Anti-CEACAM5 ADC M9140 in Advanced Solid Tumors (PROCEADE-CRC-01)

Launched by EMD SERONO RESEARCH & DEVELOPMENT INSTITUTE, INC. · Jul 15, 2022

Keywords

ClinConnect Summary

The clinical trial named PROCEADE-CRC-01 is studying a new treatment called M9140 for patients with advanced colorectal cancer, which is a type of cancer that starts in the colon or rectum. This is the first time M9140 is being tested in humans, and the main goals are to see how safe it is, how well it is tolerated, and if it shows any signs of effectiveness. The study has two parts: the first part will gradually increase the dose to find the right amount to give, while the second part will focus on giving that dose to more patients to gather more information.

To be eligible for this trial, participants need to have advanced colorectal cancer that has not responded to standard treatments. They should also be in relatively good health, meaning they can perform daily activities without major difficulty. Participants can expect to be involved in the trial for about four months during the first part and up to eight months during the second part. It's important to note that this treatment is not available to the public outside of this study, and specific health conditions may prevent some people from participating.

Gender

ALL

Eligibility 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:
• • 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