NCT04170153

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

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)

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 161 (actual)
• Sponsor: EMD Serono Research & Development Institute, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic or Locally Advanced Unresectable Solid Tumors

Interventions

Type	Name	Description
DRUG	M1774	M1774 will be administered orally throughout the study.
DRUG	Niraparib	Niraparib will be administered orally throughout the study.

Timeline

• Start date: 2019-12-20
• Primary completion: 2027-01-30
• Completion: 2027-01-30
• First posted: 2019-11-20
• Last updated: 2026-01-30

Locations

16 sites across 5 countries: United States, China, Japan, Spain, United Kingdom

Regulatory

• FDA-regulated drug study