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A Phase Ib/II Clinical Study on AK112 Combined or Not Combined With AK119 in pMMR/MSS Colorectal Cancer

NCT05846867 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2026-03-04

No results posted yet for this study

Summary

This is an open label, multicenter Phase Ib/II clinical study on the efficacy and safety of AK119 and AK112 in combination with or without chemotherapy, and AK112 monotherapy in pMMR/MSS CRC

Conditions

Interventions

DRUG

AK119

AK119 IV every 2 weeks.intravenous infusion

DRUG

AK112

AK112 IV every 2 weeks.intravenous infusion

DRUG

Oxaliplatin

Oxaliplatin: 85mg/m2, intravenous infusion

DRUG

Irinotecan

Irinotecan 180mg/m2, intravenous infusion

DRUG

Calcium folinate

Calcium folinate: 400mg/m2, intravenous infusion

DRUG

Fluorouracil

Fluorouracil 400mg/m2, intravenous injection

Sponsors & Collaborators

Principal Investigators

  • Yanqiao Zhang, PhD · Cancer Hospital Affiliated to Harbin Medical University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-08
Primary Completion
2026-05-08
Completion
2026-08-11

Countries

  • 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 NCT05846867 on ClinicalTrials.gov