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

Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Study ID
NCT03491631
Phase
PHASE1
Status
Unknown

Conditions

  • Cancer, Metastatic
  • Neoplasm Malignant
  • Tumor, Solid

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Nov 20, 2018
Status verified
Nov 2022
Primary completion
Jun 30, 2023
Completion
Sep 30, 2023

Study Design

Enrollment
23 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Experimental: 2 drugs combination group
  • Experimental: 3 drugs combination group

Primary Outcome Measure

DLT [ Time Frame: Baseline through 27/28 days ]

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