Phase I Study of SHR9146 + SHR-1210 +/- Apatinib in Patients With Advanced Solid Tumors
Status:
Unknown status
Trial end date:
2020-05-01
Target enrollment:
Participant gender:
Summary
This phase I trial is designed to efficiently identify the dose-limiting toxicity (DLT) and
maximum tolerated dose (MTD) for the combination therapy regimen of the IDO1 inhibitor
SHR9146 when administered in combination with immune checkpoint PD-1 inhibitor SHR-1210 plus
VEGFR inhibitor Apatinib or not in subjects with advanced/metastatic solid tumors. All
subjects will receive the same standard SHR-1210 plus Apatinib (only three drugs
group)regimen, while SHR9146 in doses increasing from 100 mg twice daily to, potentially, 600
mg twice daily. Once the recommended regimen has been identified, subjects with the selected
tumor type will be enrolled into expansion cohorts based upon prior safety and tolerability
data.