NCT06608940

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

A Phase Ib/II Study of BC3402, a Novel Anti-TIM3 Agent, in Combination With Tremelimumab Plus Durvalumab (STRIDE) in Advanced, Unresectable Hepatocellular Carcinoma

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

Brief Background/Rationale Hepatocellular carcinoma (HCC) is the most common liver cancer and the fastest rising cause of cancer-related deaths in the U.S. Immune checkpoint inhibitors (ICIs) proved to be highly efficacious in HCC and the dual ICIs combination, tremelimumab plus durvalumab, is a standard front-line treatment for advanced and metastatic HCC. However, the response rate of the dual ICIs regimen is about 20% and participants invariably progress. There is a need for more efficacious treatment. T cell immunoglobulin mucin-3 (TIM3) is highly expressed on multiple immune cells and plays a complex role in regulating immune responses and inducing immune tolerance. BC3402 is a TIM3 targeting inhibitory humanized IgG4 subtype monoclonal antibody which displays synergistic anti-tumor effects when combined with agents targeting PD1 and CTLA4 in preclinical tumor models as well as in the first in human (FIH) trial. Investigators hypothesize that the co-targeting of TIM3 will significantly increase the anti-tumor efficacy of dual targeting of PD1/PDL1 and CTLA4 axes in HCC and thus propose a clinical trial to investigate the efficacy of a novel triplet ICI combination of BC3402 plus the STRIDE regimen in participants with advanced, unresectable treatment-naïve HCC.

Conditions

• Hepato Cellular Carcinoma (HCC)

Interventions

Type	Name	Description
DRUG	BC3402	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
DRUG	Durvalumab	Durvalumab, intravenous, 1500 mg, every 4 weeks, continuous
DRUG	Tremelimumab	Tremelimumab, intravenous, 300 mg, 1 dose on Cycle 1 Day 1

Timeline

• Start date: 2025-11-01
• Primary completion: 2027-01-01
• Completion: 2028-01-01
• First posted: 2024-09-23
• Last updated: 2026-02-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study