Study of HC006 in Combination With a PD-1 Inhibitor in Patients With Advanced Solid Tumors
NCT06963814 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 252
Last updated 2025-07-17
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.
Conditions
Interventions
- DRUG
-
HC006
Specified dose on specified days
- DRUG
-
KEYTRUDA ®( Pembrolizumab)
Specified dose on specified days
Sponsors & Collaborators
-
HC Biopharma Inc.
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-07-04
- Primary Completion
- 2026-05-30
- Completion
- 2027-05-30
Countries
- China
Study Locations
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