Anti-CEACAM5 ADC M9140 in Advanced Solid Tumors

Phase 1

Recruiting

• Conditions: Colorectal Cancer

• Registration Number: JPRN-jRCT2031220313
• Lead Sponsor: Sasazaki Daisuke

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-09-02
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 5

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) less than (<=) 1
- Participants with adequate hematologic, hepatic and renal function as defined in protocol
- Other protocol defined inclusion criteria could apply

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- Number of Participants with Dose Limiting Toxicities (DLTs) and Adverse Events (AEs) [ Time Frame: up to 4 months ]<br>- Recommended Dose Expansion (RDE) of M9140 [ Time Frame: up to 4 months ]