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A Phase II Study of AMT-676 Combination Therapies in Advanced Colorectal Cancer
Sponsor: Multitude Therapeutics Inc.
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
Conditions
Interventions
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) .
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
Leucovorin
Leucovorin 400 mg/m\^2 IV day 1, q2w
Bevacizumab
Bevacizumab 5 mg/kg IV, day 1
Cetuximab
Cetuximab 500 mg/m\^2 IV over 2 hours, day 1, q2w
Irinotecan
Irinotecan 180 mg/m\^2 IV, day 1
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