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Tuvusertib (M1774) in Participants With Metastatic or Locally Advanced Unresectable Solid Tumors (DDRiver Solid Tumors 301) | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1

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)

NCT04170153•EMD Serono Research & Development Institute, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participants with locally advanced or metastatic disease that is refractory to standard therapy or for which no standard therapy is judged appropriate by the Investigator which may convey clinical benefit
•Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to (\<=) 1
•Participants with clinically controlled brain metastases, which is defined as individuals with central nervous system metastases that have been treated for, are asymptomatic, and have discontinued steroids (for the treatment of brain metastases) for greater than (\>) 28 days may be enrolled
•Participants with meningeal carcinomatosis are excluded
•In Part A3, measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
•Part A3: Participants with presence of loss of function mutations in the genes for ARID1A, ATRX and /or DAXX and ATM
•Contraceptive use by males or females will be consistent with local regulations on contraception methods for those participating in clinical studies
•Adequate hematological, hepatic, and renal function as defined in the protocol
•Female participants are not pregnant or breastfeeding
•Part B1:
+9 more criteria

Exclusion Criteria

•Participants with major surgery (as deemed by the Investigator) for any reason, except diagnostic biopsy, within 4 weeks of the study intervention and/or if the participant has not fully recovered from the surgery within 4 weeks of the study intervention
•Presence of toxicities due to prior anticancer therapies (example, radiotherapy, chemotherapy, immunotherapies, et cetera \[etc\]) that do not recover to \<= Grade 1 with the exception of toxicities that do not pose a safety risk to the participant in the judgment of the Investigator (example: ongoing Grade 2 alopecia)
•Part B1 only: Uncontrolled arterial hypertension which is systolic blood pressure \>140 millimeter of mercury (mmHg); Diastolic blood pressure \>90mmHg
•Unstable angina, myocardial infarction, congestive heart failure \>= II or a coronary revascularization procedure within 180 days of study entry. Calculated QTc average (using the Fridericia correction calculation) of \> 450 msec for males and \> 470 msec for females that does not resolve with correction of electrolyte abnormalities
•Participants with active and/or uncontrolled infection. The following exceptions apply:

Locations (16)

Massachusetts General Hospital

Boston, Massachusetts, United States

NEXT Oncology

Austin, Texas, United States

Mary Crowley Cancer Research Centers

Dallas, Texas, United States

The Methodist Hospital Research Institute

Houston, Texas, United States

University of Texas M. D. Anderson Cancer Center - Investigational Cancer Therapeutics

Houston, Texas, United States

Beijing Cancer Hospital

Beijing, China

National Cancer Center Hospital - Dept of Experimental Therapeutics

Chūōku, Japan

National Cancer Center Hospital East - Dept of Experimental Therapeutics

Kashiwa-shi, Japan

Hospital Clinic de Barcelona - Servicio de Oncologia

Barcelona, Spain

Hospital Universitari Vall d'Hebron - Oncology Dept.

Barcelona, Spain

Key Dates

Start Date

December 20, 2019

Primary Completion Date

January 30, 2027

Completion Date

January 30, 2027

Last Updated

January 30, 2026

Enrollment

161

ACTUAL participants

Conditions

Metastatic or Locally Advanced Unresectable Solid Tumors

Interventions

M1774

DRUG

Niraparib

DRUG

First in Human Study of M1069 in Advanced Solid Tumors

NCT05198349

Metastatic or Locally Advanced Unresectable Solid Tumors

View study

TERMINATEDPHASE1

First-in-Human Study of MS201408-0005A as Single Agent and in Combinations

NCT03306420

Metastatic or Locally Advanced Unresectable Solid Tumors

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 30, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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