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M9466 Alone or in Combination in Advanced Solid Tumors (DDriver 501)

NCT06421935 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-06-30

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic profile of M9466 with and without tuvusertib or an ARPi and early signs of clinical activity of M9466 with tuvusertib in participants with advanced solid tumors. Study details include: Study/Treatment Duration: Participants will be treated until disease progression, death, discontinuation, or End of Study. Visit Frequency: Every week in the first 2 cycles, followed by every 3 weeks in the subsequent cycles. An End of Treatment Visit and Safety Follow-up/Discontinuation Visit are scheduled after the treatment period.

Conditions

  • Advanced Solid Tumor

Interventions

DRUG

M9466

Participants will be administered M9466 orally.

DRUG

Tuvusertib

Participants will be administered Tuvusertib orally.

DRUG

Abiraterone acetate

Participants will be administered with Abiraterone acetate orally.

DRUG

Prednisone/Prednisolone

Participants will be administered with prednisone/prednisolone orally.

Sponsors & Collaborators

  • Merck KGaA, Darmstadt, Germany

    collaborator INDUSTRY

  • EMD Serono Research & Development Institute, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Responsible · EMD Serono Research & Development Institute, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-07
Primary Completion
2027-02-22
Completion
2027-02-22
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Japan
  • South Korea
  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06421935 on ClinicalTrials.gov