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Clinical Trials in China / NCT07474727
Recruiting Phase 2

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

NCT07474727 · tracked via the Priya Life Science China tracker
Sponsor
Multitude Therapeutics Inc.
Phase
Phase 2
Started
2026-04-29
Last updated
2026-08-27

Condition(s) studied

Colorectal Cancer

Investigational drug(s) / intervention(s)

AMT-6765-FULeucovorinBevacizumabCetuximabIrinotecanOxaliplatin

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * Patients must be willing and able to sign the ICF, and to adhere to the study visit schedule and other protocol requirements * Patients with pathologically confirmed, unresectable advanced colorectal adenocarcinoma * Patients must have at least one measurable lesion as per RECIST version 1.1 * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 * Life expectancy ≥6 months * Patients must have adequate organ function * Male and female individuals with child bearing potential must agree to take effective contraceptive measures from the moment they sign the informed consent form until 6 months after the last administration of the study drug * WCBP(Women of Child-Bearing Potential) must have a negative serum pregnancy test within 7 days prior to first dose of the IMP * Male patients must agree not to donate sperm, and female patients must agree not to donate eggs, while on study treatment and for at least 3 months and 6 months, respectively, after the last dose of the IMP(Investigational Medicinal Product) * Availability of tumor tissue sample Exclusion Criteria: * Prior treatment with any same target * Systemic anti-neoplastic therapy within five half-lives or 21 days, whichever is shorter, prior to first dose of the IMP * Persistent toxicities from previous systemic anti-neoplastic treatments of Grade \>1 * Major surgery within 28 days prior to first dose of the IMP, or no recovery from side effects of such intervention, or a surgery is planned to be conducted within the expected participation period of the trial or within 4 weeks after the last administration of the drug * History of thromboembolic or cerebrovascular events during last 6 mouths * During the three months prior to the first administration of the drug, there were any life-threatening bleeding events, or grade 3 or higher gastrointestinal/venous variceal bleeding events that required blood transfusion, endoscopy, or surgical treatment. Or there were other diseases that the researchers believed posed a higher risk of bleeding or thrombosis during the study period * Has a history of interstitial lung disease (ILD)/pneumonitis that required steroids, or current ILD/pneumonitis, or suspected ILD/pneumonitis , or other lung disease significantly impacting lung function at baseline. * Any other concurrent diseases or conditions that could affect the research judgment or impede the completion of the research procedures and follow-up checks * Central nervous system (CNS) metastasis * Have a history of active or acute diverticulitis, abdominal abscess, gastrointestinal obstruction, fistula, or peritoneal cancer * Any evidence indicates severe or uncontrolled systemic diseases * Acute and/or clinically significant bacterial, fungal or viral infection including hepatitis B (HBV), hepatitis C (HCV), known human immunodeficiency virus (HIV). * Administration of a live vaccine within 28 days prior to the administration of the first dose of the IMP * Patients requiring concurrent treatment of strong/moderate inhibitors or strong inducers of cytochrome P450 3A4 or 1A2 enzyme (CYP3A or CYP1A2) within 2 weeks prior to the first dose and during the study treatment * Known or suspected severe allergy/hypersensitivity (resulting in treatment discontinuation) to monoclonal antibodies * Known or suspected intolerance to the components of the IMP * Concurrent participation in another investigational therapeutic clinical trial * Pregnant or breast-feeding females * Investigator determined that the trial participants who were not suitable to participate in this study for other reasons

Primary outcome measure(s)

Trial sites (19)

FacilityCityRegionStatus
Fujian Cancer Hospital Fuzhou Fujian Not Yet Recruiting
Guangxi Medical University Cancer Hospital Nanning Gaungxi Recruiting
Sun Yat-sen University Cancer Center Guangzhou Guangdong Recruiting
Zhujiang Hospital of Southern Medical University Guangzhou Guangdong Recruiting
Harbin Medical University Cancer Hospital Harbin Heilongjiang Not Yet Recruiting
The First Affiliated Hospital of Henan University of Science and Technology Luoyang Henan Not Yet Recruiting
Wuhan Union Hospital of China Wuhan Hubei Not Yet Recruiting
Hubei Cancer Hospital Wuhan Hubei Not Yet Recruiting
The Second Xiangya Hospital of Central South University Changsha Hunan Not Yet Recruiting
Liaoning Cancer Hospital & Institute Shengyang Liaoning Not Yet Recruiting
Shandong Cancer Hospital and Institute Jinan Shandong Recruiting
The Affiliated Hospital of Qingdao University Qingdao Shandong Not Yet Recruiting
Fudan University Shanghai Cancer Center Shanghai Shanghai Municipality Recruiting
Shanghai Tenth People's Hospital Shanghai Shanghai Municipality Recruiting
West China Hospital of Sichuan University Chengdu Sichuan Not Yet Recruiting
Sichuan Provincial People's Hospital Chengdu Sichuan Not Yet Recruiting
Tianjin Medical University Cancer Institute and Hospital Tianjin Tianjin Municipality Recruiting
The Second Affiliated Hospital, Zhejiang University School of Medicine Hangzhou Zhejiang Recruiting
Sir Run Run Shaw Hospital Hangzhou Zhejiang Not Yet Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07474727 on ClinicalTrials.gov ↗ ← All trials in China