This study is NOT currently recruiting participants.
Number
001695-C
Sponsoring Institute
National Cancer Institute (NCI)
Recruitment Detail
Type: Recruitment has not started Gender: Male & Female Min Age: 18 Years Max Age: 120 Years
Referral Letter Required
No
Population Exclusion(s)
Children;Fetuses;Neonates;Pregnant Women
Keywords
Cemiplimab; Antineoplastic Agents; Antineoplastic Agents, Immunological
Recruitment Keyword(s)
None
Condition(s)
Urogenital Neoplasms; Neoplasms by Site; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Neoplasms, Female; Urologic Neoplasms; Urologic Diseases; Kidney Diseases; Uterine Diseases; Uterine Cervical Diseases; Neoplasms; Kidney Neoplasms; Uterine Neoplasms; Uterine Cervical Neoplasms
Investigational Drug(s)
SNS-101 (anti-VISTA) cemiplimab-rwlc (Libtayo)
Investigational Device(s)
Intervention(s)
Drug: SNS-101 Drug: Cemiplimab
Supporting Site
National Cancer Institute
Immunotherapies are treatments that harness the body s own immune system to fight diseases such as cancers. Many of these treatments use antibodies, which are natural blood proteins that fight infections. But some people are resistant to certain immunotherapies. SNS-101 is a new monoclonal antibody that may help immune cells kill cancer cells without resistance issues.
Objective:
To test SNS-101, alone or combined with another drug (cemiplimab), in people with advanced cancers.
Eligibility:
Adults aged 18 years or older with cancer that is advanced, cannot be removed by surgery, or has spread to other organs.
Design:
Participants will be screened. They will have a physical exam. They will have blood and urine tests. They will have tests of their heart function. They will have imaging scans. They will have a biopsy: A small sample of tissue will be cut from their tumor. These tests may be done in more than 1 visit. The screening period may last 28 days.
Treatment will be in 21-day cycles. SNS-101 and cemiplimab are both given through a tube attached to a needle inserted in a vein in the arm. All participants will receive SNS-101 once every 3 weeks; research doctors will determine the dosage, which may vary. Some participants will also receive cemiplimab.
Biopsies, imaging scans, and other tests will be repeated at various times during study visits.
Participants may remain in the study as long as the treatment is helping them.
Those who end treatment will have a final visit 30 days after their last dose of SNS-101. They will have a follow-up call after 90 days.
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INCLUSION CRITERIA: Patients must meet all eligibility criteria to be considered for enrollment into the study. Protocol waivers for eligibility will not be permitted. Patients who meet all of the following criteria may be eligible to participate in the study: 1. Provide signed IRB/IEC approved informed consent in accordance with institutional guidelines. 2. Is 18 years of age or older at the time of signing the informed consent form (ICF). 3. Histologically or cytologically documented locally advanced, unresectable or metastatic solid tumor. 4. Refractory or intolerant to standard of care for advanced disease or not candidates for standard of care therapy (i.e., patient refusal, medical contraindication, etc.). 5. Measurable disease, as defined by RECIST version 1.1 (Investigator assessment). 6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. 7. Have a life expectancy of >= 3 months. 8. Be willing to provide pre-treatment (archival or fresh) and on-treatment tumor biopsy samples assuming they are deemed by the Investigator to be safe and accessible. 9. Adequate organ function per below: Hematological: ANC >= 1500/microL Platelets >= 75,000/microL Hemoglobin >= 9 g/dL without transfusion within 7 days Renal: Calculated creatinine clearance >= 45 mL/min Note: Creatinine clearance should be calculated per Cockcroft-Gault formula using ideal body weight Hepatic: Total bilirubin <= 1.5 X ULN; OR <= 3 X ULN for patients with liver metastases or Gilbert s disease AST (SGOT) and ALT (SGPT) <= 3.0 X ULN; OR <= 5 X ULN for patients with liver metastases Coagulation: International Normalized Ratio (INR) or Prothrombin Time (PT); and Activated Partial Thromboplastin Time (aPTT) <=1.5 X ULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants 10. Fertility criteria: -Women of childbearing potential (WOCBP) and fertile males with WOCBP partners must use highly effective contraception (failure rate <1%) during the study and for 180 days after the study. -Patients must agree not to donate eggs (ova, oocytes) or sperm during the study and for 180 days after the study. EXCLUSION CRITERIA: Patients who meet any of the following criteria will not be eligible to participate in the study: Cancer-Specific Exclusion Criteria: 1. Use of anti-PD-1/PD-L1 targeting monoclonal antibody therapy, monoclonal antibody therapy, chemotherapy, biologic, investigational, or radiotherapy within 2 weeks of Cycle 1 Day 1. 2. Clinically significant unresolved toxicities from prior anticancer therapy (presence of CTCAE >= Grade 2 toxicity excluding Grade 2 neuropathy or alopecia). 3. Grade 3 or higher immune related AE on prior PD-1/PD-L1 blockade or prior agents targeting stimulatory or co-inhibitory T cell receptor. NOTE: Patients with >= Grade 3 endocrinopathies on prior PD-1/PDL-1 blockade that are adequately controlled with hormone supplementation may be included in the study. 4. Known other previous/current malignancy requiring treatment within <= 2 years except for limited disease treated with curative intent, such as carcinoma in situ, squamous or basal cell skin carcinoma, or superficial bladder carcinoma. 5. Known asymptomatic or symptomatic brain metastasis or leptomeningeal disease. General Medical Exclusion Criteria: 6. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins. 7. Known hypersensitivity allergy or contraindication to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the PD-1/PD-L1 inhibitor formulation; and for patients receiving combination, known hypersensitivity to cemiplimab or any of its excipients or contraindicated to cemiplimab per approved local labeling. 8. Active or inactive autoimmune disease or syndrome (e.g., rheumatoid arthritis, moderate or severe psoriasis, multiple sclerosis, inflammatory bowel disease) that has required systemic treatment in the past 2 years or who are receiving systemic therapy for autoimmune or inflammatory disease (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). NOTE: Vitiligo, resolved childhood asthma/atopy, hypothyroidism, stable on hormone replacement, controlled asthma, Type 1 diabetes, Grave s disease or Hashimoto s disease or with Medical Monitor approval, will be eligible if all other eligibility criteria are met. 9. Medical illness requiring systemic glucocorticoid use of > 10 mg/day prednisone equivalent (inhaled, topical, and intranasal steroids are allowed) within 14 days of Cycle 1 Day 1. 10. History of transient ischemic attack, cerebrovascular accident, or seizures within the last 12 months. 11. Personal or familial history of hemophagocytic lymphohistiocytosis or macrophage activation syndrome. 12. QTc > 480 msec (average of triplicate measurements at Screening) according to Fredericia s QT correction formula. 13. Clinically significant cardiovascular disease such as uncontrolled congestive heart failure (NYHA Class 2-4), unstable angina, myocardial infarction, coronary/peripheral artery bypass graft surgery in the prior 6 months. Pulmonary embolism is exclusionary if the patient is not on a stable dose of anti-coagulant. 14. History of non-infectious pneumonitis or interstitial pulmonary disease that required steroids or ongoing pneumonitis or interstitial pulmonary disease. 15. Has uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C (HCV) infection; or has a diagnosis of immunodeficiency. Notes: -Patients with known HIV infection who have controlled infection (undetectable viral load (HIV RNA PCR) and CD4 count above 350 either spontaneously or on a stable antiviral regimen) are permitted. For patients with controlled HIV infection, monitoring will be performed per local standards. -Patients with hepatitis B (HBsAg+) who have controlled infection (serum hepatitis B virus DNA PCR that is below the limit of detection and receiving anti-viral therapy for hepatitis B) are permitted. Patients with controlled infections must undergo periodic monitoring of HBV DNA. Patients must remain on anti-viral therapy for at least 6 months beyond the last dose of investigational study drug. -Patients who are hepatitis C virus antibody positive (HCV Ab+) who have controlled infection (undetectable HCV RNA by PCR either spontaneously or in response to a successful prior course of anti-HCV therapy) may be enrolled into the study. 16. Ongoing active infection requiring systemic antibiotics or viral infection. 17. Uncontrolled intercurrent condition, therapy or laboratory abnormality that could confound the results of the trial or limit the patient s study compliance. 18. Prior allogeneic stem cell or solid organ transplant. 19. Received a live, attenuated vaccine within 28 days prior to Cycle 1 Day 1, or anticipation that such a live attenuated vaccine will be required during the trial. 20. Known previous or ongoing, active psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. 21. Major surgery within 4 weeks prior to Cycle 1 Day 1. 22. Women who are pregnant or breastfeeding.
Patients must meet all eligibility criteria to be considered for enrollment into the study. Protocol waivers for eligibility will not be permitted.
Patients who meet all of the following criteria may be eligible to participate in the study:
1. Provide signed IRB/IEC approved informed consent in accordance with institutional guidelines.
2. Is 18 years of age or older at the time of signing the informed consent form (ICF).
3. Histologically or cytologically documented locally advanced, unresectable or metastatic solid tumor.
4. Refractory or intolerant to standard of care for advanced disease or not candidates for standard of care therapy (i.e., patient refusal, medical contraindication, etc.).
5. Measurable disease, as defined by RECIST version 1.1 (Investigator assessment).
6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
7. Have a life expectancy of >= 3 months.
8. Be willing to provide pre-treatment (archival or fresh) and on-treatment tumor biopsy samples assuming they are deemed by the Investigator to be safe and accessible.
9. Adequate organ function per below:
Hematological:
ANC >= 1500/microL
Platelets >= 75,000/microL
Hemoglobin >= 9 g/dL without transfusion within 7 days
Renal:
Calculated creatinine clearance >= 45 mL/min
Note: Creatinine clearance should be calculated per Cockcroft-Gault formula using ideal body weight
Hepatic:
Total bilirubin <= 1.5 X ULN; OR <= 3 X ULN for patients with liver metastases or Gilbert s disease
AST (SGOT) and ALT (SGPT) <= 3.0 X ULN; OR <= 5 X ULN for patients with liver metastases
Coagulation:
International Normalized Ratio (INR) or Prothrombin Time (PT); and Activated Partial Thromboplastin Time (aPTT) <=1.5 X ULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
10. Fertility criteria:
-Women of childbearing potential (WOCBP) and fertile males with WOCBP partners must use highly effective contraception (failure rate <1%) during the study and for 180 days after the study.
-Patients must agree not to donate eggs (ova, oocytes) or sperm during the study and for 180 days after the study.
EXCLUSION CRITERIA:
Patients who meet any of the following criteria will not be eligible to participate in the study:
Cancer-Specific Exclusion Criteria:
1. Use of anti-PD-1/PD-L1 targeting monoclonal antibody therapy, monoclonal antibody therapy, chemotherapy, biologic, investigational, or radiotherapy within 2 weeks of Cycle 1 Day 1.
2. Clinically significant unresolved toxicities from prior anticancer therapy (presence of CTCAE >= Grade 2 toxicity excluding Grade 2 neuropathy or alopecia).
3. Grade 3 or higher immune related AE on prior PD-1/PD-L1 blockade or prior agents targeting stimulatory or co-inhibitory T cell receptor. NOTE: Patients with >= Grade 3 endocrinopathies on prior PD-1/PDL-1 blockade that are adequately controlled with hormone supplementation may be included in the study.
4. Known other previous/current malignancy requiring treatment within <= 2 years except for limited disease treated with curative intent, such as carcinoma in situ, squamous or basal cell skin carcinoma, or superficial bladder carcinoma.
5. Known asymptomatic or symptomatic brain metastasis or leptomeningeal disease.
General Medical Exclusion Criteria:
6. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.
7. Known hypersensitivity allergy or contraindication to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the PD-1/PD-L1 inhibitor formulation; and for patients receiving combination, known hypersensitivity to cemiplimab or any of its excipients or contraindicated to cemiplimab per approved local labeling.
8. Active or inactive autoimmune disease or syndrome (e.g., rheumatoid arthritis, moderate or severe psoriasis, multiple sclerosis, inflammatory bowel disease) that has required systemic treatment in the past 2 years or who are receiving systemic therapy for autoimmune or inflammatory disease (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). NOTE: Vitiligo, resolved childhood asthma/atopy, hypothyroidism, stable on hormone replacement, controlled asthma, Type 1 diabetes, Grave s disease or Hashimoto s disease or with Medical Monitor approval, will be eligible if all other eligibility criteria are met.
9. Medical illness requiring systemic glucocorticoid use of > 10 mg/day prednisone equivalent
(inhaled, topical, and intranasal steroids are allowed) within 14 days of Cycle 1 Day 1.
10. History of transient ischemic attack, cerebrovascular accident, or seizures within the last 12 months.
11. Personal or familial history of hemophagocytic lymphohistiocytosis or macrophage activation syndrome.
12. QTc > 480 msec (average of triplicate measurements at Screening) according to Fredericia s QT correction formula.
13. Clinically significant cardiovascular disease such as uncontrolled congestive heart failure (NYHA Class 2-4), unstable angina, myocardial infarction, coronary/peripheral artery bypass graft surgery in the prior 6 months. Pulmonary embolism is exclusionary if the patient is not on a stable dose of anti-coagulant.
14. History of non-infectious pneumonitis or interstitial pulmonary disease that required steroids or ongoing pneumonitis or interstitial pulmonary disease.
15. Has uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C (HCV) infection; or has a diagnosis of immunodeficiency.
Notes:
-Patients with known HIV infection who have controlled infection (undetectable viral load (HIV RNA PCR) and CD4 count above 350 either spontaneously or on a stable antiviral regimen) are permitted. For patients with controlled HIV infection, monitoring will be performed per local standards.
-Patients with hepatitis B (HBsAg+) who have controlled infection (serum hepatitis B virus DNA PCR that is below the limit of detection and receiving anti-viral therapy for hepatitis B) are permitted. Patients with controlled infections must undergo periodic monitoring of HBV DNA. Patients must remain on anti-viral therapy for at least 6 months beyond the last dose of investigational study drug.
-Patients who are hepatitis C virus antibody positive (HCV Ab+) who have controlled infection (undetectable HCV RNA by PCR either spontaneously or in response to a successful prior course of anti-HCV therapy) may be enrolled into the study.
16. Ongoing active infection requiring systemic antibiotics or viral infection.
17. Uncontrolled intercurrent condition, therapy or laboratory abnormality that could confound the results of the trial or limit the patient s study compliance.
18. Prior allogeneic stem cell or solid organ transplant.
19. Received a live, attenuated vaccine within 28 days prior to Cycle 1 Day 1, or anticipation that such a live attenuated vaccine will be required during the trial.
20. Known previous or ongoing, active psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
21. Major surgery within 4 weeks prior to Cycle 1 Day 1.
22. Women who are pregnant or breastfeeding.
Principal Investigator
Referral Contact
For more information: