Study of CPI-0209 for Patients with Advanced Solid Tumors and Lymphomas

Program Overview

This study is the first time CPI-0209 is being tested in humans. It is an open-label study, meaning both the researchers and participants know what treatment is being given. The study will be conducted in two phases. Phase 1 will focus on finding the safest dose of CPI-0209 for patients with advanced tumors. Phase 2 will evaluate how well CPI-0209 works in specific types of cancer, including different solid tumors and lymphomas, and will further assess its safety and effectiveness.

Description

The study is divided into two phases:

Phase 1:

• This phase will determine the safest dose of CPI-0209 for patients with advanced solid tumors and lymphomas. Patients will receive increasing doses of the drug to find the maximum dose that can be tolerated without severe side effects.

Phase 2:

• This phase will test CPI-0209 in specific groups of patients with different types of cancer. The goal is to see how well the drug works in shrinking tumors and to continue monitoring its safety.
• Patients will be divided into six groups based on their type of cancer. Each group will have a specific number of participants.
• Some groups will test different doses of CPI-0209 to find the most effective dose.

Inclusion Criteria:

• Phase 1:

  • Adults with advanced solid tumors or lymphomas that have not responded to standard treatments or for which no standard treatment exists.

• Phase 2:

  • Life expectancy of at least 12 weeks.

  • Good overall health with a performance status of 0 or 1.

  • Adequate bone marrow, kidney, and liver function.

  • Cohort M1:

    • Advanced urothelial carcinoma or other solid tumors with a specific genetic mutation (ARID1A).
    • Disease progression after standard treatments.

  • Cohort M2:

    • Advanced ovarian clear cell carcinoma with ARID1A mutation.
    • Received at least one line of platinum-based chemotherapy and bevacizumab unless not suitable.

  • Cohort M3:

    • Recurrent or metastatic endometrial carcinoma with ARID1A mutation.
    • Received platinum-based treatment and other specific therapies unless not suitable.

  • Cohort M4:

    • Specific types of lymphoma (PTCL or DLBCL) that have not responded to previous treatments.
    • Not eligible for certain transplants due to disease status or other factors.

  • Cohort M5:

    • Relapsed or refractory mesothelioma with specific genetic changes.

  • Cohort M6:

    • Metastatic disease with specific conditions related to prostate cancer.

Exclusion Criteria:

• Previous organ or bone marrow transplants.
• Untreated brain metastases or significant heart disease.
• Recent major surgery or uncontrolled infections.
• History of certain lung diseases or other cancers.
• Active infections like HIV, hepatitis B, or C.
• Recent use of certain cancer treatments or medications that affect the study drug.
• Pregnant or breastfeeding women, or those planning to conceive during the study.
• Specific conditions for Cohort M6 related to prostate cancer treatment.

Eligibility Criteria