The BECOME trial will study whether becotatug vedotin combined with pucotenlimab can shrink tumors and how safe this treatment is in adults with colorectal cancer that has returned or spread after at least two prior lines of standard treatment. The study described in the informed consent form is for patients whose tumors test positive for a protein called epidermal growth factor receptor (EGFR).
Becotatug vedotin, also known as MRG003, is an antibody-drug conjugate (ADC). It combines an antibody that recognizes EGFR with a drug designed to kill cancer cells. Pucotenlimab is an immunotherapy that blocks a protein called PD-1 and may help the immune system recognize and attack cancer cells. The benefit and risks of using these two medicines together in this patient group are being investigated.
This study plans to enroll 31 participants at Fudan University Shanghai Cancer Center in China. All participants will receive the same combination treatment. There is no comparison group, and both participants and study doctors will know which medicines are being given. Participants must be at least 18 years old, have at least one tumor that can be measured on a scan, and have adequate organ function and physical fitness for treatment. Doctors will review medical history, examine participants, and perform tests to check eligibility before treatment begins.
Participants will receive both medicines through an intravenous infusion once every three weeks. Pucotenlimab will be given at 200 mg, and becotatug vedotin at 2.0 mg per kilogram of body weight. Treatment may continue for up to two years but may stop earlier if the cancer worsens, side effects become unacceptable, a participant withdraws consent, or another reason specified in the study plan occurs. Study doctors may pause treatment, adjust the dose where appropriate, or stop treatment for safety reasons.
Participants will attend regular visits for examinations, blood and urine tests, heart checks, and monitoring of side effects. Tumor scans will be performed every two treatment cycles during the first six cycles and every three months afterward. A safety follow-up will take place about 30 days after the last dose, followed by survival follow-up approximately every 12 weeks.
The main outcome is the proportion of participants whose tumors shrink or disappear on scans. Researchers will also assess how long responses last, how long participants live without their cancer worsening, overall survival, and side effects. Possible risks include low blood cell counts, skin reactions, liver test abnormalities, nerve problems, and infusion reactions. Other serious or unexpected side effects may occur. Benefit is not guaranteed. Participation is voluntary, and participants may withdraw without affecting their usual medical care.