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M7437

Phase 1

Advanced Solid Tumors | Small molecule | Oncology |Merck & Company, Inc.|Last Updated: Aug 17, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment138

FDA Designations

No designations recorded

Clinical trial landscape

M7437 · 1 trial · 1 indication

Phase 1 1
NCT07360314Anti-Ly6E Exatecan ADC M7437 in Advanced Solid TumorsAdvanced Solid Tumors
RECRUITING138 Analytics
PHASE1RECRUITING
Anti-Ly6E Exatecan ADC M7437 in Advanced Solid Tumors
Advanced Solid Tumors
NCT07360314138
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Study Endpoints

Primary Endpoints

Dose-escalation Cohort: Occurences of Dose Limiting Toxicities (DLTs)
DLT period is 21 days (cycle 1)
Dose-escalation Cohort: Number of Participants With Treatment-Emergent Adverse Event (TEAEs) and Adverse Event (AEs)
Up to end of Part 1 of study (approximately 1 year 8 months)

Secondary Endpoints

Dose-escalation Cohort: Plasma Concentration of M7437
Cycle 1 Day 1: Pre-dose, 0.25, 6, 24, 96, 168 and 336 hours post-dose; Cycle 3 Day 1: Pre-dose, 0.25, 6 and 168 hours post-dose; Pre-dose at Day 1 of Cycles 2, 4, 6, 8 until end of treatment (approximately 1 year 8 months) (Each Cycle length=21 days)
Dose-escalation Cohort: Overall Response (OR) According to Response Evaluation Criteria inSolid Tumor (RECIST) version 1.1 criteria as Assessed by Investigator
From the date of first documented complete response (CR) or partial response (PR), whichever occurs first, until the first documented disease recurrence or progressive disease (PD) (assessed upto [approximately 1 year 8 months])
Change From The Baseline Qtc (Δqtc) At Predefined Timepoints Based on Triplicate Electrocardiogram (ECG) Measurements
Baseline, Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 5, Cycle 1 Day 8, Cycle 2 Day 1, Cycle 3 Day 1 (each cycle is of 21 days)
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeOTHER

Treatment Arms

ArmTypeDescription
Part 1: Dose-escalation CohortEXPERIMENTAL -
Part 2: Dose-Expansion CohortEXPERIMENTAL -

Interventions

NameTypeDescription
M7437DRUGParticipants will receive M7437 as an intravenous infusion at a dose corresponding to their assigned cohort. Dose escalation will occur between cohorts, with 3-4 participants enrolled at each dose level before proceeding to the next higher dose.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: * Participants have histologically proven advanced solid tumors with known prevalent and high Ly6E expression, Disease characteristic: Participants should have an unresectable locally advanced or metastatic solid tumor that is refractory to standard therapies, or have no standar...

Countries:United StatesCanadaJapanSpain
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Advanced Solid Tumors")

CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
AstraZeneca PLCAZN1 - Trastuzumab deruxtecan
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Recent Changes (Last 90 Days)

LOWAug 17, 2026NCT07360314lastUpdatePostDate: changed
LOWAug 17, 2026NCT07360314lastUpdatePostDate: changed
LOWJul 17, 2026NCT07360314lastUpdatePostDate: changed
LOWJul 17, 2026NCT07360314lastUpdatePostDate: changed
LOWJul 5, 2026NCT07360314lastUpdatePostDate: changed
LOWJul 5, 2026NCT07360314lastUpdatePostDate: changed
LOWJul 5, 2026NCT07360314lastUpdatePostDate: changed

Frequently asked questions about M7437

What is M7437 used for in advanced solid tumors?

M7437 is an investigational small molecule being studied for the treatment of advanced solid tumors. It is currently in Phase 1 clinical development, with an ongoing trial evaluating its safety and efficacy in patients with this condition. The drug is not yet approved and remains under investigation.

What does M7437 target?

M7437 is an anti-Ly6E exatecan antibody-drug conjugate, meaning it targets the Ly6E protein, which is expressed on certain tumor cells. The drug is designed to deliver the cytotoxic agent exatecan to Ly6E-positive cells, potentially leading to tumor cell death. This mechanism is being evaluated in clinical trials.

Who makes M7437?

M7437 is being developed by Merck & Company, Inc., a global pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The company is conducting clinical research on this investigational drug for advanced solid tumors.

What phase is M7437 in?

M7437 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The ongoing Phase 1 trial is recruiting participants to assess the drug's safety, tolerability, and preliminary efficacy in patients with advanced solid tumors.

What clinical trials is M7437 in?

M7437 is being studied in a single Phase 1 clinical trial with the identifier NCT07360314. This trial, titled 'Anti-Ly6E Exatecan ADC M7437 in Advanced Solid Tumors,' is currently recruiting participants. The study is enrolling approximately 138 patients across the United States, Canada, Japan, and Spain.

Is M7437 the same as an antibody-drug conjugate?

Yes, M7437 is an antibody-drug conjugate (ADC). It combines an antibody targeting Ly6E with the cytotoxic agent exatecan. This design allows the drug to specifically deliver chemotherapy to tumor cells expressing Ly6E, potentially reducing damage to healthy cells. This mechanism is under investigation in clinical trials.