A Study to Evaluate the Safety and Efficacy of Max-40279 and Toripalimab in Patients With Advanced Solid Tumors

• Status: Recruiting
• Trial end date: 2023-08-31
• Target enrollment: 0
• Participant gender: All

Summary

This include two parts, part 1 is a dose escalation study and part 2 is a dose expansion study.

• Phase: Phase 1
• 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 solid tumor.

3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

4. Expected survival >3 months.

5. 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.5.0) 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.