BC3402 w/ Tremelimumab + Durvalumab (STRIDE) in Hepatocellular Carcinoma

Conditions

• Hepato Cellular Carcinoma (HCC)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• BC3402 — DRUG
  BC3402, intravenous, 20 mg/kg, D1 and D15 of every 28 day cycle, continuous. BC3402 to be administered after completion of the infusion of durvalumab and/or tremelimumab on the days when BC3402 is to be administered with durvalumab and/or tremelimumab
• Durvalumab — DRUG
  Durvalumab, intravenous, 1500 mg, every 4 weeks, continuous
• Tremelimumab — DRUG
  Tremelimumab, intravenous, 300 mg, 1 dose on Cycle 1 Day 1

Study Details

The purpose of this study is to test the safety and efficacy of an investigational (experimental) product called BC3402. This product is considered experimental because it is not approved by the U.S. Food and Drug Administration (FDA).

Key Dates

Start date

Nov 30, 2025

Status verified

Feb 2026

Primary completion

Jan 1, 2027

Completion

Jan 1, 2028

Study Design

Enrollment

0 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: BC3402 to tremelimumab plus durvalumab
  The study consists of two parts: a safety lead-in study part (Phase Ib) to confirm the tolerable dose (RP2D) of BC3402 in combination with T+D followed by an efficacy study part (Phase II) to evaluate preliminary efficacy of the study regimen in a single arm, two stage Minimax design. Note that participants who are treated at the RP2D in the Phase Ib study part will automatically be part of the Phase II study part.

Primary Outcome Measure

Overall response rate(ORR) per RECIST v1.1 [ Time Frame: From registration up to 2 years post end of treatment(EOT) or study closure ]

Locations (1)

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