🏛️ Verified NIH Record • Updated 2026-06-25

M9466 Alone or in Combination in Advanced Solid Tumors (DDriver 501) (NCT06421935)

An Open Label, Multicenter, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Profile of the PARP1 Inhibitor M9466 Alone or in Combination in Participants With Advanced Solid Tumors

🔵 Active, Not Recruiting Phase1 💊 Investigational Drug / Biologic Sponsor: EMD Serono Research & Development Institute, Inc.

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: NEXT Oncology - PARENT — New York, New York

Age range: 18 Years

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (20 Sites)

  • NEXT Oncology - PARENT — New York, New York
  • The University of Texas MD Anderson Cancer Center — Houston, Texas
  • 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,

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗