Clinical Trial

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

Active, Not Recruiting Phase 1
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Summary
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.
Protocol Amendment History 4 changes
notable Primary completion pushed: 2026-07-30 -> 2026-11-30 2026-08-14
minor Completion pushed: 2026-07-30 -> 2026-11-30 2026-08-14
notable Primary completion moved earlier: 2027-01-30 -> 2026-07-30 2026-05-08
minor Completion moved earlier: 2027-01-30 -> 2026-07-30 2026-05-08
Trial Details
NCT Number NCT04170153
Lead Sponsor EMD Serono Research & Development Institute, Inc.
Collaborators: Merck KGaA, Darmstadt, Germany
Conditions Metastatic or Locally Advanced Unresectable Solid Tumors
Enrollment 161 participants
Start Date 2019-12-20
Primary Completion 2026-11-30 (estimated)
Study Completion 2026-11-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-13