A Study of SNS-101 (Anti VISTA) Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05864144
• Other study ID #: SNS-101-2-1
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: May 31, 2023
• Est. completion date: June 2027

Study information

• Verified date: February 2024
• Source: Sensei Biotherapeutics, Inc.
• Contact: Janine McDermott
• Phone: 781-392-5556
• Email: jmcdermott[@]senseibio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

This is a first-in-human, Phase 1/2 open-label, multi-center, dose escalation and expansion 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. This study is being conducted in three parts: - Part A: Phase 1 Monotherapy Dose Escalation and Dose Expansion (SNS-101 alone) - Part B: Phase 1 Combination Dose Escalation and Dose Expansion (SNS-101 in combination with cemiplimab) - Part C: Phase 2 Cohort Expansion (SNS-101 alone or in combination with cemiplimab) Once the MTD/RP2D is determined, enrollment will expand to targeted tumor types: - Up to 10 patients with colorectal cancer (CRC) will be enrolled in the Monotherapy Dose Expansion at the monotherapy MTD/RP2D. o Additional tumor types and doses may be considered upon consultation with the Sponsor. - Up to 30 patients with CRC, head and neck cancer (H&N), melanoma, and non-small cell lung cancer (NSCLC) will be enrolled in the Combination Dose Expansion at the combination MTD/RP2D. - A minimum of 8 and a maximum of 10 CRC patients will be enrolled in the Combination Dose Expansion. - Additional tumor types and doses may be considered upon consultation with the Sponsor.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Advanced Cancer
• Advanced Solid Tumor
• Bladder Cancer
• Breast Cancer
• Cervix Cancer
• Colon Cancer
• Esophageal Cancer
• Gastric Cancer
• Head and Neck Cancer
• Kidney Cancer
• Kidney Neoplasms
• Melanoma
• Metastatic Cancer
• Neoplasms
• Non Small Cell Lung Cancer
• Ovarian Cancer
• Pancreatic Cancer
• Prostate Cancer
• Refractory Cancer
• Sarcoma
• Solid Tumor, Adult
• Thyroid Cancer
• Uterine Cancer
• Uterine Cervical Neoplasms
• Uterine Neoplasms

Intervention

Drug:
• SNS-101 (anti-VISTA)
SNS-101 IV every 21 days.
• Cemiplimab
Cemiplimab IV every 21 days.

Locations

Country	Name	City	State
United States	NEXT Oncology Dallas	Irving	Texas
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

Sponsors (2)

Lead Sponsor	Collaborator
Sensei Biotherapeutics, Inc.	Regeneron Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

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)