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M9466

Phase 1

Advanced Solid Tumor | Small molecule | Oncology |Merck KGaA|Last Updated: Sep 9, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

Clinical trial landscape

M9466 · 1 trial · 1 indication

Phase 1 1
NCT06421935M9466 Alone or in Combination in Advanced Solid Tumors (DDriver 501)Advanced Solid Tumor
ACTIVE NOT_RECRUITING60 Analytics
PHASE1ACTIVE NOT_RECRUITING
M9466 Alone or in Combination in Advanced Solid Tumors (DDriver 501)
Advanced Solid Tumor
NCT0642193560
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Study Endpoints

Primary Endpoints

Module 1 Part A1 and Part A2: Number of Participants With Treatment-Emergent Adverse Events (TEAE), and Treatment-related AEs (TRAEs)
Time from first treatment up to 30 days after end of study intervention (approximately assessed up to 20 months)
Module 1 Part A1 and Part A2: Number of Participants with Dose Limiting Toxicity (DLT)-like events
Day 1 up to Day 21 of Cycle 1 (each cycle is of 21 days)
Module 2 Part A1: Pharmacokinetic (PK) Plasma Concentrations of M9466
Cycle 1 Day 1 (C1D1), C1D8 and C1D15
Module 2 Part A2: Number of Participants With Treatment-Emergent Adverse Events (TEAE), and Treatment-related AEs (TRAEs)
Time from first treatment up to 30 days after end of study intervention (approximately assessed up to 20 months)
Module 3 Part A1: Number of Participants With Treatment-Emergent Adverse Events (TEAE), and Treatment-related AEs
Time from first treatment up to 30 days after end of study intervention
Module 3 Part A1: Number of Participants with Dose Limiting Toxicity (DLT)-like Events
Day 1 up to Day 21 of Cycle 1(each cycle is of 21 days)

Secondary Endpoints

Module 1 Part A1 and Part A2, Module 2 Part A1 and A2 and Module 3 Part A1: Pharmacokinetic (PK) Plasma Concentrations of M9466 and Tuvusertib
Module 1 Part A1: C1D1 and C1D5 or C1D6; Module 1 Part A2: C1D1, C1D2, C1D3 or C1D4 and C1D8; Module 2 Part A1: C1D1, C1D8 and C1D15; Module 2 Part A2: C1D1, C1D2 and C1D8, C1D22 and C2D1; Module 2 Part A1: C1D1 and C1D8
Module 1 Part A1 and Part A2, Module 2 Part A2: Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (or PCWG3 for prostate cancer) as Assessed by Investigator
Time from first treatment to planned assessment at 12 months
Module 1 Part A1 and Part A2; Module 2 Part A1 : Effect of M9466 in combination with tuvusertib on QTc interval as determined by Digital ECGs
Time from first treatment to planned assessment at 12 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
M9466 plus TuvusertibEXPERIMENTAL -
M9466 MonotherapyEXPERIMENTAL -
M9466 with AA-P(abiraterone acetate and prednisone or prednisolone)EXPERIMENTAL -

Interventions

NameTypeDescription
M9466DRUGParticipants will be administered M9466 orally.
TuvusertibDRUGParticipants will be administered Tuvusertib orally.
Abiraterone acetateDRUGParticipants will be administered with Abiraterone acetate orally.
Prednisone/PrednisoloneDRUGParticipants will be administered with prednisone/prednisolone orally.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites20

Inclusion Criteria: * Module 1 Part A and Module 2 Part A1: Locally advanced or metastatic disease that is refractory to standard therapy or for which no standard therapy is judged appropriate by the Investigator * Module 1 Part A2: Histologically or pathologically confirmed advanced or metastatic ...

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

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, 2026NCT06421935lastUpdatePostDate: changed
LOWSep 9, 2026NCT06421935lastUpdatePostDate: changed
LOWJul 5, 2026NCT06421935lastUpdatePostDate: changed
LOWJul 5, 2026NCT06421935lastUpdatePostDate: changed
LOWJul 5, 2026NCT06421935lastUpdatePostDate: changed