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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
71
Dose escalation stage (Phase 1a) accelerated titration and standard 3+3 dose escalation in patients with advanced solid tumor or lymphoma. Dose expansion stage (Phase 1b) in patients with tumors that are shown to be responsive to anti-PD-1 or anti-PD-L1 checkpoint inhibitors and/or in tumor types known to express PD-L1 or VISTA, including but not limited to: mesothelioma, melanoma, non-small cell lung cancer, renal cell carcinoma, Hodgkin lymphoma, triple negative breast cancer, head and neck cancer, colorectal cancer, gastric cancer, bladder cancer, and ovarian cancer.
University of California San Francisco
San Francisco, California, United States
The number of patients with a dose-limiting toxicity (DLT) in the first treatment cycle
Time frame: Approximately 24 months
Maximum tolerated dose (MTD) of CA-170
Time frame: Approximately 24 months
Recommended Phase 2 Dose (RP2D) of CA-170
Time frame: Approximately 24 months
Pharmacokinetic (PK) Profile of CA-170
Maximum Concentration (Cmax)
Time frame: From Day 1 of Cycle 1(each cycle is 21 days)
Pharmacokinetic (PK) Profile of CA-170
Area Under the Curve (AUC)
Time frame: From Day 1 of Cycle 1(each cycle is 21 days)
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
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