NCT06111326

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
83

participants targeted

Target at P75+ for phase_1 hepatocellular-carcinoma

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2023

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

October 17, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 1, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

November 1, 2023

Status Verified

October 1, 2023

Enrollment Period

10 months

First QC Date

October 17, 2023

Last Update Submit

October 26, 2023

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (3)

  • Phase Ib: Dose Exploration Part-The incidence of dose limiting toxicity (DLT) events

    To assess the incidence of dose limiting toxicity (DLT) events at different doses of BC3402 in combination with durvalumab in the treatment of advanced HCC

    28 Days

  • Phase Ib: Dose Exploration Part-Safety

    To assess the AEs of BC3402 in combination with durvalumab in the treatment of advanced HCC.

    2 years

  • Phase II: Dose Expansion Part-objective response rate (ORR)

    To assess the ORR of BC3402 in combination with durvalumab in advanced hepatocellular carcinoma (according to RECIST v1.1)

    2 years

Study Arms (1)

BC3402+Durvalumab

EXPERIMENTAL

Subjects will receive BC3402 and Durvalumab in a treatment cycle.

Drug: BC3402 injectionDrug: Durvalumab injection

Interventions

BC3402 injectionDRUG

Intravenous infusion, once every 2 weeks, 4 weeks/cycle.

BC3402+Durvalumab
Durvalumab injectionDRUG

Intravenous infusion, once every 4 weeks, 4 weeks/cycle.

BC3402+Durvalumab

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Willing to participate in the study and sign an informed consent form;
  • Male or female aged ≥ 18 years and ≤ 75 years;
  • Patients with advanced hepatocellular carcinoma confirmed by histology or cytology, or cirrhosis which meets the clinical diagnostic criteria of hepatocellular carcinoma by the by American Association for the Study of Liver Disease (AASLD) (2018 edition);
  • ECOG performance status of 0 or 1;
  • HBV Patients with HBV infection must be treated with antiviral therapy to ensure adequate viral suppression prior to enrollment;
  • Adequate organ and marrow function;
  • Male or female subjects with childbearing potential must agree to use reliable contraceptive methods.

You may not qualify if:

  • Received local hepatic therapy within 4 weeks prior to initiation of the study drug;
  • History of hepatic encephalopathy within the past 12 months or a requirement for medications to prevent or control encephalopathy;
  • The subject has clinically significant ascites requiring therapeuticc peritonrocentesis or peritoneal drainage.
  • The subject has main portal vein thrombosis on baseline imaging;
  • Documented history of GI bleeding within the past 6 months or at a high risk of GI bleeding per the investigator's clinical judgement;
  • Current or prior use of systemic corticosteroids or other immunosuppressive agents within 2 weeks before initiation of study drug;
  • Prior treatment with any anti-TIM3 antibody;
  • Prior treatment with an anti-PD-1 or anti PD-L1 immune checkpoint inhibitor antibody (only applicable for dose expansion part).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

durvalumab

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Jia Fan, MD

    Fudan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jia Fan, MD

CONTACT

+86021-64041990fan.jia@zs-hospital.sh.cn

Tianshu Liu, MD

CONTACT

+86 13681973996liu.tianshu@zs-hospital.sh.cn

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2023

First Posted

November 1, 2023

Study Start

October 1, 2023

Primary Completion

August 1, 2024

Study Completion

May 1, 2026

Last Updated

November 1, 2023

Record last verified: 2023-10

Locations

CN(1)