M9466 as Single Agent or in Combination with Tuvusertib in Advanced Solid Tumors

JRCT ID: jRCT2031240255

Registered date:06/08/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Advanced Solid Tumors
• Date of first enrollment: 06/08/2024
• Target sample size: 13
• Countries of recruitment: USA,Japan,Korea,Japan,Spain,Japan,UK,Japan
• Study type: Interventional

Intervention(s)

Drug: M9466
Participants will be administered M9466 orally.
Drug: Tuvusertib
Participants will be administered Tuvusertib orally.

Outcome(s)

Primary Outcome

- 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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- Module 1 Part A1 and Module 2 Part A1: Locally advanced or metastatic disease that is refractory to standard therapy or for which no standard therapy is judged appropriate by the Investigator
- Eastern Cooperative Oncology Group Performance Status less than or equal to (<=) 1
- Life expectancy of more than 6 months
- Have adequate hematologic function
- Participants who received chemotherapy, extensive radiotherapy, biological therapy (e.g. antibodies) or investigational agents will have a washout period of 4 weeks (6 weeks for nitrosourea, mitomycin-C) or 5 half-lives whichever is shorter, prior to starting study intervention with M9466 (+- tuvusertib)
- Other protocol defined inclusion criteria could apply

Exclude criteria

- Persistence of Adverse Events related to any prior treatments that have not recovered to Grade less than 1 by NCI Common Terminology Criteria for Adverse Events- v5.0 unless AEs are clinically nonsignificant and/or stable on supportive therapy in the opinion of the Investigator (e.g. neuropathy or alopecia)
- Participant has a history of malignancy within 5 years before the date of enrollment (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, benign prostate neoplasm/hypertropia, or malignancy that in the opinion of the Investigator, with concurrence of the Sponsor's Medical Monitor, is considered cured with minimal risk of recurrence within 3 years)
- Participants with known brain metastases, except if clinically controlled, which is defined as individuals with Central Nervous System (CNS) tumors that have been treated, are asymptomatic and who have discontinued steroids (for the treatment of CNS tumors) for more than 28 days
- Serious Gastrointestinal bleeding within 3 months, refractory nausea and vomiting, uncontrolled diarrhea, known malabsorption, significant small bowel resection or gastric bypass surgery, use of feeding tubes, other chronic gastrointestinal disease (including exocrine pancreatic insufficiency requiring pancreatic enzyme replacement therapy), and/or other situations that may preclude adequate absorption of oral medications
- Cerebrovascular accident or stroke
- Other protocol defined exclusion criteria could apply

Related Information

• Primary Sponsor: Ishii Kyoko
• Secondary ID(s): NCT06421935