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Clinical Trials in Australia / NCT06421935
Active, not recruiting Phase 1

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

NCT06421935 · tracked via the Priya Life Science Australia tracker
Phase
Phase 1
Started
2024-08-07
Last updated
2026-09-09

Condition(s) studied

Advanced Solid Tumor

Investigational drug(s) / intervention(s)

M9466 →Tuvusertib →Abiraterone acetate →Prednisone/Prednisolone →

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 CRPC or EOC * Eastern Cooperative Oncology Group Performance Status less than or equal to (\<=) 1 * Life expectancy of more than 6 months * Have adequate hematologic function * Participants who received chemotherapy, extensive radiotherapy, biological therapy (e.g. antibodies) or investigational agents will have a washout period of 4 weeks (6 weeks for nitrosourea, mitomycin-C) or 5 half-lives whichever is shorter, prior to starting study intervention with M9466 (± tuvusertib) * Module 3 Part A1: * Histologically or pathologically confirmed diagnosis of prostate cancer * Metastatic disease documented by positive bone scan or metastatic lesions on CT or MRI * Participants with Metastatic Castration-Resistant Prostate Cancer (mCRPC) or metastatic hormone-sensitive prostate cancer (mHSPC) are allowed. For mCRPC, serum testosterone levels ≤ 50 /dL (≤ 1.75 nmol/L). * Ongoing ADT with a GnRH agonist or antagonist for participants who have not undergone bilateral orchiectomy must be initiated before first dose and must continue throughout the study. * Candidate for treatment with ·abiraterone acetate. * Prior anticancer therapy allowed for mHSPC or mCRPC * Other protocol defined inclusion criteria could apply Exclusion Criteria: * Persistence of Adverse Events related to any prior treatments that have not recovered to Grade less than 1 by NCI Common Terminology Criteria for Adverse Events- v5.0 unless AEs are clinically nonsignificant and/or stable on supportive therapy in the opinion of the Investigator (e.g. neuropathy or alopecia) * Participant has a history of additional malignancy within 5 years before the date of enrollment other than disease under study (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, benign prostate neoplasm/hypertropia, or malignancy that in the opinion of the Investigator, with concurrence of the Sponsor's Medical Monitor, is considered cured with minimal risk of recurrence within 3 years) * Participants with known brain metastases, except if clinically controlled, which is defined as individuals with Central Nervous System (CNS) tumors that have been treated, are asymptomatic and who have discontinued steroids (for the treatment of CNS tumors) for more than 28 days * Serious Gastrointestinal bleeding within 3 months, refractory nausea and vomiting, uncontrolled diarrhea, known malabsorption, significant small bowel resection or gastric bypass surgery, use of feeding tubes, other chronic gastrointestinal disease (including exocrine pancreatic insufficiency requiring pancreatic enzyme replacement therapy), and/or other situations that may preclude adequate absorption of oral medications * Cerebrovascular accident or stroke * Module 3 only: * Current evidence of any of the following: 1. Any medical condition that would make prednisone (or equivalent) use contraindicated. 2. Any chronic medical condition requiring a higher dose of corticosteroid than 10 mg prednisone (or equivalent) once daily. * History of uncontrolled pituitary or adrenal dysfunction * Hypokalemia * Other protocol defined exclusion criteria could apply

Primary outcome measure(s)

Trial sites (20)

FacilityCityRegionStatus
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 Australia

Other trials for the same condition

Official registry record

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 Australia