NCT05982522

IN10018 Combination Therapy in Previously-treated Solid Tumors

A Multicenter, Open-Label, Randomized, Phase Ib/II Clinical Trial to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of IN10018 Combined With Taxane and Anti-PD-1/L1 Monoclonal Antibody in Previously-treated Solid Tumors

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: InxMed (Shanghai) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a phase Ib/II, randomized, open-label, multicenter clinical trial to evaluate the antitumor activities, safety, tolerability and pharmacokinetics (PK) of IN10018 in combination with taxane and anti-PD-1/L1 monoclonal antibody in patients with locally advanced or metastatic solid tumors who have failed in or been intolerant to at least one line of standard therapy. This study will be firstly carried out in previously-treated non-small cell lung cancer (NSCLC) population,

Detailed description

This study consists of 2 parts: 1) Phase Ib-Dose Confirmation part: To assess the safety and recommended phase II dose (RP2D) of IN10018 in combination with taxane (nab-paclitaxel is proposed) and anti-PD-1/L1 monoclonal antibody (Tislelizumab is proposed) in previously-treated solid tumors. 2) Phase II-Dose Expansion part: To assess the antitumor efficacy and safety of IN10018+nab-paclitaxel+Tislelizumab as compared to nab-paclitaxel+Tislelizumab in previously-treated solid tumors. This study will be firstly carried out in previously-treated NSCLC population, and after getting enough efficacy and safety data of IN10018+nab-paclitaxel+Tislelizumab in NSCLC population and also taken into consideration of disease background of other specific solid tumors, sponsor will decide if to expand the treatment regimen into other solid tumors.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	IN10018	orally taken once daily
DRUG	Nab-paclitaxel	125 mg/m2 D1, 8 Q3W, Intravenously
DRUG	Tislelizumab	200mg Q3W, Intravenously

Timeline

• Start date: 2025-08-13
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2023-08-08
• Last updated: 2026-03-27