Health TrialsbyHealthPanel

A Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of BRII-5395 in Combination With Sintilimab and Bevacizumab in Advanced Hepatitis B Virus Related Hepatocellular Carcinoma

ConditionAdvanced HBV-Related Hepatocellular Carcinoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

About this trial

This early phase (Phase 1) study will evaluate BRII 5395, administered in combination with two approved anticancer agents, sintilimab and bevacizumab, in patients with advanced liver cancer caused by chronic hepatitis B virus (HBV) infection. The primary objective of the study is to assess the safety and tolerability of the combination therapy, as well as to explore preliminary evidence of clinical benefit.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of locally advanced or metastatic HCC that is deemed unsuitable for surgical resection or transplant.

BCLC stages Intermediate (B) or Advanced (C).

Failed at least first-line systemic therapy, including ICIs; and disease is not amenable to curative surgical and/or locoregional therapies.

Adequate bone marrow and organ function status.

Disqualifiers

Any systemic anticancer therapy within specified period prior to the first dose of study treatment.

Any localized anticancer therapy within specified period prior to the first dose of study treatment.

History of anaphylactic hypersensitivity prior to the first dose of study treatment.

Known hypersensitivity to polyethylene glycol or any component of sintilimab or bevacizumab formulation, or any contraindications to sintilimab or bevacizumab.

Trial design

Design model

Parallel

Treatments tested in this trial

  • BRII-5395

    Drug

    BRII-5395 will be given via IM injection

  • Sintilimab

    Drug

    Sintilimab will be given via IV infusion

  • Bevacizumab

    Drug

    Bevacizumab will be given via IV infusion

Treatment groups

21 Participants
are divided into 2 treatment groups
Group A: BRII-5395 dose escalationExperimental treatment 3 interventions
Group B: BRII-5395 dose expansionExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Incidence and type of dose-limiting toxicities (DLTs)

Time frame
Up to 30 days post last dose
2

Adverse events (AEs) and serious AEs (SAEs)

Time frame
Up to 30 days post last dose
3

Abnormalities in laboratory and other clinical assessments

Time frame
Up to 30 days post last dose

Secondary outcomes

1

Objective response rate (ORR)

Time frame
Up to 2 years
2

Disease control rat (DCR)

Time frame
Up to 2 years
3

Duration of response (DOR)

Time frame
Up to 2 years
4

Progression-free survival (PFS)

Time frame
Up to 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Lead sponsor

Source ClinicalTrials.gov
Apply now