Evaluating M9140 for advanced colorectal cancer in Chinese patients
A Phase 1, Open-label Study of AntiCEACAM5 AntibodyDrug Conjugate M9140 in Chinese Participants With Solid Tumors (PROCEADE-CRC-02)
This study is testing a new drug called M9140 to see if it is safe and helps people with advanced colorectal cancer who haven't had success with standard treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany Industry-sponsored |
| Drugs / interventions | fruquintinib |
| Locations | 3 sites (Beijing and 2 other locations) |
| Trial ID | NCT06806046 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety and early clinical activity of the drug M9140 in Chinese participants diagnosed with locally advanced or metastatic colorectal cancer (CRC). It focuses on patients who have not responded to or are intolerant of standard systemic therapies. The trial will involve administering M9140 and monitoring its effects on the participants' condition. The study is in Phase 1, indicating it is in the early stages of evaluating the drug's safety and efficacy.
Who should consider this trial
Good fit: Ideal candidates for this study are Chinese patients with advanced or metastatic colorectal cancer who have not responded to standard therapies.
Not a fit: Patients with early-stage colorectal cancer or those who have not yet undergone standard systemic therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced colorectal cancer who have limited treatment choices.
How similar studies have performed: Other studies involving antibody-drug conjugates (ADCs) have shown promise in treating solid tumors, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Beijing and 2 other locations
- Beijing Cancer Hospital — Beijing, China (Recruiting)
- The Sixth Affiliated Hospital of Sun Yat-sen University — Guangzhou, China (Recruiting)
- The Second Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou, China (Recruiting)
Study contacts
- Study coordinator: Communication Center
- Email: service@emdgroup.com
- Phone: +49 6151 72 5200
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.