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Clinical Trials in China / NCT05382442
Active, not recruiting Phase 2

A Study of AK112 With or Without AK117 in Metastatic Colorectal Cancer

NCT05382442 · tracked via the Priya Life Science China tracker
Sponsor
Akeso
Phase
Phase 2
Started
2022-06-27
Last updated
2025-10-14

Condition(s) studied

Metastatic Colorectal Cancer

Investigational drug(s) / intervention(s)

AK112 →AK117 →Oxaliplatin →Capecitabine →Irinotecan →Leucovorin →5-fluorouracil →

AK112: AK112 via intravenous (IV) infusion until disease progression or unacceptable toxicity

AK117: AK117 via intravenous (IV) infusion until disease progression or unacceptable toxicity

Oxaliplatin: Oxaliplatin via IV infusion

Capecitabine: Capecitabine via oral,The total daily dose was 2000mg/sqm, Each cycle was administered for 2 consecutive weeks, followed by a week of rest, with a treatment cycle every 21 days

Irinotecan: Irinotecan via IV infusion

Leucovorin: Leucovorin via IV infusion

5-fluorouracil: 5-fluorouracil via IV infusion

Study summary

This trial is a Phase II study. The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of AK112 with or without AK117 in participants with metastatic colorectal cancer who are not suitable for surgery.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * Histologically proven diagnosis of colorectal adenocarcinoma * Part1: Subjects who have not previously received any systemic antitumor therapy and who have previously received neoadjuvant or adjuvant therapy, the first detection of recurrence or metastasis should be ≥12 months after the last administration of neoadjuvant or adjuvant therapy * Part2: Subjects who have previously received systemic therapy including fluorouracil, oxaliplatin, irinotecan, bevacizumab or anti-EGFR antibodies or could not tolerate or have contraindications to standard treatment * Eastern Cooperative Oncology Group performance status of 0 or 1 * Measurable disease as defined by RECIST v1.1 * Adequate hematologic and organ function Exclusion Criteria: * Known MSI-H(Microsatellite-Instability-High) or dMMR(Mismatch Repair-Deficient) * Prior treatment with immunotherapy, including immune checkpoint inhibitors , immune checkpoint agonists, immune cell therapy and any treatment targeting tumor immune pathway * History of autoimmune disease * Prior allogeneic stem cell or solid organ transplantation * Positive test for human immunodeficiency virus,Active hepatitis B or hepatitis C * Receipt of a live, attenuated vaccine within 30 days prior to randomization, during treatment * Pregnancy or lactation * Dysphagia

Primary outcome measure(s)

  • Objective response rates (ORR) — Up to approximately 2 years
    ORR is the proportion of subjects with complete response(CR) or partial response(PR) , based on RECIST v1.1
  • Number of participants with adverse events (AEs) — Up to approximately 2 years
    An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.

Trial sites (4)

FacilityCityRegionStatus
Summit Therapeutics Research Site Los Angeles California
Summit Therapeutics Research Site Murrieta California
Summit Therapeutics Research Site Fairfax Virginia
The Sixth Hospital,Sun Yat-sen University Guanzhou Guangdong

More Akeso trials in China

A Phase Ib/II Study of AK112 in Combination With AK117 in Advanced Malignant Tumors Active, not recruiting
A Study of AK112 as Consolidation Treatment for Patients With Limited Stage Small-cell Lung Cancer Who Have Not Progressed Following Concurrent Chemoradiation Therapy Recruiting
A Clinical Study of AK139 in Healthy Subjects Starting soon
A Study to Evaluate the Efficacy and Safety of AK139 in Participants With Seasonal Allergic Rhinitis Starting soon
A Study of AK131 in Patients With Advanced Solid Tumors Recruiting

Other trials for the same condition

A Study of Nivolumab, Nivolumab Plus Ipilimumab, or Investigator's Choice Chemotherapy for the Treatment of Participants With Deficient Mismatch Repair (dMMR)/Microsatellite Instability High (MSI-H) Metastatic Colorectal Cancer (mCRC) Active, not recruiting
Becotatug Vedotin Plus Pucotenlimab for Metastatic Colorectal Cancer Recruiting
A Study of HX008 Compared to Chemotherapy in the First-Line Treatment of Subjects With MSI-H/dMMR Metastatic Colorectal Cancer Active, not recruiting
Phase 3 Study of MRTX849 With Cetuximab vs Chemotherapy in Patients With Advanced Colorectal Cancer With KRAS G12C Mutation (KRYSTAL-10) Active, not recruiting
MRE for Assessment of Histopathological Growth Patterns in Colorectal Liver Metastases Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05382442 on ClinicalTrials.gov ↗ ← All trials in China