drugset / Trial / NCT03161431

Summary

Cancers attract myeloid-derived suppressor cells (MDSCs) that prevent our own immune responses from destroying the cancer. This study will be the first study to begin to determine if the newly discovered drug SX-682 can block cancers from attracting MDSCs. This first study will enroll participants with melanoma, as melanoma cancer has been shown to be able to attract MDSCs. The study will begin to determine if SX-682 is a safe and effective treatment of melanoma. It is thought that SX-682 will block MDSCs from going to the cancer, and thus will allow a patient's own immune system to attack the cancer. The first participants enrolled in the study will receive for 21 days SX-682 as monotherapy. After 21 days participants will receive pembrolizumab therapy (an approved immunotherapy for melanoma) in combination with SX-682 for up to approximately 2 years. Once the safe dose level of SX-682 in combination with pembrolizumab is determined, the remaining participants will be enrolled at the highest safe dose level of SX-682, in combination with pembrolizumab. These participants will receive the combination therapy and be evaluated in the study for approximately 2 years.

Timeline

Start
2019-06-12
Primary completion
2026-08
Completion
2027-06

Drugs

EvaluationDrugModalityDoseRoute
Subject SX-682 Small molecule 25 mg Oral
Subject SX-682 Small molecule 50 mg Oral
Subject SX-682 Small molecule 100 mg Oral
Subject SX-682 Small molecule 200 mg Oral
Subject SX-682 Small molecule 400 mg Oral
Background Pembrolizumab Monoclonal antibody Intravenous

Indications