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

Last updated: April 8, 2025
Sponsor: EMD Serono Research & Development Institute, Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Neoplasms

Treatment

Abiraterone acetate

Prednisone/Prednisolone

Tuvusertib

Clinical Study ID

NCT06421935
MS202659_0001
2024-513492-41-00
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • Module 1 Part A1 and Module 2 Part A1: Locally advanced or metastatic disease thatis refractory to standard therapy or for which no standard therapy is judgedappropriate by the Investigator

  • 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 (6weeks for nitrosourea, mitomycin-C) or 5 half-lives whichever is shorter, prior tostarting 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 CTor MRI

  • Participants with Metastatic Castration-Resistant Prostate Cancer (mCRPC) ormetastatic 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 notundergone bilateral orchiectomy must be initiated before first dose and mustcontinue 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

Exclusion Criteria:

  • Persistence of Adverse Events related to any prior treatments that have notrecovered to Grade less than 1 by NCI Common Terminology Criteria for AdverseEvents- v5.0 unless AEs are clinically nonsignificant and/or stable on supportivetherapy in the opinion of the Investigator (e.g. neuropathy or alopecia)

  • Participant has a history of malignancy within 5 years before the date of enrollment (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situof the cervix, benign prostate neoplasm/hypertropia, or malignancy that in theopinion of the Investigator, with concurrence of the Sponsor's Medical Monitor, isconsidered cured with minimal risk of recurrence within 3 years)

  • Participants with known brain metastases, except if clinically controlled, which isdefined as individuals with Central Nervous System (CNS) tumors that have beentreated, are asymptomatic and who have discontinued steroids (for the treatment ofCNS tumors) for more than 28 days

  • Serious Gastrointestinal bleeding within 3 months, refractory nausea and vomiting,uncontrolled diarrhea, known malabsorption, significant small bowel resection orgastric bypass surgery, use of feeding tubes, other chronic gastrointestinal disease (including exocrine pancreatic insufficiency requiring pancreatic enzyme replacementtherapy), and/or other situations that may preclude adequate absorption of oralmedications

  • Cerebrovascular accident or stroke

  • Module 3 only:

  • Current evidence of any of the following:

  1. Any medical condition that would make prednisone (or equivalent) usecontraindicated.
  2. Any chronic medical condition requiring a higher dose of corticosteroidthan 10 mg prednisone (or equivalent) once daily.
  • History of uncontrolled pituitary or adrenal dysfunction

  • Hypokalemia

  • Other protocol defined exclusion criteria could apply

Study Design

Total Participants: 96
Treatment Group(s): 4
Primary Treatment: Abiraterone acetate
Phase: 1
Study Start date:
August 07, 2024
Estimated Completion Date:
March 26, 2026

Connect with a study center

  • Please Contact the Communication Center

    Darmstadt, 64293
    Germany

    Site Not Available

  • Harasanshin Hospital

    Fukuoka-shi,
    Japan

    Active - Recruiting

  • National Cancer Center Hospital East - Dept of Experimental Therapeutics

    Kashiwa-shi,
    Japan

    Active - Recruiting

  • Cancer Institute Hospital of JFCR

    Koto-ku,
    Japan

    Active - Recruiting

  • NHO Kumamoto Medical Center - Dept of Urology

    Kumamoto-shi,
    Japan

    Active - Recruiting

  • Asan Medical Center

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital, Yonsei University Health System - Division of Infectious Diseases

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Hospital HM Nou Delfos - START Barcelona

    Barcelona,
    Spain

    Active - Recruiting

  • Hospital Universitari Vall d'Hebron - Oncology Dept.

    Barcelona,
    Spain

    Active - Recruiting

  • ICO l'Hospitalet - Hospital Duran i Reynals - Servicio de Oncologia

    Barcelona,
    Spain

    Active - Recruiting

  • Centro Integral Oncologico Clara Campal - Unidad de Fase I-Oncologica

    Madrid,
    Spain

    Active - Recruiting

  • Hospital Universitario 12 de Octubre - Servicio de Oncologia

    Madrid,
    Spain

    Active - Recruiting

  • Hospital Universitario Fundacion Jimenez Diaz - START Madrid FJD - Oncology Phase I

    Madrid,
    Spain

    Active - Recruiting

  • NEXT Madrid - Hospital Universitario Quironsalud Madrid

    Pozuelo de Alarcon,
    Spain

    Active - Recruiting

  • Please Contact U.S. Medical Information

    Rockland, Massachusetts 02370
    United States

    Site Not Available

  • NEXT Oncology - PARENT

    New York, New York 10065
    United States

    Active - Recruiting

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

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