Breast Cancer Clinical Trial
Official title:
A Phase 1/2, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SNS-101 (Anti VISTA) as Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors
Phase 1/2 study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of SNS-101, a novel anti VISTA IgG1 monoclonal antibody as monotherapy or in combination with cemiplimab in patients with advanced solid tumors.
Status | Recruiting |
Enrollment | 169 |
Est. completion date | June 2027 |
Est. primary completion date | June 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Key Inclusion Criteria: - Histologically or cytologically documented locally advanced, unresectable or metastatic solid tumor. - Having received and failed or was intolerant to standard of care for advanced disease or not eligible for standard of care therapy with the following tumor types for patients in Phase 1 dose expansion cohorts: 1. Microsatellite Stable (MSS) CRC (both monotherapy and combination cohorts); no more than 3 lines of prior systemic therapy for metastatic disease. 2. H&N cancer (combination cohort only); no more than 2 lines of prior systemic therapy for metastatic disease. 3. Melanoma (combination cohort only); no more than 3 lines of prior systemic therapy for metastatic disease, including at least 1 prior treatment with a BRAF inhibitor for patients with a BRAF mutation. 4. NSCLC (combination cohort only); no more than 2 lines of prior systemic therapy for metastatic disease, including at least 1 prior treatment with a targeted therapy for patients with a mutation such as EGFR, ALK, KRAS, or RET. 5. Patients with H&N cancer, melanoma, and NSCLC must not have demonstrated primary refractory disease to a prior PD-1/PD-L1 agent where the best response to that therapy was progressive disease. Additional tumor types and doses may be considered. - Measurable disease. - ECOG performance status 0 or 1. - Life expectancy of = 3 months. - Willing to provide pre-treatment (archival or fresh) and on-treatment tumor biopsy samples. - Adequate organ function - Women of childbearing potential and fertile males with WOCBP partners must use highly effective contraception during the study and for 180 days after the study. Patients must agree not to donate eggs (ova, oocytes) or sperm during the study. Key Exclusion Criteria: - 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. - Clinically significant unresolved toxicities from prior anticancer therapy. - Grade 3 or higher immune-related adverse event on prior PD-1/PD-L1 blockade or prior agents targeting stimulatory or co-inhibitory T cell receptor. - 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. - Known asymptomatic or symptomatic brain metastasis or leptomeningeal disease. - History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins. - Women who are pregnant or breastfeeding. |
Country | Name | City | State |
---|---|---|---|
United States | NEXT Oncology Dallas | Irving | Texas |
United States | Icahn School of Medicine at Mt. Sinai | New York | New York |
United States | South Texas Accelerated Research Therapeutics (START) San Antonio | San Antonio | Texas |
United States | Sanford Cancer Center | Sioux Falls | South Dakota |
United States | START Mountain Region | West Valley City | Utah |
Lead Sponsor | Collaborator |
---|---|
Sensei Biotherapeutics, Inc. | Regeneron Pharmaceuticals |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adverse Events - Part A & B | Incidence, nature and severity of treatment-related adverse events | Day 1 through 90 days after the last dose | |
Primary | Determine the Recommended Phase 2 dose or maximum tolerated dose - Part A & B | Incidence and nature of dose-limiting toxicities | Approximately 15 months | |
Primary | Objective Response Rate (ORR) - Part C | Measured by RECIST 1.1 and iRECIST | Day 1 through study completion (approximately 1 year) | |
Secondary | Determine pharmacokinetic profile (maximum concentration) of SNS-101 - Part A, B & C | Measured by maximum concentration | Day 1 through 30 days after the last dose | |
Secondary | Determine pharmacokinetic profile (area under the curve) of SNS-101 - Part A, B & C | Measured by area under the curve | Day 1 through 30 days after the last dose | |
Secondary | Determine pharmacokinetic profile (total clearance) of SNS-101 - Part A, B & C | Measured by total clearance | Day 1 through 30 days after the last dose | |
Secondary | Determine pharmacokinetic profile (terminal half life) of SNS-101 - Part A, B & C | Measured by serum terminal half-life | Day 1 through 30 days after the last dose | |
Secondary | Number of participants with anti-SNS-101 antibodies post-administration of SNS-101 - Part A, B & C | Measured by anti-SNS-101 neutralizing anti-drug antibodies | Day 1 through 30 days after the last dose | |
Secondary | Objective Response Rate (ORR) - Part A & B | Measured by RECIST 1.1 and iRECIST | Day 1 through study completion (approximately 1 year) | |
Secondary | Duration of Response (DoR) - Part A, B & C | Measured by RECIST 1.1 and iRECIST | Day 1 through study completion (approximately 1 year) | |
Secondary | Disease Control Rate (DCR) - Part A, B & C | Measured by RECIST 1.1 and iRECIST | Day 1 through study completion (approximately 1 year) | |
Secondary | Progression Free Survival - Part A, B and C | Measured by RECIST 1.1 and iRECIST | Day 1 through study completion - approximately 1 year (Part A, B & C) | |
Secondary | Adverse Events - Part C | Incidence, nature and severity of treatment-related adverse events | Day 1 through study completion (approximately 1 year) |
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