A Phase II Study of AMT-676 Combination Therapies in Advanced Colorectal Cancer
About this study
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.
- Condition
- Colorectal Cancer
- Tested
- AMT-676, 5-FU, Leucovorin, Bevacizumab, Cetuximab, Irinotecan, Oxaliplatin
- Sponsor
- Multitude Therapeutics Inc.
Who can join
- Age
- 18 to 80 years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 13
- Minimum age: 18 years
- Maximum age: 80 years
- Study condition: Colorectal Cancer
- 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 20
- 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
Where
19 sites, 19 recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Shandong Cancer Hospital and Institute
Jinan, Shandong, China
Guangxi Medical University Cancer Hospital
Nanning, Gaungxi, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
and 13 more sites on ClinicalTrials.gov
Contact
-
Minqi Guan
15895820062 minqi.guan@multitudetherapeutics.com
Potential match only. Final eligibility is determined by the study team.