🏛️ Verified NIH Record • Updated 2026-08-11

Tuvusertib (M1774) in Participants With Metastatic or Locally Advanced Unresectable Solid Tumors (DDRiver Solid Tumors 301) (NCT04170153)

An Open-label, Multicenter Trial of the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Profile of Tuvusertib (M1774) in Participants With Metastatic or Locally Advanced Unresectable Solid Tumors (DDRiver Solid Tumors 301)

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

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

This is an open-label, Phase I, first-in-human (FIH) multicenter, clinical study conducted in multiple parts to establish the safety, tolerability and pharmacokinetic/pharmacodynamic (PK/PD) profile (with and without food) and early signs of efficacy of Tuvuseritib (M1774) as monotherapy and in combination with the poly (ADP-ribose) polymerase (PARP) inhibitor niraparib.

Who can join: Review the eligibility criteria below.

Location: Massachusetts General Hospital — Boston, Massachusetts

Age range: 18 Years

🧪 Interventions in This Study

📋 "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 (16 Sites)

  • Massachusetts General Hospital — Boston, Massachusetts
  • NEXT Oncology — Austin, Texas
  • Mary Crowley Cancer Research Centers — Dallas, Texas
  • The Methodist Hospital Research Institute — Houston, Texas
  • University of Texas M. D. Anderson Cancer Center - Investigational Cancer Therapeutics — Houston, Texas
  • Beijing Cancer Hospital — Beijing,
  • National Cancer Center Hospital - Dept of Experimental Therapeutics — Chūōku,
  • National Cancer Center Hospital East - Dept of Experimental Therapeutics — Kashiwa-shi,
  • Hospital Clinic de Barcelona - Servicio de Oncologia — Barcelona,
  • Hospital Universitari Vall d'Hebron - Oncology Dept. — Barcelona,
  • Centro Integral Oncologico Clara Campal - Unidad de Fase I-Oncologica — Madrid,
  • Hospital Clinico Universitario de Valencia - Servicio de Hematologia y Oncologia Medica — Valencia,
  • Addenbrooke's Hospital - Dept of Oncology — Cambridge,
  • The Christie Hospital - Dept of Oncology — Manchester,
  • Northern Centre for Cancer Care - Sir Bobby Robson Cancer Trials Research Centre — Newcastle upon Tyne,
  • Royal Marsden Hospital - Dept of Oncology — Sutton,

💰 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.

More studies in Metastatic or Locally Advanced Unresectable Solid Tumors

💡 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 ↗