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Study of HC006 in Combination With a PD-1 Inhibitor in Patients With Advanced Solid Tumors
Sponsor: HC Biopharma Inc.
Summary
This is an open-label, multicenter Phase 1b clinical study to evaluate the safety, tolerability, pharmacokinetics, immunogenicity and preliminary efficacy of HC006 in combination with a PD-1 inhibitor in patients with advanced solid tumors. The trial is divided into two stages: dose-escalation and dose expansion. First, the dose-escalation study is completed to determine the recommended dose for subsequent extension studies, and then the dose expansion study is conducted in the proposed tumors with potential treatment benefits.
Official title: A Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy Study of HC006 in Combination With a PD-1 Inhibitor in Patients With Advanced Solid Tumors:A Multicenter, Open-Label, Dose-Escalation and Multiple Cohort Dose Expansion Phase 1b Clinical Trial
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
252
Start Date
2025-07-04
Completion Date
2027-05-30
Last Updated
2025-07-17
Healthy Volunteers
No
Conditions
Interventions
HC006
Specified dose on specified days
KEYTRUDA ®( Pembrolizumab)
Specified dose on specified days
Locations (1)
Shanghai East Hospital
Shanghai, Shanghai Municipality, China