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FS120

Phase 1

Advanced Cancer | Small molecule | Oncology |Merck & Company, Inc.|Last Updated: Jun 27, 2025

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment82

FDA Designations

No designations recorded

Clinical trial landscape

FS120 · 1 trial · 2 indications

Phase 1 1
NCT04648202FS120 Phase 1/1b Study in Patients With Advanced MalignanciesAdvanced Cancer
ACTIVE NOT_RECRUITING82 Analytics
PHASE1ACTIVE NOT_RECRUITING
FS120 Phase 1/1b Study in Patients With Advanced Malignancies
Advanced CancerUnlock trial analytics

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 to 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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Competitive Landscape -Cancer 5 trials (matched to "Advanced Cancer")

Frequently asked questions about FS120

What is FS120 used for?

FS120 is an investigational small molecule being developed for the treatment of advanced cancer, including metastatic cancer. It is currently in Phase 1 clinical development and has not been approved by the FDA. The drug is being studied in patients with advanced malignancies.

Who makes FS120?

FS120 is being developed by Merck & Company, Inc., which trades under the ticker MRK. The company is conducting clinical trials to evaluate the safety and efficacy of FS120 in patients with advanced cancer.

What phase is FS120 in?

FS120 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA and is still being studied in clinical trials. The ongoing trial is a Phase 1/1b study in patients with advanced malignancies.

What clinical trials is FS120 in?

FS120 is being studied in a Phase 1/1b clinical trial with the identifier NCT04648202. This trial is titled 'FS120 Phase 1/1b Study in Patients With Advanced Malignancies' and is currently active but not recruiting. The study enrolls 82 participants with advanced or metastatic cancer.

Is FS120 being studied in a randomized controlled trial?

No, the FS120 clinical trial is not randomized and does not use a control group. It is an uncontrolled study, meaning all participants receive FS120 without comparison to a placebo or standard treatment. The trial is also not double-blinded.

Where is the FS120 clinical trial being conducted?

The FS120 clinical trial is being conducted in the United States and Spain. The study enrolls adults aged 18 years and older of all sexes. It is an open-label trial that does not include healthy volunteers.