AK112 plus chemotherapy versus bevacizumab plus chemotherapy for first-line metastatic colorectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase III, randomized comparison of AK112 combined with standard chemotherapy regimens versus bevacizumab combined with the same chemotherapy in adults with previously untreated metastatic colorectal adenocarcinoma. Eligible participants must have measurable disease by RECIST v1.1, ECOG 0-1, be aged 18–75, and have had no prior systemic therapy in the metastatic setting (prior adjuvant therapy allowed if relapse occurred ≥12 months after last dose). Treatments include AK112 or bevacizumab given alongside oxaliplatin- or irinotecan-based regimens with leucovorin and 5-FU, with planned follow-up for safety and tumor response. The trial will monitor efficacy and adverse events to determine whether AK112 offers better outcomes than the current bevacizumab-containing standard.

Why it matters

Who can join: the full rules

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.

Where it's running

• The Sixth Hospital,Sun Yat-sen University
  Guanzhou, Guangdong, China Recruiting
• Sun Yat-sen University Cancer Center
  Guanzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Xufang Yu, MD
• Email: clincialtrails@akesobio.com
• Phone: +86(0760)89873999

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.