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Eligibility
for people ages 18 years and up
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:
Principal Investigator

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

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.

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. Active infection requiring systemic therapy;
  8. Receipt of vaccines against infectious diseases within 28 days;
  9. HIV positive or an AIDS-related illness;
  10. Active/chronic HBV or HCV infection;
  11. Uncontrolled CHF (NYHA Class 2-4), angina, MI, CVA, coronary/peripheral artery bypass graft surgery, TIA, or PE in prior 3 months;
  12. Cardiac dysrhythmias;
  13. Gastrointestinal disease that interferes with receipt of oral drugs;
  14. Concomitant malignancy;
  15. Pregnant or lactating female;

Locations

  • Sarah Cannon Research Institute at HealthONE accepting new patients
    Denver, Colorado, 80218, USA
  • Sarah Cannon Research Institute accepting new patients
    Sarasota, Florida, 34232, USA
  • Carolina BioOncology Institute accepting new patients
    Huntersville, North Carolina, 28078, USA
  • University of Pittsburgh Medical Center accepting new patients
    Pittsburgh, Pennsylvania, 15237, USA
  • Sarah Cannon Research Institute accepting new patients
    Nashville, Tennessee, 37203, USA

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Curis, Inc.
ID
NCT02812875
Phase
Phase 1
Lead Scientist
Adil Daud
Study Type
Interventional
Last Updated
December 2016
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