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

Sponsor
Multitude Therapeutics Inc.
Study ID
NCT07474727
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • AMT-676 — DRUG
    Patients will get different dose levels treatment of AMT-676. AMT-676 will be Administered as an intravenous (IV) infusion every 2 weeks (Q2W) .
  • 5-FU — DRUG
    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
  • Leucovorin — DRUG
    Leucovorin 400 mg/m\^2 IV day 1, q2w
  • Bevacizumab — DRUG
    Bevacizumab 5 mg/kg IV, day 1
  • Cetuximab — DRUG
    Cetuximab 500 mg/m\^2 IV over 2 hours, day 1, q2w
  • Irinotecan — DRUG
    Irinotecan 180 mg/m\^2 IV, day 1
  • Oxaliplatin — DRUG
    Oxaliplatin 85 mg/m\^2 IV, day 1

Study Details

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.

Key Dates

First listed
Mar 16, 2026
Start date
Apr 29, 2026
Status verified
Aug 2026
Primary completion
Sep 30, 2027
Completion
Feb 28, 2028

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: AMT-676(dose level 1)+5-FU+Leucovorin+Bevacizumab or Cetuximab(if applicable)
  • Experimental: AMT-676(dose level 2)+5-FU+Leucovorin+Bevacizumab or Cetuximab(if applicable)
  • Experimental: oxaliplatin/irinotecan+5-FU+ leucovorin +bevacizumab (or cetuximab)
  • Experimental: AMT-676+5-FU+Leucovorin+Bevacizumab or Cetuximab(if applicable)+Oxaliplatin

Primary Outcome Measure

AE & SAE [ Time Frame: 30 days after the last treatment ]

Central Contacts

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