M9466 Alone or in Combination in Advanced Solid Tumors (DDriver 501)
Condition(s) studied
Investigational drug(s) / intervention(s)
M9466: Participants will be administered M9466 orally.
Tuvusertib: Participants will be administered Tuvusertib orally.
Abiraterone acetate: Participants will be administered with Abiraterone acetate orally.
Prednisone/Prednisolone: Participants will be administered with prednisone/prednisolone orally.
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.
Eligibility
Primary outcome measure(s)
- 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)
Trial sites (20)
| Facility | City | Region | Status |
|---|---|---|---|
| NEXT Oncology - PARENT | New York | New York | |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | |
| Cancer Research SA | Adelaide | Australia | |
| GenesisCare North Shore (Oncology) | St Leonards | Australia | |
| Harasanshin Hospital | Fukuoka | Japan | |
| National Cancer Center Hospital East - Dept of Experimental Therapeutics | Kashiwa-shi | Japan | |
| Cancer Institute Hospital of JFCR | Kōtoku | Japan | |
| NHO Kumamoto Medical Center - Dept of Urology | Kumamoto | Japan | |
| Seoul National University Bundang Hospital | Seongnam | South Korea | |
| Asan Medical Center | Seoul | South Korea | |
| Samsung Medical Center | Seoul | South Korea | |
| Seoul National University Hospital | Seoul | South Korea | |
| Severance Hospital, Yonsei University Health System - Division of Infectious Diseases | Seoul | South Korea | |
| Hospital HM Nou Delfos - START Barcelona | Barcelona | Spain | |
| Hospital Universitari Vall d'Hebron - Oncology Dept. | Barcelona | Spain | |
| ICO l'Hospitalet - Hospital Duran i Reynals - Servicio de Oncologia | Barcelona | Spain | |
| Centro Integral Oncologico Clara Campal - Unidad de Fase I-Oncologica | Madrid | Spain | |
| Hospital Universitario 12 de Octubre - Servicio de Oncologia | Madrid | Spain | |
| Hospital Universitario Fundacion Jimenez Diaz - START Madrid FJD - Oncology Phase I | Madrid | Spain | |
| NEXT Madrid - Hospital Universitario Quironsalud Madrid | Pozuelo de Alarcón | Spain |
More EMD Serono Research & Development Institute, Inc. trials in South Korea
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06421935 on ClinicalTrials.gov ↗ ← All trials in South Korea