NCT07381829

A Phase Ib Clinical Study on the Safety and Efficacy of HC010 Combined With Chemotherapy in Lung Cancer

Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy Study of the Combination Therapy With HC010 for Injection in Patients With Advanced Solid Tumors:A Multicenter, Open-Label, Dose Range-Finding and Multiple Cohort Dose Expansion Phase Ib Clinical Trial-Lung Cancer Population

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 328 (estimated)
• Sponsor: HC Biopharma Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Phase Ib study to evaluate the tolerability, safety, pharmacokinetics and preliminary efficacy of HC010 in combination with chemotherapy regimens in patients with advanced lung cancer and determine the recommended dose for subsequent studies.

Detailed description

This clinical trial is a multicenter, open-label, dose range-finding and multiple cohort dose expansion Phase Ib Clinical Trial-Lung Cancer Population.The goal of this study is to evaluate the tolerability, safety, pharmacokinetics and preliminary efficacy of HC010 in combination with chemotherapy regimens in patients with advanced lung cancer and determine the recommended dose for subsequent studies.

Conditions

• Advanced Solid Tumor Cancer

Interventions

Type	Name	Description
DRUG	HC010	HC010 once every 3 weeks (Q3W) by intravenous drip
DRUG	Paclitaxel (Chemotherapy)	the combination chemotherapy regimens are all commonly used in clinical practice
DRUG	Pemetrexed	the combination chemotherapy regimens are all commonly used in clinical practice
DRUG	Etoposide	the combination chemotherapy regimens are all commonly used in clinical practice
DRUG	Carboplatin/Cisplatin	the combination chemotherapy regimens are all commonly used in clinical practice
DRUG	Docetaxel	the combination chemotherapy regimens are all commonly used in clinical practice

Timeline

• Start date: 2025-10-27
• Primary completion: 2026-12-30
• Completion: 2026-12-30
• First posted: 2026-02-02
• Last updated: 2026-02-02

Locations

1 site across 1 country: China