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NOT YET RECRUITING
NCT07474727
PHASE2

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

Sponsor: 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.

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

2026-04-01

Completion Date

2028-02-28

Last Updated

2026-03-16

Healthy Volunteers

No

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