Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-FU | Drug | Fluorouracil | ALIAS |
| AMT-676 | Drug | — | UNRESOLVED |
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Cetuximab | Drug | Cetuximab | ALIAS |
| Irinotecan | Drug | Irinotecan | ALIAS |
| Leucovorin | Drug | Leucovorin | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- AMT-676(dose level 1)+5-FU+Leucovorin+Bevacizumab or Cetuximab(if applicable)
- interventionNames
- Drug: AMT-676
- Drug: 5-FU
- Drug: Leucovorin
- Drug: Bevacizumab
- Drug: Cetuximab
- type
- EXPERIMENTAL
- label
- AMT-676(dose level 2)+5-FU+Leucovorin+Bevacizumab or Cetuximab(if applicable)
- interventionNames
- Drug: AMT-676
- Drug: 5-FU
- Drug: Leucovorin
- Drug: Bevacizumab
- Drug: Cetuximab
- type
- EXPERIMENTAL
- label
- oxaliplatin/irinotecan+5-FU+ leucovorin +bevacizumab (or cetuximab)
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * 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 * Life expectancy ≥6 months * Patients must have adequate organ function * Male and female individuals with child bearing potential must agree to take effective contraceptive measures from the moment they sign the informed consent form until 6 months after the last administration of the study drug * WCBP(Women of Child-Bearing Potential) must have a negative serum pregnancy test within 7 days prior to first dose of the IMP * Male patients must agree not to donate sperm, and female patients must agree not to donate eggs, while on study treatment and for at least 3 months and 6 months, respectively, after the last dose of the IMP(Investigational Medicinal Product) * Availability of tumor tissue sample Exclusion Criteria: * 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 * History of thromboembolic or cerebrovascular events during last 6 mouths * During the three months prior to the first administration of the drug, there were any life-threatening bleeding events, or grade 3 or higher gastrointestinal/venous variceal bleeding events that required blood transfusion, endoscopy, or surgical treatment. Or there were other diseases that the researchers believed posed a higher risk of bleeding or thrombosis during the study period * Has a history of interstitial lung disease (ILD)/pneumonitis that required steroids, or current ILD/pneumonitis, or suspected ILD/pneumonitis , or other lung disease significantly impacting lung function at baseline. * Any other concurrent diseases or conditions that could affect the research judgment or impede the completion of the research procedures and follow-up checks * Central nervous system (CNS) metastasis * Have a history of active or acute diverticulitis, abdominal abscess, gastrointestinal obstruction, fistula, or peritoneal cancer * Any evidence indicates severe or uncontrolled systemic diseases * Acute and/or clinically significant bacterial, fungal or viral infection including hepatitis B (HBV), hepatitis C (HCV), known human immunodeficiency virus (HIV). * Administration of a live vaccine within 28 days prior to the administration of the first dose of the IMP * Patients requiring concurrent treatment of strong/moderate inhibitors or strong inducers of cytochrome P450 3A4 or 1A2 enzyme (CYP3A or CYP1A2) within 2 weeks prior to the first dose and during the study treatment * Known or suspected severe allergy/hypersensitivity (resulting in treatment discontinuation) to monoclonal antibodies * Known or suspected intolerance to the components of the IMP * Concurrent participation in another investigational therapeutic clinical trial * Pregnant or breast-feeding females * Investigator determined that the trial participants who were not suitable to participate in this study for other reasons
References
Publications (0)
Data not yet available