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SNS-101

Phase 1

Solid Tumor, Adult | Small molecule | Oncology |Faeth Therapeutics, Inc. Common Stock|Last Updated: Sep 2, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment98

FDA Designations

No designations recorded

Clinical trial landscape

SNS-101 · 1 trial · 22 indications

Phase 1 1
NCT05864144A Study of SNS-101 (Anti VISTA) Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid TumorsSolid Tumor, Adult
COMPLETED98 Analytics
PHASE1COMPLETED
A Study of SNS-101 (Anti VISTA) Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors
Solid Tumor, AdultUnlock trial analytics

Study Endpoints

Primary Endpoints

Adverse Events - Part A & B
Day 1 through 90 days after the last dose

Incidence, nature and severity of treatment-related adverse events

Determine the Recommended Phase 2 dose or maximum tolerated dose - Part A & B
Approximately 15 months

Incidence and nature of dose-limiting toxicities

Objective Response Rate (ORR) - Part C. Part C was never initiated.
Day 1 through study completion (approximately 1 year).

Measured by RECIST 1.1 and iRECIST

Secondary Endpoints

Determine pharmacokinetic profile (maximum concentration) of SNS-101 - Part A, B.& C. Part C was never initiated.
Day 1 through 30 days after the last dose
Determine pharmacokinetic profile (area under the curve) of SNS-101 - Part A, B & C. Part C was never initiated.
Day 1 through 30 days after the last dose
Determine pharmacokinetic profile (total clearance) of SNS-101 - Part A, B & C. Part C was never initiated.
Day 1 through 30 days after the last dose
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part A - SNS-101 Monotherapy Dose Escalation and Dose ExpansionEXPERIMENTALSNS-101 IV alone every 21 days. Patients initially enroll in dose escalation cohorts.
Part B - SNS-101 in combination with cemiplimab and Dose ExpansionEXPERIMENTALSNS-101 IV and cemiplimab IV every 21 days. Patients initially enroll in dose escalation cohorts.
Part C - Cohort Expansion - SNS-101 alone or in combination with cemiplimabEXPERIMENTALSNS-101 IV alone or in combination with cemplimab IV every 21 days at the RP2D. Following completion of the Phase 1 Parts A and B portions of the study, the Phase 2, Part C portion was never initiated. No participants were enrolled in Part C.

Interventions

NameTypeDescription
SNS-101 (anti-VISTA)DRUGSNS-101 IV every 21 days.
CemiplimabDRUGCemiplimab IV every 21 days.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites10

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 pati...

Countries:United States
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Recent Changes (Last 90 Days)

HIGHSep 2, 2026NCT05864144Status: ACTIVE_NOT_RECRUITING → COMPLETED
HIGHSep 2, 2026NCT05864144Status: ACTIVE_NOT_RECRUITING → COMPLETED
HIGHSep 2, 2026NCT05864144Status: ACTIVE_NOT_RECRUITING → COMPLETED

Frequently asked questions about SNS-101

What is SNS-101 used for?

SNS-101 is an investigational small molecule being studied for the treatment of advanced solid tumors in adults, including 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, non-small cell lung cancer, and Merkel cell carcinoma.

What does SNS-101 target?

SNS-101 is an anti-VISTA agent, meaning it targets VISTA (V-domain Ig suppressor of T cell activation), an immune checkpoint protein. By targeting VISTA, SNS-101 is designed to modulate the immune system's response to tumors, potentially enhancing the body's ability to fight cancer cells.

Who is developing SNS-101?

SNS-101 is being developed by Sensei Biotherapeutics, Inc., a biopharmaceutical company. The company is listed on the stock exchange under the ticker symbol FTH.

What phase is SNS-101 in?

SNS-101 is currently in Phase 1 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The ongoing Phase 1 trial is evaluating the safety, tolerability, and preliminary efficacy of SNS-101 as a monotherapy and in combination with cemiplimab.

What clinical trials is SNS-101 in?

SNS-101 is being studied in a Phase 1 clinical trial with the identifier NCT05864144. This trial is evaluating SNS-101 as a monotherapy and in combination with cemiplimab in patients with advanced solid tumors. The study has an enrollment of 98 participants and is being conducted in the United States.

Is SNS-101 the same as anti-VISTA?

SNS-101 is an anti-VISTA agent, meaning it is a drug that targets the VISTA protein. While SNS-101 is the specific drug name, it is often referred to as an anti-VISTA therapy in the context of its mechanism of action. The drug is being investigated for its potential to treat various advanced solid tumors.