A clinical trial to investigate EO4010, a novel cancer vaccine therapy, with an immune checkpoint blocker, in patients with previously treated metastatic colorectal carcinoma.
- Conditions
- Patients with unresectable, previously treated locally advanced ormetastatic colorectal carcinoma.MedDRA version: 27.0Level: LLTClassification code: 10052362Term: Metastatic colorectal cancer Class: 10029104Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-509509-62-00
- Lead Sponsor
- Enterome
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 42
HLA-A2 positive patients with advanced non-resectable colorectal adenocarcinoma which is mismatch repair proficient and microsatellite stable, who have been previously treated with, or are not considered candidates therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents, Progression during or within 3 months following the latest administration of standard therapies (outlined above), at an age = 18 years, ECOG performance status 0 to 1.
patients treated with dexamethasone > 2 mg/day or equivalent (i.e., 13 mg/day of prednisone) within 14 days before first administration of EO4010, who have received any prior treatment with compounds targeting PD1, PD-L1, CTLA-4, or similar compounds, trifluridine/tipiracil (TAS-102) or regorafenib, treated with radiotherapy within 12 weeks, and cytotoxic chemotherapy therapy within 28 days (or 5 half-lives of the compound(s) administered if longer) before study treatment start, With persistent Grade = 2 toxicities (according to NCI-CTCAE v5.0). except alopecia, neuropathy, and other persisting toxicities not constituting a safety risk based on Investigator’s judgment, With uncontrolled central nervous system (CNS) metastasis, with the significant abnormal laboratory values hematology, liver and renal function, with clinically significant active infection, cardiac disease, significant medical or psychiatric disease/condition that, in the opinion of the Investigator, would interfere with the interpretation of patient safety or study results or that would prohibit the understanding or rendering of informed consent, Patients with a history of solid organ transplantation or allogeneic hematopoietic stem cell transplantation, history or presence of human immunodeficiency virus (HIV) and/or active hepatitis B virus (HBV)/hepatitis C virus (HCV).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method