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

NCT ID: NCT06951503

Last Updated: 2025-04-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 560 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-09
• Study Completion Date: 2029-01-07

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 metastatic colorectal cancer.

Conditions

Colorectal Adenocarcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

AK112 in combination with FOLFOXIRI

AK112 in combination with FOLFOXIRI (Irinotecan, Oxaliplatin, Leucovorin and 5-FU) for induction treatment. Later, patients will receive maintenance Leucovorin and 5-FU plus AK112.

Group Type: EXPERIMENTAL

AK112

Intervention Type: DRUG

iv, q2w

Oxaliplatin

Intervention Type: DRUG

iv, q2w

Irinotecan

Intervention Type: DRUG

iv, q2w

Leucovorin and 5-FU

Intervention Type: DRUG

iv, q2w

Bevacizumab in combination with FOLFOXIRI

Bevacizumab in combination with FOLFOXIRI (Irinotecan, Oxaliplatin, Leucovorin and 5-FU) for induction treatment. Later, patients will receive maintenance Leucovorin and 5-FU plus Bevacizumab .

Group Type: ACTIVE_COMPARATOR

Oxaliplatin

Intervention Type: DRUG

iv, q2w

Irinotecan

Intervention Type: DRUG

iv, q2w

Leucovorin and 5-FU

Intervention Type: DRUG

iv, q2w

Bevacizumab

Intervention Type: DRUG

iv, q2w

Interventions

AK112

iv, q2w

Intervention Type: DRUG

Oxaliplatin

iv, q2w

Intervention Type: DRUG

Irinotecan

iv, q2w

Intervention Type: DRUG

Leucovorin and 5-FU

iv, q2w

Intervention Type: DRUG

Bevacizumab

iv, q2w

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Akeso

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Sixth Hospital,Sun Yat-sen University

Guanzhou, Guangdong, China

Sun Yat-sen University Cancer Center

Guanzhou, Guangdong, China

Countries

China

Central Contacts

Xufang Yu, MD

Role: CONTACT

clincialtrails@akesobio.com

+86(0760)89873999

Facility Contacts

Yanhong DENG, MD

Role: primary

Ruihua Xu, MD

Role: primary

Other Identifiers

AK112-312

Identifier Type: -

Identifier Source: org_study_id