Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Tuvusertib (M1774) in Participants With Metastatic or Locally Advanced Unresectable Solid Tumors (DDRiver Solid Tumors 301)
NCT04170153 · View on ClinicalTrials.gov ↗
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 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04170153
The ClinicalTrials.gov registry entry for NCT04170153 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 161 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is EMD Serono Research & Development Institute, which has 51 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04170153 reports 16 study locations spanning 3 distinct geographic areas — top geographies include Other, Texas, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04170153?
The interventions under investigation include: Niraparib (DRUG), M1774 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04170153?
This trial is sponsored by EMD Serono Research & Development Institute, which has 51 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.