A Phase II Clinical Study of AK104/AK112 in Combination With TT-00420 Tablet for Advanced HCC.

NCT07052253 | Recruiting Phase 2

• 1 other identifier: AK104-223
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

An Open-label, Multicenter, Phase II Clinical Study of AK104/AK112 in Combination with TT-00420 Tablet in Patients with Advanced Hepatocellular Carcinoma(HCC).

Conditions

Hepatocellular Carcinoma (HCC)

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  assessed by investigator per RECIST v1.1

  Up to 2 years

Secondary Outcomes (6)

• Progression-free survival (PFS)

  up to 2 years

• Disease control rate(DCR)

  Up to 2 years

• Duration of Response (DOR)

  Up to 2 years

• Time to Response (TTR)

  Up to 2 years

• Time to Progression (TTP)

  Up to 2 years

Study Arms (5)

Cohort 1（Safety Lead-In Phase）

EXPERIMENTAL

AK104 10mg/kg Q3W+TT-00420 10mg PO QD （n=3-6）

Drug: TT-00420 (tinengotinib); Drug: AK104

Cohort 2（Safety Lead-In Phase）

EXPERIMENTAL

AK112 20mg/kg Q3W + TT-00420 10mg PO QD（n=3-6）

Drug: TT-00420 (tinengotinib); Drug: AK112

Cohort A（Expansion Cohort Phase）

EXPERIMENTAL

AK104 10mg/kg Q3W + TT-00420 10mg PO QD（n=20-30）

Drug: TT-00420 (tinengotinib); Drug: AK104

Cohort B（Expansion Cohort Phase）

EXPERIMENTAL

AK112 20mg/kg Q3W + TT-00420 10mg PO QD（n=20-30）

Drug: TT-00420 (tinengotinib); Drug: AK112

Cohort C（Expansion Cohort Phase）

EXPERIMENTAL

TT-00420 10mg PO QD（n=20-30）

Drug: TT-00420 (tinengotinib)

Interventions

TT-00420 (tinengotinib) DRUG

oral

Cohort 1（Safety Lead-In Phase）; Cohort 2（Safety Lead-In Phase）; Cohort A（Expansion Cohort Phase）; Cohort B（Expansion Cohort Phase）; Cohort C（Expansion Cohort Phase）

AK104 DRUG

intravenous

Cohort 1（Safety Lead-In Phase）; Cohort A（Expansion Cohort Phase）

AK112 DRUG

intravenous

Cohort 2（Safety Lead-In Phase）; Cohort B（Expansion Cohort Phase）

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 and ≤ 75 years.
• Histologically or cytologically confirmed hepatocellular carcinoma, or meets the clinical diagnostic criteria for hepatocellular carcinoma.
• Barcelona Clinic Liver Cancer (BCLC) stage C; or stage B and assessed by the investigator as unsuitable for curative topical treatment.
• For cohorts A and B: No prior systemic anti-cancer treatment for hepatocellular carcinoma.
• At least one measurable lesion according to RECIST v1.1 criteria.
• Child-Pugh liver function score ≤7. ECOG performance status of 0 or 1.
• Clinically controllable HBV or HCV infection.
• Adequate organ and bone marrow function.

You may not qualify if:

• Previous histologically or cytologically confirmed fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, etc.
• Diagnosed with another malignancy within 3 years.
• History of hepatic encephalopathy.
• Presence of clinically significant pericardial effusion; symptomatic pleural effusion requiring drainage or moderate to severe ascites uncontrolled by diuretics.
• Concurrent infection with HBV and HCV.
• Presence of central nervous system metastases or meningeal metastases.
• Esophageal or gastric variceal bleeding within 6 months. Imaging (CT or MRI) shows extrahepatic metastasis invading major blood vessels or indistinct vascular boundaries, with high bleeding risk assessed by the researcher.
• Liver tumor volume exceeding 50% of total liver volume; portal vein main trunk tumor thrombus or tumor thrombus in contralateral main branch of the portal vein, or mesenteric vein tumor thrombus; presence of inferior vena cava thrombus or involvement of the heart.
• Received topical treatment for liver cancer, any systemic anti-tumor drugs, or other clinical trial drugs within 4 weeks prior to the first administration.
• Unable to swallow, or has severe gastrointestinal disease or gastrointestinal dysfunction. History of intestinal obstruction or intestinal perforation within 6 months.
• Uncontrolled hypertension, symptomatic heart failure, symptomatic or poorly controlled arrhythmia, myocarditis, cardiomyopathy, history of malignant arrhythmias.
• Participants with severe bleeding tendencies or coagulation disorders.
• Active pulmonary tuberculosis, active syphilis, or history of HIV infection.
• Severe infection within 4 weeks prior to the first administration, or received systemic anti-infective treatment within 14 days.
• Other conditions with high medical risk or secondary tumor symptoms, which, in the judgment of the researcher, make the participant unsuitable for participation in the study.

Sponsors & Collaborators

• Akeso: lead
• TransThera Sciences (Nanjing), Inc.: collaborator

Study Sites (1)

Union Hospital Tongji Medical College Huazhong University of Science And Technology

Wuhan, China, 430000, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Central Study Contacts

Ting Liu, M.D.

CONTACT

(0760)89873999; clinicaltrials@akesobio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2025
• First Posted: July 4, 2025
• Study Start: July 18, 2025
• Primary Completion (Estimated): May 10, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

CN (1)