Clinical Trials Logo
  1. Home
  2. Tumor, Solid
  3. NCT03491631

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

Tumor, Solid Clinical Trial

Official title:
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)

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03491631
Study type Interventional
Source Jiangsu HengRui Medicine Co., Ltd.
Contact
Status Active, not recruiting
Phase Phase 1
Start date November 20, 2018
Completion date September 2023
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05094804 - A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents Phase 1/Phase 2
Recruiting NCT05637034 - 68Ga-DOTA-F2 PET/CT in Patients With Various Types of Cancer N/A
Terminated NCT04095091 - Real-time Tumor Localization and Guidance for Radiotherapy Using Ultrasound (US) and Magnetic Resonance (MR)
Recruiting NCT05378425 - A Study of NTX-1088, a Monoclonal Antibody Targeting the Poliovirus Receptor (PVR, CD155), as Monotherapy and Combined With Pembrolizumab Phase 1
Not yet recruiting NCT04723810 - TumorGlow Intraoperative Molecular Imaging (IMI) Phase 1/Phase 2
Recruiting NCT06116032 - Immune Profiling for Cancer Immunotherapy Response
Recruiting NCT06090266 - A Study of OR502, a Monoclonal Antibody Targeting LILRB2, Alone and in Combination With Anticancer Agents Phase 1/Phase 2
Recruiting NCT04416165 - Comparison of FDG and FAPI in Patients With Various Types of Cancer N/A
Recruiting NCT05620134 - Study of JK08 in Patients With Unresectable Locally Advanced or Metastatic Cancer Phase 1/Phase 2
Recruiting NCT04750772 - Positron Nuclide Labeled DOTA-FAPI PET Study in Colocrectal Cancer N/A
Recruiting NCT06022029 - A Dose Escalation and Dose Expansion Study of Intratumoral ONM-501 Alone and in Combination With Cemiplimab in Patients With Advanced Solid Tumors and Lymphomas. Phase 1
Terminated NCT01358331 - A Study of the Safety, Tolerability, and Efficacy of MK-8353 in Participants With Advanced Solid Tumors (MK-8353-001) Phase 1
Recruiting NCT06175221 - Autologous TLPO Vaccine Basket Phase 2
Recruiting NCT05661461 - Dose-escalation Study to Assess Safety and Pharmacokinetics of Nab-Sirolimus in Patients With Locally Advanced or Metastatic Solid Tumors and Moderate Liver Impairment Phase 1
Active, not recruiting NCT04196530 - BDB001-102: Open Label Dose Escalation of BDB001 in Combination w Atezolizumab Phase 1
Not yet recruiting NCT03731390 - GR1405 Injection in Patients With Advanced Solid Tumor or Lymphoma Phase 1
Recruiting NCT06193902 - LEU01101: Safety and Preliminary Efficacy of LEU011 in Solid Tumours. Phase 1/Phase 2
Active, not recruiting NCT04528836 - First-in-Human Study of the SHP2 Inhibitor BBP-398 in Patients With Advanced Solid Tumors Phase 1
Recruiting NCT05221320 - Trial of Ulixertinib in Combination With Hydroxychloroquine in Patients With Advanced Gastrointestinal (GI) Malignancies Phase 2
Not yet recruiting NCT04367948 - Positron Nuclide Labeled NOTA-FAPI PET Study in Lymphoma N/A