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M7437

Phase 1

Advanced Solid Tumors | Small molecule | Oncology |Merck KGaA|Last Updated: Sep 9, 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)

LOWSep 9, 2026NCT07360314lastUpdatePostDate: changed
LOWSep 9, 2026NCT07360314lastUpdatePostDate: changed
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