Tuvusertib (M1774) in Participants With Metastatic or Locally Advanced Unresectable Solid Tumors (DDRiver Solid Tumors 301)
Condition(s) studied
Investigational drug(s) / intervention(s)
M1774: M1774 will be administered orally throughout the study.
Niraparib: Niraparib will be administered orally throughout the study.
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.
Eligibility
Primary outcome measure(s)
- Part A1, A4 and A5: Occurrence of Dose-Limiting Toxicities (DLTs) During the DLT Observation Period — 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 — 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 — 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 — 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 — 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) — Cycle 1 Day -7 and Day 1: Pre-dose up to 24 hours post-dose (Each Cycle is of 21 days)
- Part A2: Area Under the Plasma Concentration Curve From Time Zero to Infinity Post Dose (AUC 0-inf) of Tuvusertib (M1774) — Cycle 1 Day -7 and Day 1: Pre-dose up to 24 hours post-dose (Each Cycle is of 21 days)
- Part A2: Maximum Observed Plasma Concentration (Cmax) of Tuvusertib (M1774) — Cycle 1 Day -7 and Day 1: Pre-dose up to 24 hours post-dose (Each Cycle is of 21 days)
- Part A2: Relative Bioavailability Based on Area Under the Plasma Concentration Curve (Frel[AUC]) of Tuvusertib (M1774) Under Fed Condition as Compared to Fasting Condition — Cycle 1 Day -7 and Day 1: Pre-dose up to 24 hours post-dose (Each Cycle is of 21 days)
- Part A2: Relative Bioavailability Based on Maximum Observed Plasma Concentration (Frel[Cmax]) of Tuvusertib (M1774) Under Fed Condition as Compared to Fasting Condition — Cycle 1 Day -7 and Day 1: Pre-dose up to 24 hours post-dose (Each Cycle is of 21 days)
- Part A3: Objective Response as Assessed by Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 — Baseline up to 2.2 years
- Part B1: Occurrence of Dose-Limiting Toxicities (DLTs) During the DLT Observation Period — Day 1 to Day 28 of Cycle 1 (Each Cycle is of 28 days)
- Part A1, A4, A5 and B1: To Determine the Recommended Dose Expansion (RDE) for Tuvusertib (M1774) monotherapy globally, in Japanese and in Chinese participants With Metastatic or Locally Advanced Unresectable Solid Tumors and in combination with Niraparib — Assessed up to approximately 2.2 years
Trial sites (16)
| Facility | City | Region | Status |
|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | |
| NEXT Oncology | Austin | Texas | |
| Mary Crowley Cancer Research Centers | Dallas | Texas | |
| The Methodist Hospital Research Institute | Houston | Texas | |
| University of Texas M. D. Anderson Cancer Center - Investigational Cancer Therapeutics | Houston | Texas | |
| 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 | |
| Centro Integral Oncologico Clara Campal - Unidad de Fase I-Oncologica | Madrid | Spain | |
| Hospital Clinico Universitario de Valencia - Servicio de Hematologia y Oncologia Medica | Valencia | Spain | |
| Addenbrooke's Hospital - Dept of Oncology | Cambridge | United Kingdom | |
| The Christie Hospital - Dept of Oncology | Manchester | United Kingdom | |
| Northern Centre for Cancer Care - Sir Bobby Robson Cancer Trials Research Centre | Newcastle upon Tyne | United Kingdom | |
| Royal Marsden Hospital - Dept of Oncology | Sutton | United Kingdom |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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