From the blog

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

Published: February 25, 2019

Primary Outcome Measures

  1. The number of patients with a dose-limiting toxicity (DLT) in the first treatment cycle [ Time Frame: Approximately 24 months ]
  2. Maximum tolerated dose (MTD) of CA-170 [ Time Frame: Approximately 24 months ]
  3. Recommended Phase 2 Dose (RP2D) of CA-170 [ Time Frame: Approximately 24 months ]

Secondary Outcome Measures

  1. Pharmacokinetic (PK) Profile of CA-170 [ Time Frame: From Day 1 of Cycle 1(each cycle is 21 days) ]Maximum Concentration (Cmax)
  2. Pharmacokinetic (PK) Profile of CA-170 [ Time Frame: From Day 1 of Cycle 1(each cycle is 21 days) ]Area Under the Curve (AUC)
  3. Preliminary Anti-tumor Activity of CA-170 based on RECIST and Immune Related Response Criterion (irRC) for Solid Tumors or Cheson for Lymphoma [ Time Frame: 36 months ]

Inclusion Criteria

  • 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).

Exclusion Criteria

  • 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;
Contact Us
Have you received a diagnosis? *