A Phase II Study of AK104 Combination With Lenvatinib Versus Lenvatinib for Second-line HCC

NCT ID: NCT06984718

Last Updated: 2025-05-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-25
• Study Completion Date: 2027-06-30

Brief Summary

This is a Phase II, randomized, open-label, global, multi-center study to compare the efficacy and safety of AK104 in combination with lenvatinib versus lenvatinib in patients with advanced hepatocellular carcinoma who have progressed on the first line treatment of atezolizumab and bevacizumab.

Conditions

HCC; Hepatocellular Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AK104+lenvatinib

AK104 IV plus lenvatinib orally

Group Type: EXPERIMENTAL

AK104+lenvatinib

Intervention Type: BIOLOGICAL

Subjects will receive AK104+lenvatinib until disease progression

lenvatinib

lenvatinib orally

Group Type: ACTIVE_COMPARATOR

lenvatinib

Intervention Type: DRUG

Subjects will receive lenvatinib until disease progression

Interventions

AK104+lenvatinib

Subjects will receive AK104+lenvatinib until disease progression

Intervention Type: BIOLOGICAL

lenvatinib

Subjects will receive lenvatinib until disease progression

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Signed the Informed Consent Form (ICF) voluntarily.

2. Age ≥18 years at time of signing ICF.

3. Histologic or cytologic confirmation of HCC, or clinical diagnosis of HCC as per AASLD criteria.

4. BCLC stage B or C, and not suitable for curative surgical or local therapy.

5. Participants have progressed on the prior first-line systemic treatment with atezolizumab plus bevacizumab combination treatment.

6. At least one measurable lesion according to RECIST v1.1.

7. Child-Pugh Class A .

8. ECOG performance status of 0 or 1.

9. With a life expectancy of ≥3 months.

10. Adequate organ and hematologic function.

Exclusion Criteria

1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.

2. Tumor thrombus invasion of superior mesenteric vein.

3. Has a known history of, or any evidence of CNS metastases.

4. Has received anti-cancer therapy for HCC within 3 weeks prior to the first dose of study treatment.

5. Has received systemic anti-cancer therapy other than atezolizumab and bevacizumab.

6. Has participated in another clinical study within 4 weeks prior to the first dose.

7. History of liver transplantation.

8. History of hepatic encephalopathy.

9. Clinically symptomatic or recurrently drained pleural effusion, pericardial effusion, or ascites.

10. History of bleeding event due to esophageal and/or gastric varices within 6 months prior to the first dose of study treatment.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Akeso

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard S. Finn, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Medicine, University of California

Jian Zhou, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Central Contacts

Ting Liu, M.D.

Role: CONTACT

clinicaltrials@akesobio.com

(0760)89873999

Other Identifiers

AK104-225

Identifier Type: -

Identifier Source: org_study_id