M9466 as Single Agent or in Combination With Tuvusertib in Advanced Solid Tumors (DDRiver 501)
- Conditions
- Advanced Solid Tumor
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Module 1 Part A1 and Module 2 Part A1: Locally advanced or metastatic disease that<br> is refractory to standard therapy or for which no standard therapy is judged<br> appropriate by the Investigator<br><br> - Eastern Cooperative Oncology Group Performance Status less than or equal to (<=) 1<br><br> - Life expectancy of more than 6 months<br><br> - Have adequate hematologic function<br><br> - Participants who received chemotherapy, extensive radiotherapy, biological therapy<br> (e.g. antibodies) or investigational agents will have a washout period of 4 weeks (6<br> weeks for nitrosourea, mitomycin-C) or 5 half-lives whichever is shorter, prior to<br> starting study intervention with M9466 (± tuvusertib)<br><br> - Other protocol defined inclusion criteria could apply<br><br>Exclusion Criteria:<br><br> - Persistence of Adverse Events related to any prior treatments that have not<br> recovered to Grade less than 1 by NCI Common Terminology Criteria for Adverse<br> Events- v5.0 unless AEs are clinically nonsignificant and/or stable on supportive<br> therapy in the opinion of the Investigator (e.g. neuropathy or alopecia)<br><br> - Participant has a history of malignancy within 5 years before the date of enrollment<br> (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ<br> of the cervix, benign prostate neoplasm/hypertropia, or malignancy that in the<br> opinion of the Investigator, with concurrence of the Sponsor's Medical Monitor, is<br> considered cured with minimal risk of recurrence within 3 years)<br><br> - Participants with known brain metastases, except if clinically controlled, which is<br> defined as individuals with Central Nervous System (CNS) tumors that have been<br> treated, are asymptomatic and who have discontinued steroids (for the treatment of<br> CNS tumors) for more than 28 days<br><br> - Serious Gastrointestinal bleeding within 3 months, refractory nausea and vomiting,<br> uncontrolled diarrhea, known malabsorption, significant small bowel resection or<br> gastric bypass surgery, use of feeding tubes, other chronic gastrointestinal disease<br> (including exocrine pancreatic insufficiency requiring pancreatic enzyme replacement<br> therapy), and/or other situations that may preclude adequate absorption of oral<br> medications<br><br> - Cerebrovascular accident or stroke<br><br> - Other protocol defined exclusion criteria could apply
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Module 1 Part A1: Number of Participants With Treatment-Emergent Adverse Events (TEAE), and Treatment-related AEs;Module 1 Part A1: Number of Participants with Dose Limiting Toxicity (DLT)-like events;Module 2 Part A1: Pharmacokinetic (PK) Plasma Concentrations of M9466
- Secondary Outcome Measures
Name Time Method Module 1 Part A1: Pharmacokinetic (PK) Plasma Concentrations of M9466 and Tuvusertib;Module 1 Part A1: Objective Response (OR) According to Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 as Assessed by Investigator;Module 1 Part A1: Effect of M9466 in combination with tuvusertib on QTc interval as determined by Digital ECGs;Module 2 Part A1: Number of Participants With Treatment-Emergent Adverse Events (TEAE), and Treatment-Related AEs;Module 2 Part A1: Number of Participants with Abnormalities in Digital Electrocardiogram (ECG) Measures;Module 2 Part A1: Pharmacokinetic (PK) Plasma Concentrations of M9466 and Tuvusertib;Module 2 Part A1: Relative Changes in Pharmacodynamic Markers In Paired Tumor Biopsies