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ACTIVE NOT RECRUITING Phase 1

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

NCT06421935 · View on ClinicalTrials.gov ↗

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 Studied

Interventions

  • DRUG Abiraterone acetate
  • DRUG M9466
  • DRUG Tuvusertib
  • DRUG Prednisone/Prednisolone

Study Locations (20)

Other

  • Cancer Research SA — Adelaide
  • GenesisCare North Shore (Oncology) — St Leonards
  • Harasanshin Hospital — Fukuoka
  • National Cancer Center Hospital East - Dept of Experimental Therapeutics — Kashiwa-shi
  • Cancer Institute Hospital of JFCR — Kōtoku
  • NHO Kumamoto Medical Center - Dept of Urology — Kumamoto
  • Seoul National University Bundang Hospital — Seongnam
  • Asan Medical Center — Seoul
  • Samsung Medical Center — Seoul
  • Seoul National University Hospital — Seoul
  • Severance Hospital, Yonsei University Health System - Division of Infectious Diseases — Seoul
  • Hospital HM Nou Delfos - START Barcelona — Barcelona
  • Hospital Universitari Vall d'Hebron - Oncology Dept. — Barcelona
  • ICO l'Hospitalet - Hospital Duran i Reynals - Servicio de Oncologia — Barcelona
  • Centro Integral Oncologico Clara Campal - Unidad de Fase I-Oncologica — Madrid
  • Hospital Universitario 12 de Octubre - Servicio de Oncologia — Madrid
  • Hospital Universitario Fundacion Jimenez Diaz - START Madrid FJD - Oncology Phase I — Madrid
  • NEXT Madrid - Hospital Universitario Quironsalud Madrid — Pozuelo de Alarcón

New York

  • NEXT Oncology - PARENT — New York

Texas

  • The University of Texas MD Anderson Cancer Center — Houston

Trial Details

FieldValue
Enrollment Target 141 participants
Start Date 2024-08-07
Est. Completion 2027-02-22
Phase Phase 1

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06421935

The ClinicalTrials.gov registry entry for NCT06421935 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 141 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is EMD Serono Research & Development Institute, which has 51 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Advanced Solid Tumor appearing as the primary indexed condition, and to 4 interventions — of which Abiraterone acetate is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06421935 reports 20 study locations spanning 3 distinct geographic areas — top geographies include Other, New York, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06421935 about?

NCT06421935 is a clinical study titled "M9466 Alone or in Combination in Advanced Solid Tumors (DDriver 501)". 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...

What is the current status of trial NCT06421935?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 141 participants. The study started on 2024-08-07. Estimated completion is 2027-02-22.

What conditions does trial NCT06421935 study?

This clinical trial studies the following conditions: Advanced Solid Tumor. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06421935?

The interventions under investigation include: Abiraterone acetate (DRUG), M9466 (DRUG), Tuvusertib (DRUG), Prednisone/Prednisolone (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06421935?

This trial is sponsored by EMD Serono Research & Development Institute, which has 51 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06421935 being conducted?

This trial has 20 study locations across New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial