Advanced Solid Tumor
Conditions
Interventions
Experimental: M9466 + Irinotecan (Run-in Cohort)
Drug: M9466
-M9466 will be administered orally until progressive disease, unacceptable toxicity, death, or end of study.
-Other Names: HRS-1167
Drug: I
Sponsors
Uemura Chie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -M9466 + Irinotecan Run-in Cohort: 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 (that is [i.e.] participants who have exhausted all standard of care (SoC) options according to International Guidelines), and who may derive clinical benefit from the combination treatment with M9466 and irinotecan -M9466 + FOLFIRI + Bevacizumab Dose Finding Cohorts: Participants with documented histopathological diagnosis of locally advanced or metastatic colorectal cancer (CRC), who were intolerant/refractory to or progressed after standard systemic therapies for the advanced/metastatic stage that included: Oxaliplatin and a fluoropyrimidine (administration in the adjuvant setting fulfills this criterion if progression occurred within 12 months of the last dose). Prior use of irinotecan is permitted; Either an anti- epidermal growth factor receptor (anti-EGFR) or an anti- Vascular endothelial growth factor (anti-VEGF) agent (not applicable if oxaliplatin was administered in the adjuvant setting); An immune checkpoint inhibitor for participants with known MSI-H status; Cetuximab and encorafenib +- binimetinib, if locally available, for participants with BRAF V600E mutations. Participants may have received maximally 1 previous regimen for the treatment of metastatic disease (with the exception of participants with MSI-H disease or BRAF positive disease who are allowed to have had up to 2 previous lines of treatment) -Eastern Cooperative Oncology Group performance status (ECOG PS) less than or equal to (<=) 1 -Other protocol defined inclusion criteria could apply
Exclusion criteria
Exclusion criteria: -Persistence of AEs related to any prior treatments that have not recovered to Grade 28 days prior to first dose of study intervention -Other protocol defined exclusion criteria could apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Treatment Related TEAEs -Number of Participants with Dose Limiting Toxicity (DLT) | — |
Countries
Australia, Japan, Korea, Spain, USA
Contacts
Public ContactContact for Clinical Trial Information
Merck Biopharma Co., Ltd.
Outcome results
None listed