This study is currently recruiting participants.
Number
001776-C
Sponsoring Institute
National Cancer Institute (NCI)
Recruitment Detail
Type: Participants currently recruited/enrolled Gender: Male & Female Min Age: 18 Years Max Age: 120 Years
Referral Letter Required
No
Population Exclusion(s)
Fetuses;Neonates;Pregnant Women;Children
Keywords
CTLA-4; GIGA-564
Recruitment Keyword(s)
None
Condition(s)
Neoplasms
Investigational Drug(s)
GIGA-564
Investigational Device(s)
Intervention(s)
Drug: GIGA-564
Supporting Site
National Cancer Institute
GIGA-564 is a new drug that will be tested for its ability to help the immune system fight cancer in people. It is a monoclonal antibody. MonoDrugs called monoclonal antibodies are a type of protein and they are often used to treat cancer. A monoclonal antibody is a type of. Antibodies like GIGA-564 are designed to protein that can bind itself to other specificbind to proteins in the bodyproteins expressed on the surface of immune cells. Through this binding, changes to the immune system can occur. Investigators working for this study are testing to see if giving GIGA-564 to people When one of these monoclonal antibodies binds to proteins found only on tumor cells, the drug may causes their the tumors to shrink or stop growing. Researchers want to know if a new monoclonal antibody drug called GIGA-564 can help shrink tumors.
Objective:
To test the safety and anti-cancer of GIGA-564 in people with advanced solid cancers.
Eligibility:
People aged 18 years and older with advanced solid cancer that has not responded to or stopped responding to prior treatments.
Design:
Participants will be screened. To assess eligibility for the study, individuals hey will undergo screening evaluation to include have a physical exam with blood and urine tests. They will have tests of their heart function. They will have imaging scans. Individuals who enroll to a later part of the study will have two tumor biopsiesThey will have a biopsy: A small sample of tissue will be taken from the tumor.
GIGA-564 is given intravenously. Intravenously means that a drug is given through a tube attached to a needle inserted into a vein in the arm. Participants will be treated with this drug 4 times: once every 3 weeks for a total of 12 weeks. They will remain at the clinic for monitoring for at least 8 hours after the first and second doses.
Biopsy and blood tests will be repeated during the study.
Participants will have imaging scans every 6 weeks for the first 24 weeks.
Participants will have follow-up visits for 13 weeks after treatment. If the tumor has not grown, follow-up visits, including imaging scans every 12 weeks, will continue for up to 2 years.
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The eligibility criteria in PROTRAK is numbered, asp erINCLUSION CRITERIA: A patient must meet all the following inclusion criteria to be eligible for participation in this study. 1. Adults >= 18 years of age at time of consent, inclusive. 2. Willing and able to provide informed consent. 3. Histologically or cytologically confirmed locally advanced or radiographically confirmed metastatic solid tumor malignancies ineligible for standard-of-care or refractory to or relapsing after at least one line of systemic therapy in the advanced or metastatic setting. 4. Measurable disease on imaging as based on RECIST 1.1. 5. Eastern Cooperative Oncology Group (ECOG) performance status of <= 1. 6. Life expectancy greater than three months. 7. Electrocardiogram (ECG) without evidence of clinically relevant abnormalities in rhythm, conduction, or morphology of resting ECG or active ischemia as determined by the Investigator. 8. Acceptable organ and marrow function including: a. Absolute neutrophil count > 1,500 cells/microL b. Platelets > 100,000 cells/microL c. Hemoglobin > 10 g/dL d. Total bilirubin <= 1.5 X the upper limit of normal (ULN) (<= 3 X ULN if attributable to known Gilbert s syndrome) e. Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) <= 2.5 X ULN. If liver metastasis is present, AST/ALT < 5 X ULN f. Measured creatinine clearance >= 30 mL/min per Cockcroft-Gault formula g. Prothrombin time or international normalized ratio (INR) and partial thromboplastin time (PTT) <= 1.5 X ULN, unless receiving anti-coagulant therapy 9. Women of childbearing potential must agree to use highly effective contraception which includes combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, or vasectomized partner (Clinical Trial Facilitation Group 2014) prior to study entry and for 90 days after the last dose. A woman is considered of childbearing potential following menarche and until becoming postmenopausal (no menses for at least 2 years without an alternative cause). Male participants must use a barrier method contraception from study entry until 90 days after the last dose. Note: Abstinence is acceptable if this is the established and preferred contraception for the participant. If the partner/partners cannot become pregnant (eg, hysterectomy, post-menopausal, partners of the same sex) a request, if desired, will be made to the medical monitor that the male participant does not need to use protection. 10. Primary tumor or metastatic lesions that are amenable to biopsy (Phase 1B only). EXCLUSION CRITERIA: A patient meeting any of the following exclusion criteria is NOT eligible for participation in the study. 1. Investigational therapy and/or anti-cancer therapy with the potential for late onset toxicity within 4 weeks or 5 half-lives (whichever is shorter), or nitrosoureas or mitomycin C within 6 weeks. FDA-approved hormonal therapies (eg, androgen deprivation therapy [ADT] for prostate cancer, anti-estrogen for breast cancer, somatostatin analogue for neuroendocrine cancer) are allowed. 2. Failure to resolve toxicity from previous anti-cancer therapy (other NCI CTCAE v5.0 <= Grade 2 alopecia, neuropathy or medically controlled endocrinopathies) to NCI CTCAE v5.0 <= Grade 1. 3. Prior receipt of therapy directed against CTLA-4. 4. Prior receipt of therapy directed against chemokine (C-C motif) receptor 8 (CCR8), cluster of differentiation 25 (CD25), or T cell immunoreceptor with immunoglobulin and immunoreceptor tyrosine-based inhibition motif domains (TIGIT) with an active Fc domain. 5. Baseline prolongation of QT/QTc interval Fridericia s formula (QTcF > 470 msec). 6. History of hepatitis B (HBV) infection unless viral load is undetectable. 7. Participants with known history of hepatitis C (HCV) infection, unless they have been treated and cured (viral load is undetectable). 8. Active severe infection such as active tuberculosis. 9. HIV infection unless participants are stable on anti-retroviral therapy (CD4 count >= 200/microL) and have a viral load < 400 copies/mL. 10. Significant cardiovascular disease (such as New York Heart Association Class II or greater heart failure), myocardial infarction within 3 months prior to initiation of study treatment, or cerebrovascular accident within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina. 11. Active or history of autoimmune or primary immunodeficiency disease requiring systemic treatment within 2 years of commencing study (NOTE: participants with autoimmune conditions requiring hormone replacement therapy or topical treatments are eligible). 12. Active or history of inflammatory bowel disease (e.g., Crohn s disease, ulcerative colitis). 13. History of hematopoietic stem cell transplantation or solid organ transplant with the exception of corneal transplants. 14. Pregnancy or breastfeeding. 15. Previous hypersensitivity reactions to any component of the IP. 16. Concurrent use of systemic steroids (within 10 days of enrollment), except for physiologic doses of systemic steroid replacement or local (topical, nasal, or inhaled) steroid use. Limited doses of systemic steroids (e.g., in participants with exacerbations of reactive airway disease) must have completed therapy >= 10 days prior to enrollment. Steroid use to prevent IV contrast allergic reaction or anaphylaxis in participants who have known contrast allergies is allowed at any time prior to enrollment and for imaging while on treatment. 17. History of other active malignancy within 3 years of enrollment except for the following: adequately treated localized skin cancer, ductal carcinoma in situ, cervical carcinoma in situ, superficial bladder cancer or other localized malignancy which has been adequately treated. 18. Active or untreated brain metastases that are not stable. Stable is defined as 2 brain images that show no progression, obtained >= 4 weeks apart and any neurologic symptoms that developed either as a result of the brain metastases or their treatment must have resolved. Any steroids administered as part of this therapy must be completed >= 10 days prior to first dose of study medication. 19. Other medical or psychiatric condition or laboratory abnormality that may increase risk associated with study participation or study drug administration or that may interfere with the interpretation of study results and which, in the judgment of the Investigator or Sponsor, would make the patient inappropriate for the study.
A patient must meet all the following inclusion criteria to be eligible for participation in this study.
1. Adults >= 18 years of age at time of consent, inclusive.
2. Willing and able to provide informed consent.
3. Histologically or cytologically confirmed locally advanced or radiographically confirmed metastatic solid tumor malignancies ineligible for standard-of-care or refractory to or relapsing after at least one line of systemic therapy in the advanced or metastatic setting.
4. Measurable disease on imaging as based on RECIST 1.1.
5. Eastern Cooperative Oncology Group (ECOG) performance status of <= 1.
6. Life expectancy greater than three months.
7. Electrocardiogram (ECG) without evidence of clinically relevant abnormalities in rhythm, conduction, or morphology of resting ECG or active ischemia as determined by the Investigator.
8. Acceptable organ and marrow function including:
a. Absolute neutrophil count > 1,500 cells/microL
b. Platelets > 100,000 cells/microL
c. Hemoglobin > 10 g/dL
d. Total bilirubin <= 1.5 X the upper limit of normal (ULN) (<= 3 X ULN if attributable to known Gilbert s syndrome)
e. Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) <= 2.5 X ULN. If liver metastasis is present, AST/ALT < 5 X ULN
f. Measured creatinine clearance >= 30 mL/min per Cockcroft-Gault formula
g. Prothrombin time or international normalized ratio (INR) and partial thromboplastin time (PTT) <= 1.5 X ULN, unless receiving anti-coagulant therapy
9. Women of childbearing potential must agree to use highly effective contraception which includes combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device, intrauterine
hormone-releasing system, bilateral tubal occlusion, or vasectomized partner (Clinical Trial Facilitation Group 2014) prior to study entry and for 90 days after the last dose. A woman is considered of childbearing potential following menarche and until becoming postmenopausal (no menses for at least 2 years without an alternative cause). Male participants must use a barrier method contraception from study entry until 90 days after the last dose. Note: Abstinence is acceptable if this is the established and preferred contraception for the participant. If the partner/partners cannot become pregnant (eg, hysterectomy, post-menopausal, partners of the same sex) a request, if desired, will be made to the medical monitor that the male participant does not need to use protection.
10. Primary tumor or metastatic lesions that are amenable to biopsy (Phase 1B only).
EXCLUSION CRITERIA:
A patient meeting any of the following exclusion criteria is NOT eligible for participation in the study.
1. Investigational therapy and/or anti-cancer therapy with the potential for late onset toxicity within 4 weeks or 5 half-lives (whichever is shorter), or nitrosoureas or mitomycin C within 6 weeks. FDA-approved hormonal therapies (eg, androgen deprivation therapy [ADT] for prostate cancer, anti-estrogen for breast cancer, somatostatin analogue for neuroendocrine cancer) are allowed.
2. Failure to resolve toxicity from previous anti-cancer therapy (other NCI CTCAE v5.0 <= Grade 2 alopecia, neuropathy or medically controlled endocrinopathies) to NCI CTCAE v5.0 <= Grade 1.
3. Prior receipt of therapy directed against CTLA-4.
4. Prior receipt of therapy directed against chemokine (C-C motif) receptor 8 (CCR8), cluster of differentiation 25 (CD25), or T cell immunoreceptor with immunoglobulin and immunoreceptor tyrosine-based inhibition motif domains (TIGIT) with an active Fc domain.
5. Baseline prolongation of QT/QTc interval Fridericia s formula (QTcF > 470 msec).
6. History of hepatitis B (HBV) infection unless viral load is undetectable.
7. Participants with known history of hepatitis C (HCV) infection, unless they have been treated and cured (viral load is undetectable).
8. Active severe infection such as active tuberculosis.
9. HIV infection unless participants are stable on anti-retroviral therapy (CD4 count >= 200/microL) and have a viral load < 400 copies/mL.
10. Significant cardiovascular disease (such as New York Heart Association Class II or greater heart failure), myocardial infarction within 3 months prior to initiation of study treatment, or cerebrovascular accident within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina.
11. Active or history of autoimmune or primary immunodeficiency disease requiring systemic treatment within 2 years of commencing study (NOTE: participants with autoimmune conditions requiring hormone replacement therapy or topical treatments are eligible).
12. Active or history of inflammatory bowel disease (e.g., Crohn s disease, ulcerative colitis).
13. History of hematopoietic stem cell transplantation or solid organ transplant with the exception of corneal transplants.
14. Pregnancy or breastfeeding.
15. Previous hypersensitivity reactions to any component of the IP.
16. Concurrent use of systemic steroids (within 10 days of enrollment), except for physiologic doses of systemic steroid replacement or local (topical, nasal, or inhaled) steroid use. Limited doses of systemic steroids (e.g., in participants with exacerbations of reactive airway disease) must have completed therapy >= 10 days prior to enrollment. Steroid use to prevent IV contrast allergic reaction or
anaphylaxis in participants who have known contrast allergies is allowed at any time prior to enrollment and for imaging while on treatment.
17. History of other active malignancy within 3 years of enrollment except for the following: adequately treated localized skin cancer, ductal carcinoma in situ, cervical carcinoma in situ, superficial bladder cancer or other localized malignancy which has been adequately treated.
18. Active or untreated brain metastases that are not stable. Stable is defined as 2 brain images that show no progression, obtained >= 4 weeks apart and any neurologic symptoms that developed either as a result of the brain metastases or their treatment must have resolved. Any steroids administered as part of this therapy must be completed >= 10 days prior to first dose of study medication.
19. Other medical or psychiatric condition or laboratory abnormality that may increase risk associated with study participation or study drug administration or that may interfere with the interpretation of study results and which, in the judgment of the Investigator or Sponsor, would make the patient inappropriate for the study.
Principal Investigator
Referral Contact
For more information: