A Study of CA-170 (Oral PD-L1, PD-L2 and VISTA Checkpoint Antagonist) in Patients With Advanced Tumors and Lymphomas
Completed · Phase 1
Conditions studied: Advanced Solid Tumors or Lymphomas
In brief
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.
Key facts
- Study ID
- NCT02812875
- Run by
- Curis, Inc.
- People needed
- 71
- Starts
- 2016-05-01
- Expected to finish
- 2020-05-07
- Last updated by the study team
- 2020-06-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Males and females ≥ 18 years of age;
- Life expectancy of at least 3 months;
- ECOG PS ≤ 1;
- Acceptable bone marrow and organ function at screening;
- Ability to swallow and retain oral medications;
- Negative serum pregnancy test in women of childbearing potential;
- Measurable disease;
- 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 may not qualify if…
- Prior treatment anti-cancer therapy or use of any investigational agent within the past 28 days or 5 half-lives, whichever is shorter;
- Toxicity from prior chemotherapy that has not resolved to Grade ≤ 1;
- Radiotherapy within the last 21 days;
- Primary brain tumors or CNS metastases;
- Major or minor surgery < 28 and <14 days from the start of treatment, respectively;
- Active autoimmune disease or any medical condition requiring the use of systemic immunosuppressive medications;
- Endocrinopathies, unless on stable hormone replacement therapy;
- Active infection requiring systemic therapy;
- Receipt of live vaccines against infectious diseases within 28 days;
- HIV positive or an AIDS-related illness;
- Active/chronic HBV or HCV infection;
- Uncontrolled CHF (NYHA Class 2-4), angina, MI, CVA, coronary/peripheral artery bypass graft surgery, TIA, or PE in prior 3 months;
- Cardiac dysrhythmias;
- Gastrointestinal disease that interferes with receipt of oral drugs;
- Concomitant malignancy;
- Pregnant or lactating female;
Where it is running
- University of California San Francisco — San Francisco, California, United States
- Sarah Cannon Research Institute at HealthONE — Denver, Colorado, United States
- Sarah Cannon Research Institute — Sarasota, Florida, United States
- Northwestern University — Chicago, Illinois, United States
- Karmanos Cancer Institute — Detroit, Michigan, United States
- Icahn School of Medicine at Mt. Sinai — New York, New York, United States
- Memorial Sloan Kettering Cancer Center — New York, New York, United States
- Carolina BioOncology Institute — Huntersville, North Carolina, United States
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
- Sarah Cannon Research Institute — Nashville, Tennessee, United States
- University of Texas MD Anderson Cancer Center — Houston, Texas, United States
- Seoul National University Hospital — Seoul, South Korea
- Samsung Medical Center — Seoul, South Korea
- Yonsei University Health System - Severance Hospital — Seoul, South Korea
- Asan Medical Center — Seoul, South Korea
- Hospital Clinic i Provincial — Barcelona, Spain
- Catalan Institute of Oncology — Barcelona, Spain
- Hospital Universitario 12 de Octubre — Madrid, Spain
- Cambridge University Hospitals NHS Foundation Trust — Cambridge, United Kingdom
- Guy's and St Thomas' NHS Foundation Trust — London, United Kingdom
Full record on ClinicalTrials.gov
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