Study of Tuvusertib (M1774) in Combination With DNA Damage Response Inhibitor or Immune Checkpoint Inhibitor (DDRiver Solid Tumors 320) (NCT05396833)
An Open-label, Multicenter Phase Ib Study of the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Profile of the ATR Inhibitor Tuvusertib (M1774) in Combination With DNA Damage Response Inhibitors or Immune Checkpoint Inhibitors in Patients With Metastatic or Locally Advanced Unresectable Solid Tumors (DDRiver Solid Tumors 320)
🩺 Plain-English Summary (8th-Grade Level)
This is an open-label, multicenter, clinical study conducted in multiple parts to establish the safety, tolerability, Pharmacokinetic/Pharmacodynamic (PK/PD) profile, maximum tolerated dose (MTD) combinations (if observed) and recommended dose for expansion (RDE) combination for tuvusertib in combination with lartesertib (in Part A1), food effect on the PK of lartesertib as monotherapy followed by treatment with tuvusertib in combination with lartesertib in participants with specific tumor types (in Part A1.1), relative bioavailability of a tuvusertib tablet formulation vs capsule formulation followed by treatment with tuvusertib (capsule) in combination with lartesertib in participants with specific tumor types (in Part A1.2), safety/tolerability and early signs of clinical activity of tuvusertib (capsule)and lartesertib in combination in participants with prostate cancer harboring loss of function (LoS) mutation in the gene ATM based on historic data collected prior to prescreening in circulating tumor (ct) DNA (liquid biopsies) or tumor biopsies (in Part A2), safety/tolerability and early signs of clinical activity of tuvusertib and lartesertib in combination in participants with endometrial cancer harboring LoS mutation(s) in the gene ARID1A based on historic data collected prior to prescreening in ctDNA (liquid biopsies) or tumor biopsies (in Part A3), the relative bioavailability of a tuvusertib tablet formulation (TF1, test) compared to a capsule formulation (reference) will also be investigated (in Part A2/A3), and identify a potential set of MTD combinations, and establish the RDE for the combination of tuvusertib and avelumab in participants with metastatic or locally advanced unresectable solid tumors (in Part B1).
Who can join: Review the eligibility criteria below.
Location: Providence Medical Foundation — Santa Rosa, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (22 Sites)
- Providence Medical Foundation — Santa Rosa, California
- University of Miami School of Medicine — Miami, Florida
- Augusta University - formerly Georgia Regents University — Augusta, Georgia
- The University of Kansas Medical Center Research Institute, Inc. — Kansas City, Kansas
- Carolina Urologic Research Center — Myrtle Beach, South Carolina
- Mary Crowley Cancer Research Centers — Dallas, Texas
- University of Texas M. D. Anderson Cancer Center - Partner — Houston, Texas
- NEXT Oncology — San Antonio, Texas
- Royal North Shore Hospital — St Leonards,
- Calvary Mater Newcastle - PARENT — Waratah,
- Princess Margaret Cancer Centre — Toronto,
- Seoul National University Bundang Hospital — Seongnam-si,
- Severance Hospital, Yonsei University Health System - Division of Infectious Diseases — Seoul,
- Asan Medical Center — Seoul,
- Samsung Medical Center — Seoul,
- The Catholic University of Korea, Seoul St. Mary's Hospital — Seoul,
- Korea University Guro Hospital — Seoul,
- Hospital QuironSalud Barcelona - Next Oncology — Barcelona,
- Hospital Clinic de Barcelona - Servicio de Oncologia — Barcelona,
- Centro Integral Oncologico Clara Campal - Unidad de Fase I-Oncologica — Madrid,
- Hospital Universitario Quironsalud Madrid - NEXT Oncology — Madrid,
- Hospital Universitario Fundacion Jimenez Diaz - START Madrid FJD - Oncology Phase I — Madrid,
💰 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.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.