A Phase II Study of AMT-676 Combination Therapies in Advanced Colorectal Cancer
ConditionColorectal Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorMultitude Therapeutics Inc.
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- AMT-676
- 5-FU
- Leucovorin
- Bevacizumab
- Cetuximab
- Irinotecan
- Oxaliplatin
Treatment groups
180 Participants
are divided into 3 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov