A Phase 2 Study to Evaluate the Safety and Efficacy of Max-40279-01 in Patients With Advanced Colorectal Cancer

• Status: Not yet recruiting
• Trial end date: 2022-10-31
• Target enrollment: 0
• Participant gender: All

Summary

This include two parts, part 1 is a dose optimizing study and part 2 is a randomized, controlled study.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Maxinovel Pty., Ltd.

Criteria

Inclusion Criteria:

• 1. Males and/or females over age 18 2. Histologically and/or cytologically documented local advanced or metastatic colorectal adenocarcinoma.

3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 4. Expected survival >3 months. 5. previously treated with standard, approved therapies, including two lines of chemotherapy (fluoropyrimidine,oxaliplatin and irinotecan based), a biological VEGF inhibitor, and, if RAS wild-type, an EGFR inhibitor. Patients with MSI-H/MMR-deficient tumors also must have received an immune checkpoint inhibitor, if available and approved. In addition, patients with BRAF mutant tumors must also have received a BRAF inhibitor, if available and approved. 6. Signed informed consent form.

Exclusion Criteria:

• 1. Known uncontrolled or symptomatic central nervous system metastatic disease. 2. Adverse events (with exception of alopecia, peripheral sensory neuropathy grade ≤ 2 and those listed in specific exclusion criteria) from any prior anticancer therapy of grade >1 (National Cancer Institute Common terminology Criteria [NCI CTCAE] v.3.0) at the time of randomization.

3. Inadequate organ or bone marrow function. 4. Medical history of difficulty swallowing, malabsorption or other chronic gastrointestinal disease, or conditions that may hamper compliance and/or absorption of the tested product.

5. Pregnant or breast-feeding woman. 6. Known allergies, hypersensitivity, or intolerance to Max-40279-01 the excipients of these treatments The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.