NCT07477743

A Phase Ib Clinical Study on the Safety and Efficacy of HC010 Combinations in Advanced Solid Tumors

Phase Ib Study to Evaluate the Tolerability, Safety, Pharmacokinetics and Preliminary Efficacy of HC010 Combinations in Patients With Advanced Solid Tumors and Determine the Recommended Dose for Subsequent Studies.

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 331 (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 gastrointestinal 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- Gastrointestinal Cancer Population. The objective of this study is to evaluate the tolerability, safety, pharmacokinetics and preliminary efficacy of HC010 in combination with chemotherapy regimens in patients with advanced gastrointestinal 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	the combination chemotherapy regimens are all commonly used in clinical practice
DRUG	Oxaliplatin	the combination chemotherapy regimens are all commonly used in clinical practice
DRUG	Capecitabine	the combination chemotherapy regimens are all commonly used in clinical practice
DRUG	HC006	HC006 once every 3 weeks (Q3W) by intravenous drip

Timeline

• Start date: 2026-03-17
• Primary completion: 2027-12-31
• Completion: 2028-03-31
• First posted: 2026-03-17
• Last updated: 2026-03-17

Locations

1 site across 1 country: China