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A Phase II Study of AMT-676 Combination Therapies in Advanced Colorectal Cancer | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE2

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

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

NCT07474727•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.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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
+9 more criteria

Key Dates

Start Date

April 1, 2026

Primary Completion Date

September 30, 2027

Completion Date

February 28, 2028

Last Updated

March 16, 2026

Enrollment

180

ESTIMATED participants

Conditions

Colorectal Cancer

Interventions

AMT-676

DRUG

5-FU

DRUG

Leucovorin

DRUG

Bevacizumab

DRUG

Cetuximab

DRUG

Irinotecan

DRUG

Oxaliplatin

DRUG

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Metastatic Colorectal AdenocarcinomaStage III Colorectal Cancer AJCC v8+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 16, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors