NCT06963502

A Phase Ib Study of HS-10370 in Addition to Other Anti-cancer Therapies in Patients With Advanced Solid Tumors

A Phase Ib Study Evaluating the Safety, Tolerability , Pharmacokinetics，Activity and Immunogenicity of HS-10370 in Addition to Other Anti-cancer Therapies in Patients With Advanced Solid Tumors

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 762 (estimated)
• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase Ib study that will evaluate the Safety, Tolerability , Pharmacokinetics, Activity and Immunogenicity of HS-10370 in Combination With Other Anti-cancer Therapies in Chinese patients with KRAS G12C mutation advanced or metastatic solid tumors, especially in and Colorectal cancer(CRC) and non-Small cell lung cancer (NSCLC).

Conditions

• Advanced Solid Tumors
• Colorectal Cancer
• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	HS-10370	Participants will receive HS-10370 dose 1 administered orally
DRUG	HS-20117	Participants will receive HS-20117 given as dose 3 intravenous infusion(IV) once every 14-day cycle.
DRUG	Adebrelimab	Participants will receive Adebrelimab intravenous infusion(IV) once every 21-day cycle
DRUG	Capecitabine	Participants will receive Capecitabine administered orally
DRUG	Oxaliplatin	Participants will receive Oxaliplatin intravenous infusion(IV) once every 21-day cycle.
DRUG	Folinic Acid, Fluorouracil and Oxaliplatin/Irinotecan	Participants will receive Folinic Acid, Fluorouracil and Oxaliplatin/Irinotecan intravenous infusion(IV) once every 14-day cycle.
DRUG	HS-20093	Participants will receive HS-20093 intravenous infusion(IV) once every 21-day cycle
DRUG	platinum (cisplatin or carboplatin)	Participants will receive platinum (cisplatin or carboplatin) administered IV in 21-day cycles.

Timeline

• Start date: 2025-05-30
• Primary completion: 2028-12-31
• Completion: 2030-04-30
• First posted: 2025-05-09
• Last updated: 2025-05-09

Locations

2 sites across 1 country: China