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A Study of Ametumumab in Combination With Anti-PD-1 Monoclonal Antibody and FOLFIRI in Patients With RAS Wild-type Advanced Colorectal Cancer

NCT05684211 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2023-02-01

No results posted yet for this study

Summary

This is a multicenter, open-label, parallel-group, randomised, A phase IIb clinical trial of efficacy and safety of Ametumumab in combination with anti-PD-1 monoclonal antibody and FOLFIRI versus Ametumumab or Cetuximab in combination with FOLFIRI in patients with RAS wild-type advanced colorectal cancer.

Conditions

Interventions

DRUG

Ametumumab

A recombinant fully human anti-EGFR monoclonal antibody

DRUG

Anti-PD-1 monoclonal antibody

Toripalimab 3 mg/kg，Intravenous titration，Q2W

DRUG

Cetuximab

Cetuximab 500 mg/m2 ，Intravenous titration，Q2W

DRUG

FOLFIRI

Rinotecan hydrochloride，180mg/m2，intravenous titration，Q2W； 5 -Fluorouracil，400 mg/ m2, intravenous push, then 1200 mg/ m2 /day x 2 days, intravenous titration,Q2W; Calcium folinate,400mg/m2,intravenous titration，Q2W

Sponsors & Collaborators

  • Shanghai Celfuture Biotech Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2023-01-31
Primary Completion
2023-01-31
Completion
2023-01-31

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

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 NCT05684211 on ClinicalTrials.gov