Anti-CEACAM5 ADC M9140 in Chinese Participants With Solid Tumors (PROCEADE-CRC-02)

Launched by MERCK HEALTHCARE KGAA, DARMSTADT, GERMANY, AN AFFILIATE OF MERCK KGAA, DARMSTADT, GERMANY · Jan 29, 2025

Keywords

ClinConnect Summary

This clinical trial, called PROCEADE-CRC-02, is studying a new treatment called M9140 for Chinese participants who have advanced or metastatic colorectal cancer (CRC). The main goal of the trial is to check how safe this new treatment is and to see if it works well in patients who have already tried other standard therapies that didn’t help. To participate, patients need to have a confirmed diagnosis of locally advanced or metastatic CRC and must have tried standard treatments like chemotherapy but did not respond or could not tolerate them.

Participants in this study can expect to undergo various assessments to ensure they are healthy enough to receive the new treatment. They will need to be between the ages of 65 and 74 and meet specific health criteria, such as having good overall health and stable blood counts and organ function. This trial is currently recruiting participants, and it’s important for interested individuals to discuss the details with their healthcare provider to understand if they meet the eligibility requirements and what being part of the study will involve.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Participants with documented histopathological diagnosis of locally advanced or metastatic CRC, who were intolerant/refractory to or progressed after standard systemic therapies for the advanced/metastatic stage that included and are restricted to a fluoropyrimidine, irinotecan, a platinum agent (e.g. oxaliplatin), an anti-EGFR agent (if clinically indicated, i.e. RAS/BRAF wt), and an anti-VEGF agent. Participants may have received previous treatment with trifluridine/tipiracil and/or regorafenib or fruquintinib, if locally indicated and available. Participants with a known 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:
• • 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
• • Cerebrovascular accident/stroke (\< 6 months prior to enrollment)
• • Other protocol defined exclusion criteria could apply