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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CA-170 | Experimental | Taken orally in a once or twice daily schedule. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CA-170 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The number of patients with a dose-limiting toxicity (DLT) in the first treatment cycle | Approximately 24 months | |
| Maximum tolerated dose (MTD) of CA-170 | Approximately 24 months | |
| Recommended Phase 2 Dose (RP2D) of CA-170 | Approximately 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (PK) Profile of CA-170 | Maximum Concentration (Cmax) | From Day 1 of Cycle 1(each cycle is 21 days) |
| Pharmacokinetic (PK) Profile of CA-170 | Area Under the Curve (AUC) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco | San Francisco | California | 94143 | United States | ||
| Sarah Cannon Research Institute at HealthONE |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34493823 | Derived | Zong L, Mo S, Sun Z, Lu Z, Yu S, Chen J, Xiang Y. Analysis of the immune checkpoint V-domain Ig-containing suppressor of T-cell activation (VISTA) in endometrial cancer. Mod Pathol. 2022 Feb;35(2):266-273. doi: 10.1038/s41379-021-00901-y. Epub 2021 Sep 7. | |
| 29448849 | Derived | Li K, Tian H. Development of small-molecule immune checkpoint inhibitors of PD-1/PD-L1 as a new therapeutic strategy for tumour immunotherapy. J Drug Target. 2019 Mar;27(3):244-256. doi: 10.1080/1061186X.2018.1440400. Epub 2018 Feb 20. |
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|
| 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 | 36 months |
| Denver |
| Colorado |
| 80218 |
| United States |
| Sarah Cannon Research Institute | Sarasota | Florida | 34232 | United States |
| Northwestern University | Chicago | Illinois | 60208 | United States |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| Icahn School of Medicine at Mt. Sinai | New York | New York | 10029 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Carolina BioOncology Institute | Huntersville | North Carolina | 28078 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15237 | United States |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | United States |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Yonsei University Health System - Severance Hospital | Seoul | 3722 | South Korea |
| Asan Medical Center | Seoul | 5505 | South Korea |
| Hospital Clinic i Provincial | Barcelona | 08036 | Spain |
| Catalan Institute of Oncology | Barcelona | 08907 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Cambridge University Hospitals NHS Foundation Trust | Cambridge | CB2 0QQ | United Kingdom |
| Guy's and St Thomas' NHS Foundation Trust | London | SE1 9RT | United Kingdom |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D008654 | Mesothelioma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D018301 | Neoplasms, Mesothelial |
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