A Phase III, Randomized, Controlled and Multi-center Study of AK112 and Chemotherapy in First-line Metastatic Colorectal Cancer

Launched by AKESO · Apr 23, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment option for patients with metastatic colorectal cancer, which is a type of cancer that has spread beyond the colon. Specifically, the trial is comparing a medication called AK112 combined with chemotherapy to another treatment called bevacizumab along with chemotherapy. The goal is to see which combination is more effective and safe for patients starting treatment for the first time.

To be eligible for this trial, participants must be between 18 and 75 years old and have a confirmed diagnosis of metastatic colorectal adenocarcinoma. They should not have received any prior treatment for this stage of cancer and must have at least one measurable tumor. Patients can expect to be monitored closely throughout the study, and they will need to agree to use effective contraception if they are of childbearing age. It’s important to know that the trial is not yet recruiting participants, so it’s a future opportunity for those who meet the criteria.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Signed informed consent.
• • 2. Age ≥ 18 years and ≤ 75 years.
• • 3. ECOG status of 0 or 1.
• • 4. Estimated survival ≥ 3 months.
• • 5. Subjects with histologically or cytologically confirmed metastatic colorectal adenocarcinoma.
• • 6. Subjects who are not candidates for radical surgical resection or local therapy and have not received systemic anti-tumor therapy in the recurrent or metastatic setting. Subjects who have received prior neoadjuvant or adjuvant therapy and whose first discovery of recurrence or metastases is ≥ 12 months after the last dose of neoadjuvant or adjuvant therapy are allowed to enroll.
• • 7. At least one measurable disease based on RECIST v1.1.
• • 8. Adequate organ function per protocol-defined criteria.
• • 9. Women of childbearing potential and men with female partners of childbearing potential must agree to use effective contraception during treatment and for at least 180 days following the last dose of study treatment.
• Exclusion Criteria:
• • 1. Previous (within 3 years) or concurrent other malignant tumors, excluding those that have been cured.
• • 2. Participating in other interventional study within 4 weeks prior to the first study drug administration.
• • 3. Palliative local treatment for non-target lesions within 2 weeks prior to the first administration; received non-specific immunomodulatory therapy within 2 weeks prior to the first administration.
• • 4. Current presence of uncontrolled combined disease.
• • 5. Active clinical infections.
• • 6. History of severe bleeding tendency or coagulation dysfunction.
• • 7. Subjects with known active tuberculosis (TB); suspected active TB should be excluded by clinical examination, known active syphilis infection.
• • 8. Received a live vaccine within 30 days prior to the study, or plan to receive a live vaccine during the study.
• • 9. Current presence of significant radiographic or clinical manifestations of GI obstruction.
• • 10. Toxicities of prior anticancer therapy have not resolved to ≤ Grade 1 (NCI-CTCAE version 5.0).
• • 11. Pregnant or lactating women.
• • 12. Any condition considered by the investigator to be inappropriate for enrollment.
• • 13. Local or systemic disease caused by non-malignancy, or disease or symptom secondary to tumor, that can lead to higher medical risk and/or uncertainty in survival.