Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:
Adil Daud

Description

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.

Official Title

A Phase 1, Open-Label, Dose Escalation and Dose Expansion Trial Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Effects of Orally Administered CA-170 in Patients With Advanced Tumors and Lymphomas

Keywords

Advanced Solid Tumors or Lymphomas Mesothelioma PD-L1 VISTA PD-1 Lymphoma CA-170

Eligibility

You can join if…

Open to people ages 18 years and up

  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).

You CAN'T join if...

  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;

Locations

  • University of California San Francisco in progress, not accepting new patients
    San Francisco California 94143 United States
  • Sarah Cannon Research Institute at HealthONE in progress, not accepting new patients
    Denver Colorado 80218 United States

Lead Scientist

  • Adil Daud
    Professor, Medicine. Authored (or co-authored) 121 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Curis, Inc.
ID
NCT02812875
Phase
Phase 1
Study Type
Interventional
Last Updated