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Brief Title: SNS-101 (Anti VISTA) Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors

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

INTRODUCTION

  • Org Study ID: SNS-101-2-1
  • Secondary ID: N/A
  • NTC ID: NCT05864144
  • Sponsor: Sensei Biotherapeutics, Inc.

BRIEF 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.

DETAILED 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 (SNS-101 alone)
Part B: Phase 1 Combination Dose Escalation (SNS-101 in combination with cemiplimab)
Part C: Phase 2 Expansion Cohorts (SNS-101 alone or in combination with cemiplimab)

  • Overall Status
    Recruiting
  • Start Date
    June 2023
  • Phase
    Phase 1, Phase 2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Adverse Events - Part A & B

Primary Outcome 1 - Timeframe: Day 1 through 90 days after the last dose

Primary Outcome 2 - Measure: Determine the Recommended Phase 2 dose or maximum tolerated dose - Part A & B

Primary Outcome 2 - Timeframe: Approximately 15 months

Primary Outcome 3 - Measure: Objective Response Rate (ORR) - Part C

Primary Outcome 3 - Timeframe: Day 1 through study completion (approximately 1 year)

CONDITION

  • Solid Tumor
  • Adult
  • Advanced Solid Tumor
  • Head and Neck Cancer
  • Breast Cancer
  • Colon Cancer
  • Pancreatic Cancer
  • Gastric Cancer
  • Esophageal Cancer
  • Prostate Cancer
  • Uterine Cancer
  • Cervix Cancer
  • Ovarian Cancer
  • Kidney Cancer
  • Bladder Cancer
  • Thyroid Cancer
  • Melanoma
  • Sarcoma
  • Advanced Cancer
  • Metastatic Cancer
  • Refractory Cancer

ELIGIBILITY

Key Inclusion Criteria:
Histologically or cytologically documented locally advanced, unresectable or metastatic solid tumor.

- Refractory or intolerant to standard of care for advanced disease or not eligible for standard of care therapy.

- 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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Ron Weitzman, MD

Role: Study Director

Affiliation: Sensei Biotherapeutics, Inc.

Overall Contact

Name: Ron Weitzman, MD

Phone: 240-243-8000

Email: jlufkin@senseibio.com

LOCATION

Facility Status Contact
Facility: NEXT Oncology Dallas
Irving, Texas 75039
United States
Status: Recruiting Contact: Contact
Erica Torres
737-610-5180
etorres@nextoncology.com
Facility: South Texas Accelerated Research Therapeutics (START) San Antonio
San Antonio, Texas 78229
United States
Status: Recruiting Contact: Contact
Isabel Jimenez, RN, MSN
210-593-5265
isabel.jimenez@startsa.com
Facility: START Mountain Region
West Valley City, Utah 84119
United States
Status: Recruiting Contact: Contact
Marie Asay
801-907-4770
marie.asay@startthecure.com