Firsekibart, Tislelizumab, Lenvatinib for TP53-Mutated HCC
ClinicalTrials.gov Studies
Summary
NIH registered Phase 2 clinical trial NCT07535840 evaluating combination therapy with Firsekibart, Tislelizumab, and Lenvatinib in patients with unresectable, TP53-mutated hepatocellular carcinoma who have failed prior systemic immunotherapy. The study's primary objective is objective response rate, with secondary objectives assessing overall efficacy, safety, and biomarker predictors.
What changed
This document registers a new Phase 2 clinical trial on ClinicalTrials.gov, describing a combination therapy study for patients with unresectable, TP53-mutated hepatocellular carcinoma. The trial will evaluate Firsekibart (monoclonal antibody), tislelizumab (PD-1 inhibitor), and lenvatinib (TKI) in patients who have failed prior systemic immunotherapy. Treatment continues until disease progression or unacceptable toxicity, with tumor response assessed by RECIST v1.1 every 6 weeks.
Affected parties including pharmaceutical sponsors, clinical investigators, and institutional review boards should note this trial's registration for protocol compliance, informed consent documentation, and adverse event reporting requirements under GxP standards.
Archived snapshot
Apr 17, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
A Clinical Trial of Firsekibart, Tislelizumab, and Lenvatinib in Patients With Unresectable, TP53-Mutated Hepatocellular Carcinoma
N/A NCT07535840 Kind: NA Apr 17, 2026
Abstract
This study aims to evaluate the effectiveness and safety of a combination therapy with Fuxinqibai monoclonal antibody, Tislelizumab, and Lenvatinib in patients with advanced, unresectable TP53-mutated hepatocellular carcinoma (HCC) who have previously failed systemic immunotherapy.
Eligible patients will receive:
Fuxinqibai 200 mg IV every 3 weeks Tislelizumab 200 mg IV every 3 weeks Lenvatinib 8 mg (≤60 kg) or 12 mg (>60 kg) orally once daily Treatment will continue until disease progression, unacceptable toxicity, start of a new anticancer therapy, withdrawal of consent, or other protocol-defined reasons. Tumor response will be evaluated by RECIST v1.1 every 6 weeks, and confirmed after 4 weeks if response is observed.
Safety will be monitored through adverse events and laboratory tests, graded according to NCI CTCAE v5.0. After treatment ends, patients will be followed every 6 weeks for tumor assessment and every 12 weeks for survival, until death, loss to follow-up, or withdrawal of consent.
Primary Objective: To assess the objective response rate (ORR) of the combination therapy.
Secondary Objectives: To evaluate overall efficacy, safety, and explore potential biomarkers predicting treatment response.
Conditions: HCC - Hepatocellular Carcinoma, TP53 Gene Mutation, Unresectable, Resistant Cancer
Interventions: Firsekibart + Tislelizumab + Lenvatinib
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