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

NCT05382442 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 254

Last updated 2025-10-14

No results posted yet for this 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.

Conditions

Interventions

DRUG

AK112

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

DRUG

AK117

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

DRUG

Oxaliplatin

Oxaliplatin via IV infusion

DRUG

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

DRUG

Irinotecan

Irinotecan via IV infusion

DRUG

Leucovorin

Leucovorin via IV infusion

DRUG

5-fluorouracil

5-fluorouracil via IV infusion

Sponsors & Collaborators

  • Summit Therapeutics

    collaborator INDUSTRY

  • Akeso

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-27
Primary Completion
2026-05-15
Completion
2028-08-12
FDA Drug
Yes

Countries

  • United States
  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05382442 on ClinicalTrials.gov