatic castration-resistant prostate cancer (mCRPC);
h. Primary stage IV or recurrent non-small cell lung cancer (NSCLC);
i. Solid tumors generally considered as immunogenic (e.g., melanoma and renal cell carcinoma) are eligible without prior testing for TMB, MSI or viral status after the Sponsor s approval.
Other histologies may also be included in Phase 2 as additional data emerge to support their inclusion.
Tumor Specimen:
- Subjects must allow for acquisition of existing formalin-fixed paraffin-embedded archival tumor sample, either a block or unstained slides that had been procured within 3 months prior to enrollment, if available. The subject also must not have received intervening therapy between archival specimen collection and the first dose of STAR0602.
- If a study site cannot retrieve such existing archival tumor sample within 2 weeks after the initial attempt, or archival tumor is not available, the following subjects must consent to fresh baseline tumor biopsy during Screening:
--Dose Escalation (Phase 1) subjects: only after a dose escalation cohort is identified with clear evidence of STAR0602 biological effect (e.g., expansion of target T cell subsets, anti-tumor effect, or other relevant biomarker assessments), i.e., subjects still enrolling in this dose escalation cohort and at the higher dose levels thereafter;
--Backfill subjects (in Dose Escalation): the additional subjects enrolled in Dose Escalation at a dose level deemed below or at the MTD;
--Dose Expansion Cohort (Phase 2) subjects.
- Above subjects must also consent to a second tumor biopsy 21 days (+/- 3 days) after the first dose administration of STAR0602.
Laboratory Features:
- Acceptable laboratory parameters as follows:
--Albumin >= 3.0 g/dL;
--Platelet count >= 75 x 103/micro L;
--Hemoglobin >= 8.5 g/dL;
--Absolute neutrophil count >= 1.5 x 103/micro L;
--ALT/AST <= 3.0 x upper limit of normal (ULN);
--Total bilirubin <= 1.5 x ULN, except subjects with Gilbert s syndrome, who may be enrolled if the conjugated bilirubin is within normal limits;
--LDH <= 3 x ULN
--Calculated creatinine clearance >= 50 mL/min based on Cockcroft-Gault formula
Reproductive Features:
- Female subjects of childbearing potential (not surgically sterilized and between menarche and 1-year post-menopause) must have a negative serum (screening) or urine pregnancy test performed within 72 hours prior to the initiation of study drug administration. Female subjects of childbearing potential must be willing to use two forms of contraception throughout the study, from the time of consent through 60 days after the last dose of STAR0602. Examples of effective contraception are birth control pills, birth control patch (e.g., Ortho Evra), NuvaRing, intrauterine device, female condom, diaphragm with spermicide, cervical cap, use of a condom by the sexual partner, documented sterile sexual partner or documented evidence of surgical sterilization (e.g., tubal ligation or hysterectomy) at least 6 months prior to Screening. Abstinence is acceptable if this is the established and the preferred contraception method for the subject. It is not necessary to use any other method of contraception when complete abstinence is elected.
- Male subjects with partners of childbearing potential must use barrier contraception from the time of consent through 60 days after last dose of STAR0602 and must not donate sperm during this period. In addition, male subjects should also have their partners use contraception (as documented for female subjects) for the same period of time.
CNS Metastases:
- Symptomatic central nervous system (CNS) metastases must have been treated, be asymptomatic for >= 14 days, and meet the following at the time of enrollment:
--No concurrent treatment for CNS disease (e.g., surgery, radiation, corticosteroids > 10 mg prednisone/day or equivalent);
--No concurrent leptomeningeal disease or cord compression.
Previous Checkpoint Inhibitor Therapy:
-Subjects who have previously received a CPI (e.g., anti-PD-L1, anti-PD-1, anti-CTLA-4) prior to enrollment must have CPI immune-related toxicity resolved to either Grade <= 1 or baseline (prior to the CPI) to be eligible for enrollment.
--Subjects who experienced previous CPI-related endocrine abnormalities are eligible for the study regardless of CTCAE grade if well controlled on replacement therapy.
--Subjects who have had previous CPI-related Grade 3 to 4 pneumonitis, peri/myocarditis, colitis and bowel perforation, myositis, encephalitis, or peripheral neuropathy should be excluded.
EXCLUSION CRITERIA:
Subjects who meet any of the following criteria will be excluded from the study:
- Subjects with a history of known autoimmune disease with exceptions of:
--Vitiligo;
--Psoriasis, atopic dermatitis, or other autoimmune skin condition not requiring systemic treatment;
--History of Graves disease, now euthyroid for > 4 weeks;
--Hypothyroidism managed by thyroid replacement;
--Alopecia;
--Arthritis managed without systemic therapy beyond oral nonsteroidal anti- inflammatory drugs.
--Adrenal insufficiency- well controlled on replacement therapy.
- Major surgery or traumatic injury within 8 weeks before first dose of study drug.
- Unhealed wounds from surgery or injury.
- Treatment with >10 mg per day of prednisone (or equivalent) or other immune-suppressive drugs within 7 days prior to the initiation of study drug. Exceptions may be made for patients who have had allergic reaction to iodinated contrast media. Steroids for topical, ophthalmic, inhaled, or nasal administration are allowed.
- Prior therapy within the following timeframe before the planned infusion of STAR0602 as follows:
--Cytotoxic chemotherapy, small molecule inhibitors, radiation, interventional radiology procedure, or similar investigational therapies within <= 2 weeks or subjects who have not recovered (i.e., <= Grade 1 or to baseline) from AEs due to a previously administered agent;
--Monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, or similar investigational therapies within 6 weeks prior to the initiation of study drug or subjects who have not recovered (i.e., <= Grade 1 or to baseline) from AEs due to agents administered more than 6 weeks earlier.
Note: Subjects with <=Grade 2 neuropathy or <= Grade 2 alopecia are an exception to this criterion and may qualify for the study.
Note: Concurrent use of hormones either to maintain castrate levels of testosterone in subjects with castration-sensitive prostate cancer or for non-cancer-related conditions (e.g., insulin for diabetes, hormone replacement therapy) is acceptable. Bisphosphonates are permitted for supportive care of bone metastases (e.g., breast or prostate cancer).
- Clinically significant cardiovascular/vascular disease including:
--Myocardial infarction or unstable angina < 6 months prior to the initiation of study drug;
--Clinically significant cardiac arrhythmia (e.g., with potential for hemodynamic instability) not controlled or unresponsive to treatment;
--Uncontrolled hypertension: systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg; Subjects with systolic blood pressure > 140 mmHg but < 180 mmHg and/or diastolic blood pressure > 90 mmHg but < 100 mmHg may be enrolled upon reviewing co-morbidities/risks and after the sponsor approval. These subjects need to be closely monitored with their blood pressure assessed and managed at each visit on treatment;
--Pulmonary embolism, stroke, or transient ischemic attack < 6 months prior to initiation of STAR0602;
--QTcF (Fridericia correction) prolongation > 480 msec;
--Congestive heart failure (New York Heart Association Class III-IV);
--Pericarditis/clinically significant pericardial effusion;
--Myocarditis;
--Vasculitis that has not resolved within 6 months prior to study drug.
- Clinically significant gastrointestinal disorders including:
--Gastrointestinal perforation < 6 months prior to study drug administration. Subjects must have documented evidence (e.g., upper endoscopy, colonoscopy) of completely healed area of prior perforation;
--Gastrointestinal bleeding < 2 months prior to study drug administration. Subjects must have documented evidence (e.g., upper endoscopy, colonoscopy) of completely healed area of prior bleeding;
--Pancreatitis <6 months prior to the initiation of study drug. Subjects must have a CT scan negative for evidence of remaining disease or normal pancreatic enzyme levels for > 4 weeks prior to the initiation of study drug;
--Diverticulitis flare < 2 months prior to study drug administration. Subjects must have a CT scan negative for evidence of remaining disease prior to the initiation of study drug;
--History of Crohn s disease or ulcerative colitis.
- Inflammatory process that has not resolved for >= 4 weeks from the date of first study dose. Subjects with chronic low-grade inflammatory processes such as radiation-induced pneumonitis are excluded regardless of duration.
- Clinically significant pulmonary compromise (e.g., requirement for supplemental oxygen on a continuous basis).
- Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days prior to the initiation of study drug. Systemic antiviral, antifungal, or antibacterial therapy must be completed > 1 week prior to the initiation of study drug. Antimicrobial prophylaxis (e.g., for pneumocystis carinii infection) may continue the antimicrobial for that purpose.
- Vaccination with any live virus vaccine within 4 weeks prior to the initiation of study drug administration. Inactivated annual influenza vaccination is allowed.
- Subjects who are known to be human immunodeficiency virus (HIV) positive or hepatitis B or C positive and have uncontrolled disease. Subjects treated for hepatitis C must have viral titers below the limit of quantification to be eligible. Subjects with hepatitis B having undetectable or <= 500 IU/mL hepatitis B viral DNA are eligible for STAR0602. Subjects treated for HIV must have CD4+ T cell (CD4+) counts >= 350 cells/micro L and HIV viral load less than 400 copies/mL to be eligible.
- Second primary invasive malignancy not in remission for >= 1 year. Exceptions include non-melanoma locally advanced skin cancer, cervical carcinoma in situ, localized prostate cancer (Gleason score <= 7), resected melanoma in situ, or any malignancy considered to be indolent and never required systemic therapy, with the exception of indolent lymphomas.
-Any serious underlying medical or psychiatric condition that would preclude understanding and rendering of informed consent or impair the ability of the subject to receive or tolerate the planned treatment.
-Known hypersensitivity to STAR0602 or any excipient (histidine or polysorbate-80) contained in the drug or diluent formulation.
-Any medical (e.g., requirement of an indwelling catheter such as PleurX or Tenckhoff catheter) or non-medical issue that would contraindicate the subject s participation in the study or confound the results of the study.
-Pregnant, likely to become pregnant, or lactating women (where pregnancy is defined as the state of a female after conception and until the termination of gestation).
-Hepatic metastases unless adequately treated, either locally (e.g., by surgery, radiofrequency ablation, or chemoembolization) or systemically or both, and stable for 3 months.
Principal Investigator
Referral Contact
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