Comparing Precem-TcT (with or without bevacizumab) versus trifluridine/tipiracil plus bevacizumab for people with previously treated metastatic colorectal cancer
A Randomized, Open Label, 3-arm Phase 3 Study of Precemtabart Tocentecan With or Without Bevacizumab Compared to Trifluridine/Tipiracil Plus Bevacizumab in Participants With Previously Treated Metastatic Colorectal Cancer (PROCEADE-CRC-03)
This trial will see if Precem-TcT, alone or with bevacizumab, helps people with metastatic colorectal cancer who have already received standard chemotherapy, compared with trifluridine/tipiracil plus bevacizumab.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 1020 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | EMD Serono Industry-sponsored |
| Drugs / interventions | bevacizumab |
| Locations | 3 sites (Troy, Michigan and 2 other locations) |
| Trial ID | NCT07549412 on ClinicalTrials.gov |
What this trial studies
This is a phase 3, randomized, multicenter trial comparing precemtabart tocentecan (Precem-TcT), given either alone or together with bevacizumab, against trifluridine/tipiracil (FTD‑TPI) plus bevacizumab in participants with metastatic colorectal cancer who have progressed after prior standard therapies. Participants must have received prior irinotecan, oxaliplatin, a fluoropyrimidine, and bevacizumab and have ECOG performance status 0–1. The primary goal is to demonstrate an overall survival benefit for Precem-TcT-containing regimens; secondary endpoints include safety and other efficacy measures. The trial is sponsored by EMD Serono with collaboration from Merck KGaA and is open at sites in the United States and Australia.
Who should consider this trial
Good fit: Ideal candidates are adults with histologically confirmed metastatic colorectal cancer who progressed on or were intolerant to standard regimens (including irinotecan, oxaliplatin, a fluoropyrimidine, and bevacizumab), have received no more than two prior metastatic regimens, and have ECOG performance status 0–1.
Not a fit: Patients with unresolved high-grade toxicities from prior therapy, a recent additional malignancy, poor performance status (ECOG >1), or who cannot take oral tablets would likely not benefit or be ineligible for this trial.
Why it matters
Potential benefit: If successful, this approach could extend overall survival for people with metastatic colorectal cancer who have exhausted standard chemotherapy options.
How similar studies have performed: Antibody–drug conjugates with topoisomerase I–related payloads have shown promising results in some cancers, but CEACAM5-directed ADCs in later-line metastatic colorectal cancer remain relatively new with limited phase 3 evidence to date.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants with documented histopathological diagnosis of metastatic colorectal cancer, who were intolerant to, or whose disease was refractory to, or progressed after standard systemic therapies and no more than 2 previous systemic treatment regimens in the metastatic setting. * Participants must have received and progressed on no more than 2 previous systemic treatment regimens in the metastatic setting * Eastern Cooperative Oncology Group (ECOG) performance status less than equal to 1 * Participants must be able to swallow oral tablets, and to comply with the study requirements for all scheduled evaluations * Other protocol defined inclusion criteria may apply Exclusion Criteria: * If Adverse Events related to previous therapies have not recovered to less than Grade 1 by National Cancer Institute - Common Terminology Criteria for Adverse Events version 6.0 * Participant has a history of additional malignancy within 3 years before randomization * Participants with known brain metastases * Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months prior to randomization * Participants with ileus of more than Grade 1, or chronic inflammatory bowel disease (example ulcerative colitis, Crohn's disease) and/or bowel obstruction, or participants with chronic gastrointestinal disorders that, in the Investigator's opinion, might significantly interfere with proper absorption of the study treatments * Other protocol defined exclusion criteria may apply
Where this trial is running
Troy, Michigan and 2 other locations
- Profound Research LLC at Cancer and Leukemia Center — Troy, Michigan, United States (Recruiting)
- GenesisCare North Shore (Oncology) — St Leonards, New South Wales, Australia (Recruiting)
- Icon Cancer Centre Chermside — Chermside, Queensland, Australia (Recruiting)
Study contacts
- Study coordinator: US Medical Information
- Email: eMediUSA@emdserono.com
- Phone: 888-275-7376
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.