NCT03491631

Phase I Study of SHR9146 + SHR-1210 +/- Apatinib in Patients With Advanced Solid Tumors

A Phase I Study to Characterize the Tolerance, Safety, Pharmacokinetics/Pharmacodynamics and Effect of PD-1 Inhibitor SHR-1210 in Combination With IDO Inhibitor SHR9146 and With/Without Apatinib in Patients With Advanced Solid Tumors (PIANO)

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tumor, Solid
• Cancer, Metastatic
• Neoplasm Malignant

Interventions

Type	Name	Description
DRUG	SHR9146+SHR-1210	SHR9146: Initial dose of 100mg BID with escalation planned to 600mg BID; SHR-1210: 200mg Q2W
DRUG	SHR9146+SHR-1210+Apatinib	SHR9146: Initial dose of 100mg BID with escalation planned to 600mg BID; SHR-1210: 200mg Q2W Apatinib:250mg QD

Timeline

• Start date: 2018-11-20
• Primary completion: 2023-06-01
• Completion: 2023-09-01
• First posted: 2018-04-09
• Last updated: 2022-11-04

Locations

1 site across 1 country: China