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RECRUITING
NCT07474727
PHASE2

A Phase II Study of AMT-676 Combination Therapies in Advanced Colorectal Cancer

Sponsor: Multitude Therapeutics Inc.

View on ClinicalTrials.gov

Summary

This study is an open, multi-center, phase II study, aiming to evaluate the safety, tolerability and efficacy of AMT-676 combined with 5-fluorouracil, leucovorin, bevacizumab (or cetuximab) in participants with advanced colorectal cancer, and to assess the PK(Pharmacokinetic) characteristics and immunogenicity of AMT-676.

Official title: An Phase II Study Evaluating the Safety and Efficacy of AMT-676 in Combination With 5-fluorouracil, Leucovorin, Bevacizumab (or Cetuximab) in Participants of Advanced Colorectal Cancer

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

180

Start Date

2026-04-29

Completion Date

2028-02-28

Last Updated

2026-08-27

Healthy Volunteers

No

Interventions

DRUG

AMT-676

Patients will get different dose levels treatment of AMT-676. AMT-676 will be Administered as an intravenous (IV) infusion every 2 weeks (Q2W) .

DRUG

5-FU

5-FU 400 mg/m\^2 IV bolus on day 1, followed by 1200 mg/m\^2/day x 2 days (total 2400 mg/m\^2 over 46-48 hours) IV continuous infusion, q2w

DRUG

Leucovorin

Leucovorin 400 mg/m\^2 IV day 1, q2w

DRUG

Bevacizumab

Bevacizumab 5 mg/kg IV, day 1

DRUG

Cetuximab

Cetuximab 500 mg/m\^2 IV over 2 hours, day 1, q2w

DRUG

Irinotecan

Irinotecan 180 mg/m\^2 IV, day 1

DRUG

Oxaliplatin

Oxaliplatin 85 mg/m\^2 IV, day 1

Locations (19)

Fujian Cancer Hospital

Fuzhou, Fujian, China

Guangxi Medical University Cancer Hospital

Nanning, Gaungxi, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, China

Wuhan Union Hospital of China

Wuhan, Hubei, China

Hubei Cancer Hospital

Wuhan, Hubei, China

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Liaoning Cancer Hospital & Institute

Shengyang, Liaoning, China

Shandong Cancer Hospital and Institute

Jinan, Shandong, China

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, China