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

RECRUITINGPhase 2Sponsored by Multitude Therapeutics Inc.
Actively Recruiting
PhasePhase 2
SponsorMultitude Therapeutics Inc.
Started2026-04-29
Est. completion2027-09-30
Eligibility
Age18 Years – 80 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT07474727

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 Years – 80 YearsHealthy volunteers accepted
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

Conditions2

CancerColorectal Cancer

Interventions7

5-FUAMT-676BevacizumabCetuximabIrinotecanOxaliplatinleucovorin

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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