NCT05830539

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: InxMed (Shanghai) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Locally Advanced or Metastatic Solid Tumors

Interventions

Type	Name	Description
DRUG	IN10018+PLD	IN10018 orally once daily; PLD 40mg/m2, Q4W
DRUG	IN10018+PLD+Toripalimab	IN10018 orally once daily; PLD 40mg/m2, Q4W; Toripalimab 3 mg/kg, Q2W

Timeline

• Start date: 2022-03-10
• Primary completion: 2024-08-31
• Completion: 2024-11-22
• First posted: 2023-04-26
• Last updated: 2025-05-02

Locations

7 sites across 1 country: China