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NCT04170153 · ClinicalTrials.gov registry record · Phase 1
Tuvusertib (M1774) in Participants With Metastatic or Locally Advanced Unresectable Solid Tumors (DDRiver Solid Tumors 301)
A Phase 1 study of Metastatic or Locally Advanced Unresectable Solid Tumors, sponsored by EMD Serono Research & Development Institute.
- Active
- Registry status
- Phase 1
- Development phase
- 161
- Enrollment target
- 16
- Study locations
NCT04170153: Active Phase 1 study of Metastatic or Locally Advanced Unresectable Solid Tumors, sponsored by EMD Serono Research & Development Institute.
NCT04170153 is a Phase 1 study of Metastatic or Locally Advanced Unresectable Solid Tumors that is active but no longer recruiting, run by EMD Serono Research & Development Institute. The registered enrollment target is 161 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (168% higher). The trial reports 16 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04170153, a Phase 1 study of Metastatic or Locally Advanced Unresectable Solid Tumors, is active but no longer recruiting, sponsored by EMD Serono Research & Development Institute.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 161 participants
- Enrollment target
- 16
- Study locations
Study 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 Studied
Interventions
- DRUG Niraparib
- DRUG M1774
Study Locations (16)
Other
- 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
Texas
- NEXT Oncology - Austin
- Mary Crowley Cancer Research Centers - Dallas
- The Methodist Hospital Research Institute - Houston
- University of Texas M. D. Anderson Cancer Center - Investigational Cancer Therapeutics - Houston
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 161 participants |
| Start Date | 2019-12-20 |
| Est. Completion | 2027-01-30 |
| Phase | Phase 1 |
What the registry record for NCT04170153 still lists
NCT04170153 is an interventional study that assigns participants to a tested intervention. The registered 161 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (168% higher).
The record links to 1 condition, with Metastatic or Locally Advanced Unresectable Solid Tumors appearing as the primary indexed condition, and to 2 interventions - of which Niraparib is the first listed.
NCT04170153 lists 16 locations in 3 states (Other, Texas, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT04170153 about?
NCT04170153 is a clinical study titled "Tuvusertib (M1774) in Participants With Metastatic or Locally Advanced Unresectable Solid Tumors (DDRiver Solid Tumors 301)". 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 comb...
What is the current status of trial NCT04170153?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 161 participants. The study started on 2019-12-20. Estimated completion is 2027-01-30.
What conditions does trial NCT04170153 study?
This clinical trial studies the following conditions: Metastatic or Locally Advanced Unresectable Solid Tumors.
What interventions are being tested in trial NCT04170153?
The interventions under investigation include: Niraparib (DRUG), M1774 (DRUG).
Who is sponsoring clinical trial NCT04170153?
This trial is sponsored by EMD Serono Research & Development Institute, which has 81 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04170153 being conducted?
This trial has 16 study locations across Massachusetts, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04170153's enrollment target sits among peer trials
161 340th of 2000 higher than 1,661 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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