BC3402 in Combination With Durvalumab in Patients With Advanced Hepatocellular Carcinoma

Sponsor
Biocity Biopharmaceutics Co., Ltd.
Study ID
NCT06111326
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • BC3402 injection — DRUG
    Intravenous infusion, once every 2 weeks, 4 weeks/cycle.
  • Durvalumab injection — DRUG
    Intravenous infusion, once every 4 weeks, 4 weeks/cycle.

Study Details

Phase Ib: Dose exploration: To assess the safety, tolerability, and determine the recommended Phase 2 dose (RP2D) of BC3402 in combination with durvalumab in subjects with advanced hepatocellular carcinoma (HCC) Phase II: Dose Expansion: To assess the antitumor activity of BC3402 in combination with durvalumab in subjects with advanced HCC.

Key Dates

Start date
Oct 31, 2023
Status verified
Oct 2023
Primary completion
Aug 31, 2024
Completion
May 31, 2026

Study Design

Enrollment
83 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: BC3402+Durvalumab
    Subjects will receive BC3402 and Durvalumab in a treatment cycle.

Primary Outcome Measure

Phase Ib: Dose Exploration Part-The incidence of dose limiting toxicity (DLT) events [ Time Frame: 28 Days ]

Central Contacts

Related Studies