Colorectal Cancer
Conditions
Interventions
[M9140]
- Part 1: M9140 will be administered at an escalated dose until Maximum tolerated dose (MTD) and/or a safe recommended Dose for Expansion (RDE) is determined in Part 1 of the study.
- Part 2 :
Sponsors
Uemura Chie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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, if locally indicated and available to the participant. Participants with a known microsatellite instability high (MSI-H) status must have received treatment with an immune checkpoint inhibitor (if locally indicated and available) unless contraindicated. - Eastern Cooperative Oncology Group Performance Status (ECOG PS) below or equal to 1 - Participants with adequate hematologic, hepatic and renal function as defined in protocol - Other protocol defined inclusion criteria could apply
Exclusion criteria
Exclusion criteria: - Participant has a history of malignancy within 3 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 with the Sponsor's Medical Monitor, is considered cured with minimal risk of recurrence within 3 years) - Participants with known brain metastases, except those meeting the following criteria: Brain metastases that have been treated locally and are clinically stable for at least 4 weeks prior to the start of treatment; No ongoing neurological symptoms that are related to the brain localization of the disease (sequelae that are a consequence of the treatment of the brain metastases are acceptable) - Participants with diarrhea (liquid stool) or ileus Grade > 1 - Participants with active chronic inflammatory bowel disease (e.g., ulcerative colitis, Crohn's disease, intestinal perforation) and/or bowel obstruction - Unstable angina, myocardial infarction, congestive heart failure (New York Heart Association [NYHA] >= II) or a coronary revascularization procedure within 180 days of study entry. Calculated QTc average (using the Fridericia correction calculation) of > 470 milliseconds (ms) - Cerebrovascular accident/stroke (< 6 months prior to enrollment) - Other protocol defined exclusion criteria could apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1 - Number of Participants with Dose Limiting Toxicities (DLTs) and Adverse Events (AEs) [ Time Frame: up to 4 months ] - Recommended Dose Expansion (RDE) of M9140 [ Time Frame: up to 4 months ] Part 2 Part 2A: Number of Participants with Adverse Events (AEs)[Time Frame: up to 8 months], Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigators[Time Frame: Time from first study treatment throughout the study duration until progressive disease or death up to approximately 8 months], and Duration of Response (DoR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigators[Time Frame:Time from first study treatment to planned assessment at approximately 8 months] Parts 2B, 2C and 2D: Number of Participants with Dose Limiting Toxicities (DLTs) and Adverse Events (AEs) [Time Frame: up to 8 months] | — |
Countries
Canada, Japan, South Korea, Spain, USA
Contacts
Public ContactClinical Trial Information Contact
Merck Biopharma Co., Ltd.
Outcome results
None listed