NCT07474727

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Multitude Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

• Colorectal Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-09-30
• Completion: 2028-02-28
• First posted: 2026-03-16
• Last updated: 2026-03-16