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

NCT07474727 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2026-03-16

No results posted yet for this 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.

Conditions

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) or every 4 weeks (Q4W).

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

Sponsors & Collaborators

  • Multitude Therapeutics Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2027-09-30
Completion
2028-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07474727 on ClinicalTrials.gov