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M7437

Phase 1

Advanced Solid Tumors | Small molecule | Oncology |Merck KGaA|Trials Updated: Oct 20, 2026

M7437 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jan 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment138

FDA Designations

No designations recorded

M7437 clinical trials

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 TumorsUnlock trial analytics

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 10 trials (matched to "Advanced Solid Tumors")

Recent Changes (Last 90 Days)

LOWOct 20, 2026NCT07360314lastUpdatePostDate: changed
LOWOct 20, 2026NCT07360314lastUpdatePostDate: changed
LOWSep 29, 2026NCT07360314primaryCompletionDate: changed
LOWSep 29, 2026NCT07360314primaryCompletionDate: changed
LOWSep 9, 2026NCT07360314lastUpdatePostDate: changed
LOWSep 9, 2026NCT07360314lastUpdatePostDate: changed
LOWAug 17, 2026NCT07360314lastUpdatePostDate: changed
LOWAug 17, 2026NCT07360314lastUpdatePostDate: changed

Frequently asked questions about M7437

What is M7437?

M7437 is an investigational small molecule being developed by Merck KGaA for the treatment of advanced solid tumors. It is in Phase 1 clinical development and is being studied in a biomarker-selected patient population. M7437 has not been approved for any indication and remains an experimental therapy in early-stage testing.

What is M7437 used for in advanced solid tumors?

M7437 is being evaluated for the treatment of advanced solid tumors in adults. The Phase 1 study enrolls patients 18 years and older with advanced solid tumors across the United States, Canada, Japan, and Spain. It is investigational and has not been approved for treating solid tumors or any other condition.

Who is developing M7437?

M7437 is being developed by Merck KGaA, which trades over the counter in the United States under the ticker MKGAF. The company is running the Phase 1 program for the drug in advanced solid tumors. Merck KGaA is the sole sponsor identified for the M7437 clinical program.

What phase is M7437 in?

M7437 is in Phase 1 clinical development. It is an investigational agent and has not received FDA approval. The single registered trial is currently recruiting participants, and no trials for M7437 have been completed. The program remains in early-stage clinical testing for advanced solid tumors.

What clinical trials is M7437 in?

M7437 is being studied in one clinical trial, NCT07360314, titled Anti-Ly6E Exatecan ADC M7437 in Advanced Solid Tumors. The Phase 1 study is recruiting and plans to enroll 138 participants with advanced solid tumors. It is a controlled, non-randomized, open-label trial without double blinding, conducted in the United States, Canada, Japan, and Spain.