A Study of CA-170 (Oral PD-L1, PD-L2 and VISTA Checkpoint Antagonist) in Patients With Advanced Tumors and Lymphomas

• Status: Completed
• Trial end date: 2020-05-07
• Target enrollment: 0
• Participant gender: All

Summary

CA-170 is a rationally designed and orally available, small molecule that directly targets the Programmed death-ligands 1 and 2 (PD-L1/PD-L2), and V-domain Ig suppressor of T cell activation (VISTA) immune checkpoints and results in activation of T cell proliferation and cytokine production. This is a multi-center, open-label, Phase 1 trial of orally administered CA-170 in adult patients with advanced solid tumors or lymphomas who have progressed or are non-responsive to available therapies and for which no standard therapy exists.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Curis, Inc.

Criteria

Inclusion Criteria:

1. Males and females ≥ 18 years of age;

2. Life expectancy of at least 3 months;

3. ECOG PS ≤ 1;

4. Acceptable bone marrow and organ function at screening;

5. Ability to swallow and retain oral medications;

6. Negative serum pregnancy test in women of childbearing potential;

7. Measurable disease;

8. Tumor for which standard therapy, including approved anti-PD-1 or anti-PD-L1 therapy, when applicable, does not exist or is no longer effective. For patients enrolling into backfill of dose levels at or below the MTD/RP2D, patients with tumor types known to have a high VISTA expression (such as metastatic malignant pleural mesothelioma of epithelioid histology).

Exclusion Criteria:

1. Prior treatment anti-cancer therapy or use of any investigational agent within the past 28 days or 5 half-lives, whichever is shorter;

2. Toxicity from prior chemotherapy that has not resolved to Grade ≤ 1;

3. Radiotherapy within the last 21 days;

4. Primary brain tumors or CNS metastases;

5. Major or minor surgery < 28 and <14 days from the start of treatment, respectively;

6. Active autoimmune disease or any medical condition requiring the use of systemic immunosuppressive medications;

7. Endocrinopathies, unless on stable hormone replacement therapy;

8. Active infection requiring systemic therapy;

9. Receipt of live vaccines against infectious diseases within 28 days;

10. HIV positive or an AIDS-related illness;

11. Active/chronic HBV or HCV infection;

12. Uncontrolled CHF (NYHA Class 2-4), angina, MI, CVA, coronary/peripheral artery bypass graft surgery, TIA, or PE in prior 3 months;

13. Cardiac dysrhythmias;

14. Gastrointestinal disease that interferes with receipt of oral drugs;

15. Concomitant malignancy;

16. Pregnant or lactating female;