Status:
NOT_YET_RECRUITING
A Phase III, Randomized, Controlled and Multi-center Study of AK112 and Chemotherapy in First-line Metastatic Colorectal Cancer
Lead Sponsor:
Akeso
Conditions:
Colorectal Adenocarcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
This trial is a Phase III study. The purpose of this study is to evaluate the efficacy and safety of AK112 and chemotherapy versus bevacizumab and chemotherapy for the first-line treatment of metastat...
Eligibility Criteria
Inclusion
- Signed informed consent.
- Age ≥ 18 years and ≤ 75 years.
- ECOG status of 0 or 1.
- Estimated survival ≥ 3 months.
- Subjects with histologically or cytologically confirmed metastatic colorectal adenocarcinoma.
- 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.
- At least one measurable disease based on RECIST v1.1.
- Adequate organ function per protocol-defined criteria.
- 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
- Previous (within 3 years) or concurrent other malignant tumors, excluding those that have been cured.
- Participating in other interventional study within 4 weeks prior to the first study drug administration.
- 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.
- Current presence of uncontrolled combined disease.
- Active clinical infections.
- History of severe bleeding tendency or coagulation dysfunction.
- Subjects with known active tuberculosis (TB); suspected active TB should be excluded by clinical examination, known active syphilis infection.
- Received a live vaccine within 30 days prior to the study, or plan to receive a live vaccine during the study.
- Current presence of significant radiographic or clinical manifestations of GI obstruction.
- Toxicities of prior anticancer therapy have not resolved to ≤ Grade 1 (NCI-CTCAE version 5.0).
- Pregnant or lactating women.
- Any condition considered by the investigator to be inappropriate for enrollment.
- 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.
Key Trial Info
Start Date :
May 9 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 7 2029
Estimated Enrollment :
560 Patients enrolled
Trial Details
Trial ID
NCT06951503
Start Date
May 9 2025
End Date
January 7 2029
Last Update
April 30 2025
Active Locations (2)
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1
The Sixth Hospital,Sun Yat-sen University
Guanzhou, Guangdong, China, 510000
2
Sun Yat-sen University Cancer Center
Guanzhou, Guangdong, China