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IN10018 Combination Therapy in Previously-treated Locally Advanced or Metastatic Solid Tumor Patients

Locally Advanced or Metastatic Solid Tumors Clinical Trial

Official title:
A Phase Ib/II, Open-label, Multicenter Clinical Study to Evaluate the Antitumor Activities, Safety, and Tolerability of IN10018 Combination Therapy in Previously-treated Locally Advanced or Metastatic Solid Tumor Patients

Clinical Trial Summary

This is a multicenter, open-label, Phase Ib/II clinical trial to evaluate the safety, tolerability, and antitumor efficacy of IN10018 in combination with pegylated liposomal doxorubicin (PLD) or IN10018 in combination with PLD and anti-PD-1 in subjects with locally advanced or metastatic solid tumors who have failed or not tolerated to at least first-line system therapy.

Clinical Trial Description

This study is a phase Ib/II, multicenter, open-label clinical study. This study consists of 2 parts: 1) Efficacy exploration part: including phase-Ib study (dose confirmation part) and phase II study, the purpose of phase Ib-dose confirmation part is to determine the Phase II recommended dose (RP2D) of IN10018 in combination with Pegylated liposomal doxorubicin (PLD) and programmed death-1 (PD-1) monoclonal antibody. The Phase II study will explore the antitumor efficacy and safety of IN10018 in combination with PLD or IN10018 in combination with PLD and anti-PD-1 monoclonal antibody in subjects with locally advanced or metastatic solid tumors who have failed or are intolerant to at least first-line system therapy; 2) Efficacy confirmation part: The antitumor efficacy and safety of combination therapy in the corresponding solid tumors will be further confirmed. ;

Study Design

Related Conditions & MeSH terms

  • Locally Advanced or Metastatic Solid Tumors
  • Neoplasms
Clinical Trial Details
NCT number NCT05830539
Study type Interventional
Source InxMed (Shanghai) Co., Ltd.
Contact
Status Active, not recruiting
Phase Phase 1/Phase 2
Start date March 10, 2022
Completion date December 31, 2024
View Details
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