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

Primary Purpose

Solid Tumor, Adult, Advanced Solid Tumor, Head and Neck Cancer

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SNS-101 (anti-VISTA)
Cemiplimab
Sponsored by
Sensei Biotherapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Solid Tumor, Adult

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • NEXT Oncology DallasRecruiting
  • South Texas Accelerated Research Therapeutics (START) San AntonioRecruiting
  • START Mountain RegionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Part A - SNS-101 Monotherapy

Part B - SNS-101 in combination with cemiplimab

Part C - Expansion Cohorts - SNS-101 alone or in combination with cemiplimab

Arm Description

SNS-101 IV alone every 21 days. Patients will enroll in dose escalation cohorts.

SNS-101 IV and cemiplimab IV every 21 days. Patients will enroll in dose escalation cohorts.

SNS-101 IV alone or in combination with cemplimab IV every 21 days at the RP2D.

Outcomes

Primary Outcome Measures

Adverse Events - Part A & B
Incidence, nature and severity of treatment-related adverse events
Determine the Recommended Phase 2 dose or maximum tolerated dose - Part A & B
Incidence and nature of dose-limiting toxicities
Objective Response Rate (ORR) - Part C
Measured by RECIST 1.1 and iRECIST

Secondary Outcome Measures

Determine pharmacokinetic profile (maximum concentration) of SNS-101 - Part A, B & C
Measured by maximum concentration
Determine pharmacokinetic profile (area under the curve) of SNS-101 - Part A, B & C
Measured by area under the curve
Determine pharmacokinetic profile (total clearance) of SNS-101 - Part A, B & C
Measured by total clearance
Determine pharmacokinetic profile (terminal half life) of SNS-101 - Part A, B & C
Measured by serum terminal half-life
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
Objective Response Rate (ORR) - Part A & B
Measured by RECIST 1.1 and iRECIST
Duration of Response (DoR) - Part A, B & C
Measured by RECIST 1.1 and iRECIST
Disease Control Rate (DCR) - Part A, B & C
Measured by RECIST 1.1 and iRECIST
Progression Free Survival - Part A, B and C
Measured by RECIST 1.1 and iRECIST
Adverse Events - Part C
Incidence, nature and severity of treatment-related adverse events

Full Information

First Posted
April 21, 2023
Last Updated
September 8, 2023
Sponsor
Sensei Biotherapeutics, Inc.
Collaborators
Regeneron Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT05864144
Brief Title
A Study of SNS-101 (Anti VISTA) Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 31, 2023 (Actual)
Primary Completion Date
June 2027 (Anticipated)
Study Completion Date
June 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sensei Biotherapeutics, Inc.
Collaborators
Regeneron Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
129 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Part A - SNS-101 Monotherapy
Arm Type
Experimental
Arm Description
SNS-101 IV alone every 21 days. Patients will enroll in dose escalation cohorts.
Arm Title
Part B - SNS-101 in combination with cemiplimab
Arm Type
Experimental
Arm Description
SNS-101 IV and cemiplimab IV every 21 days. Patients will enroll in dose escalation cohorts.
Arm Title
Part C - Expansion Cohorts - SNS-101 alone or in combination with cemiplimab
Arm Type
Experimental
Arm Description
SNS-101 IV alone or in combination with cemplimab IV every 21 days at the RP2D.
Intervention Type
Drug
Intervention Name(s)
SNS-101 (anti-VISTA)
Intervention Description
SNS-101 IV every 21 days.
Intervention Type
Drug
Intervention Name(s)
Cemiplimab
Intervention Description
Cemiplimab IV every 21 days.
Primary Outcome Measure Information:
Title
Adverse Events - Part A & B
Description
Incidence, nature and severity of treatment-related adverse events
Time Frame
Day 1 through 90 days after the last dose
Title
Determine the Recommended Phase 2 dose or maximum tolerated dose - Part A & B
Description
Incidence and nature of dose-limiting toxicities
Time Frame
Approximately 15 months
Title
Objective Response Rate (ORR) - Part C
Description
Measured by RECIST 1.1 and iRECIST
Time Frame
Day 1 through study completion (approximately 1 year)
Secondary Outcome Measure Information:
Title
Determine pharmacokinetic profile (maximum concentration) of SNS-101 - Part A, B & C
Description
Measured by maximum concentration
Time Frame
Day 1 through 30 days after the last dose
Title
Determine pharmacokinetic profile (area under the curve) of SNS-101 - Part A, B & C
Description
Measured by area under the curve
Time Frame
Day 1 through 30 days after the last dose
Title
Determine pharmacokinetic profile (total clearance) of SNS-101 - Part A, B & C
Description
Measured by total clearance
Time Frame
Day 1 through 30 days after the last dose
Title
Determine pharmacokinetic profile (terminal half life) of SNS-101 - Part A, B & C
Description
Measured by serum terminal half-life
Time Frame
Day 1 through 30 days after the last dose
Title
Number of participants with anti-SNS-101 antibodies post-administration of SNS-101 - Part A, B & C
Description
Measured by anti-SNS-101 neutralizing anti-drug antibodies
Time Frame
Day 1 through 30 days after the last dose
Title
Objective Response Rate (ORR) - Part A & B
Description
Measured by RECIST 1.1 and iRECIST
Time Frame
Day 1 through study completion (approximately 1 year)
Title
Duration of Response (DoR) - Part A, B & C
Description
Measured by RECIST 1.1 and iRECIST
Time Frame
Day 1 through study completion (approximately 1 year)
Title
Disease Control Rate (DCR) - Part A, B & C
Description
Measured by RECIST 1.1 and iRECIST
Time Frame
Day 1 through study completion (approximately 1 year)
Title
Progression Free Survival - Part A, B and C
Description
Measured by RECIST 1.1 and iRECIST
Time Frame
Day 1 through study completion - approximately 1 year (Part A, B & C)
Title
Adverse Events - Part C
Description
Incidence, nature and severity of treatment-related adverse events
Time Frame
Day 1 through study completion (approximately 1 year)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Janine McDermott
Phone
781-392-5556
Email
jmcdermott@senseibio.com
First Name & Middle Initial & Last Name or Official Title & Degree
Joelle Lufkin
Email
jlufkin@senseibio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ron Weitzman, MD
Organizational Affiliation
Sensei Biotherapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
NEXT Oncology Dallas
City
Irving
State/Province
Texas
ZIP/Postal Code
75039
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erica Torres
Phone
737-610-5180
Email
etorres@nextoncology.com
Facility Name
South Texas Accelerated Research Therapeutics (START) San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabel Jimenez, RN, MSN
Phone
210-593-5265
Email
isabel.jimenez@startsa.com
Facility Name
START Mountain Region
City
West Valley City
State/Province
Utah
ZIP/Postal Code
84119
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie Asay
Phone
801-907-4770
Email
marie.asay@startthecure.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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