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

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 ]
4.  

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).
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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;