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A Phase II, Randomized, Open-label, Multi-center Study of AK104 in Combination with Lenvatinib versus Lenvatinib in Participants with Advanced Hepatocellular Carcinoma Who Have Progressed on Atezolizumab and Bevacizumab

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-524591-30-00
Enrollment
37
Registered
2026-08-18
Start date
Unknown
Completion date
Unknown
Last updated
2026-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Brief summary

ORR per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1) by Blinded Independent Central Review (BICR).

Detailed description

OS, PFS, DoR, DCR and TTR per RECIST v1.1 by BICR., PFS, ORR, DoR, DCR and TTR per RECIST v1.1 by investigator., Safety assessment: incidence and severity of adverse events (AE), abnormal laboratory examinations, vital signs, and electrocardiogram (ECG)., Pharmacokinetic profile: serum concentrations of AK104 in individual participants at different time points after AK104 administration., Immunogenicity assessment: number and percentage of participants with detectable ADA.

Interventions

DRUGLENVIMA 4 mg hard capsules
DRUGCadonilimab

Sponsors

Akeso Biopharma Co. Ltd.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
ORR per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1) by Blinded Independent Central Review (BICR).—

Secondary

MeasureTime frame
OS, PFS, DoR, DCR and TTR per RECIST v1.1 by BICR., PFS, ORR, DoR, DCR and TTR per RECIST v1.1 by investigator., Safety assessment: incidence and severity of adverse events (AE), abnormal laboratory examinations, vital signs, and electrocardiogram (ECG)., Pharmacokinetic profile: serum concentrations of AK104 in individual participants at different time points after AK104 administration., Immunogenicity assessment: number and percentage of participants with detectable ADA.—

Outcome results

None listed

Source: EU CTIS · Data processed: Aug 20, 2026