Study of HC006 in Combination With a PD-1 Inhibitor in Patients With Advanced Solid Tumors

Sponsor
HC Biopharma Inc.
Study ID
NCT06963814
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • HC006 — DRUG
    Specified dose on specified days
  • KEYTRUDA ®( Pembrolizumab) — DRUG
    Specified dose on specified days

Study Details

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.

Key Dates

Start date
Jul 4, 2025
Status verified
Jul 2025
Primary completion
May 30, 2026
Completion
May 30, 2027

Study Design

Enrollment
252 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: HC006+ keytruda Dose Escalation
  • Experimental: HC006 +keytruda Dose Expansion

Primary Outcome Measure

Incidence of Dose Limiting Toxicities(DLTs) [ Time Frame: up to 24 months ]

Central Contacts

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