Active — Not RecruitingPhase 1

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

United States161 participantsStarted 2019-12-20

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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: Subpart B1a: Participants with Baseline Body weight \< 77 kg or platelets \<150,000 cubic per millimeter (mm\^3) Subpart B1b: Participants with Baseline Body weight \>= 77 kg and platelets \>=150,000 mm\^3 will be included \- Other protocol defined inclusion criteria could apply Exclusion Crit…

What they're measuring

Part A1, A4 and A5: Occurrence of Dose-Limiting Toxicities (DLTs) During the DLT Observation Period

Timeframe: Day 1 to Day 21 of Cycle 1 (Each Cycle is of 21 days)

Part A1, A3, A4, A5 and B1: Occurrence of Treatment-emergent Adverse Events (TEAEs), Treatment-related Adverse Events (AEs) and Death According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0

Timeframe: Baseline up to 30 days after the last dose of study treatment, assessed up to approximately 2.2 years

Part A1, A3, A4, A5 and B1: Number of Participants With Grade 3 or Higher Laboratory Findings According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0

Timeframe: Baseline up to 30 days after the last dose of study treatment, assessed up to approximately 2.2 years

Part A1, A3, A4, A5 and B1: Number of Participants With Abnormalities in Vital Signs

Timeframe: Baseline up to 30 days after the last dose of study treatment, assessed up to approximately 2.2 years

Part A1, A3, A4, A5 and B1: Number of Participants With Clinical Significant Abnormalities in Electrocardiogram (ECG) Findings

Timeframe: Baseline up to 30 days after the last dose of study treatment, assessed up to approximately 2.2 years

Part A2: Area Under the Plasma Concentration Curve From Time Zero to 24 Hours Post Dose (AUC 0-24h) of Tuvusertib (M1774)

Trial details

NCT IDNCT04170153

SponsorEMD Serono Research & Development Institute, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-07-30

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