ACTIVE_NOT_RECRUITING

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

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Conditions

Solid Tumor, AdultAdvanced Solid TumorHead and Neck CancerBreast CancerColon CancerPancreatic CancerGastric CancerEsophageal CancerProstate CancerUterine CancerCervix CancerOvarian CancerKidney CancerBladder CancerThyroid CancerMelanomaSarcomaAdvanced CancerMetastatic CancerRefractory CancerNon Small Cell Lung CancerMerkel Cell CarcinomaSolnerstotug

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2023-05-31
Study Completion:2027-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05864144

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Histologically or cytologically documented locally advanced, unresectable or metastatic solid tumor.
  2. * 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:
  3. 1. Microsatellite Stable (MSS) CRC (both monotherapy and combination cohorts); no more than 3 lines of prior systemic therapy for metastatic disease.
  4. 2. H\&N cancer (combination cohort only); no more than 2 lines of prior systemic therapy for metastatic disease.
  5. 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.
  6. 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.
  7. 5. Patients with H\&N cancer, melanoma, and NSCLC (or additional tumor types that typically respond to PD1/PD-L1 monotherapy) must have received a prior PD1/PD-L1 where best response was stable disease and progression occurred during treatment or within 3 months of last dose of PD1/PD-L1.
  8. * Measurable disease
  9. * ECOG performance status 0 or 1.
  10. * Life expectancy of ≥ 3 months.
  11. * Willing to provide pre-treatment (archival or fresh) and on-treatment tumor biopsy samples.
  12. * Adequate organ function
  13. * 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.
  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.
  3. * 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.
  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.
  6. * History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.
  7. * Women who are pregnant or breastfeeding.

Contacts and Locations

Principal Investigator

Ron Weitzman, MD
STUDY_DIRECTOR
Sensei Biotherapeutics, Inc.

Study Locations (Sites)

UCLA Hematology/Oncology
Los Angeles, California, 90095
United States
University of Colorado Cancer Center - Anschutz Medical
Aurora, Colorado, 80045
United States
Norton Healthcare
Louisville, Kentucky, 40202
United States
Henry Ford Cancer
Detroit, Michigan, 48202
United States
Icahn School of Medicine at Mt. Sinai
New York, New York, 10029
United States
University of Pennsylvania, Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104
United States
Sanford Cancer Center
Sioux Falls, South Dakota, 57104
United States
NEXT Oncology Dallas
Irving, Texas, 75039
United States
South Texas Accelerated Research Therapeutics (START) San Antonio
San Antonio, Texas, 78229
United States
START Mountain Region
West Valley City, Utah, 84119
United States

Collaborators and Investigators

Sponsor: Sensei Biotherapeutics, Inc.

  • Ron Weitzman, MD, STUDY_DIRECTOR, Sensei Biotherapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-31
Study Completion Date2027-06

Study Record Updates

Study Start Date2023-05-31
Study Completion Date2027-06

Terms related to this study

Keywords Provided by Researchers

  • Solnerstotug

Additional Relevant MeSH Terms

  • 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
  • Non Small Cell Lung Cancer
  • Merkel Cell Carcinoma