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FS120

Phase 1

Advanced Cancer | Small molecule | Oncology |Merck & Company, Inc.|Last Updated: Jun 27, 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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment82
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04648202FS120 Phase 1/1b Study in Patients With Advanced MalignanciesPHASE1 ACTIVE NOT_RECRUITING 82Nov 18, 2020Mar 1, 2026Jun 27, 20259 United States, Spain
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Study Endpoints
Primary Endpoints
Incidence, severity, and duration of adverse events (AEs), serious adverse events (SAEs) and dose limiting toxicities (DLTs)
24 months

Safety and tolerability will be evaluated by collection of AEs, SAEs and DLTs according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0.

Determination of a maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D)
24 months

Toxicity will be evaluated according to the NCI CTCAE Version 5.0.

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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
FS120EXPERIMENTALOpen-label study where FS120 will be administered as monotherapy or in combination with pembrolizumab in dose escalation and expansion cohorts
Interventions
NameTypeDescription
FS120DRUGDosing of participants with FS120 or the combination pembrolizumab will occur intravenously (IV), at a fixed dose in treatment cycles once every 4 weeks (Q4W) or once every 3 weeks (Q3W) until confirmed progressive disease (CPD)/immune-confirmed progressive disease (iCPD) or unacceptable toxicity.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: * Measurable disease * Eastern Cooperative Oncology Group Performance Status 0-1. * Highly effective contraception if risk of conception exists * A female subject is eligible if not pregnant, not breastfeeding, not a woman of childbearing potential (WOCBP) or is a WOCBP that use...

Countries:United StatesSpain
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