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SNS-101

Phase 1

Solid Tumor, Adult | Small molecule | Oncology |Sensei Biotherapeutics, Inc.|Last Updated: Aug 15, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment98
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05864144A Study of SNS-101 (Anti VISTA) Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid TumorsPHASE1 ACTIVE NOT_RECRUITING 98May 31, 2023Jun 1, 2027Aug 15, 202510 United States
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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
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
Day 1 through 30 days after the last dose
Determine pharmacokinetic profile (area under the curve) of SNS-101 - Part A, B & C
Day 1 through 30 days after the last dose
Determine pharmacokinetic profile (total clearance) of SNS-101 - Part A, B & C
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 will 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 will 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.
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 — 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)
LOWMay 26, 2026NCT05864144primaryCompletionDate: changed
LOWMay 24, 2026NCT05864144studyFirstPostDate: changed