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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Union Hospital Tongji Medical College Huazhong University of Science And Technology
RECRUITING
Wuhan
Contact Information
Primary
Ting Liu, M.D.
clinicaltrials@akesobio.com
(0760)89873999
Time Frame
Start Date: 2025-07-18
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 100
Treatments
Experimental: Cohort 1（Safety Lead-In Phase）
AK104 10mg/kg Q3W+TT-00420 10mg PO QD （n=3-6）
Experimental: Cohort 2（Safety Lead-In Phase）
AK112 20mg/kg Q3W + TT-00420 10mg PO QD（n=3-6）
Experimental: Cohort A（Expansion Cohort Phase）
AK104 10mg/kg Q3W + TT-00420 10mg PO QD（n=20-30）
Experimental: Cohort B（Expansion Cohort Phase）
AK112 20mg/kg Q3W + TT-00420 10mg PO QD（n=20-30）
Experimental: Cohort C（Expansion Cohort Phase）
TT-00420 10mg PO QD（n=20-30）
Related Therapeutic Areas
Liver Cancer
Sponsors
Leads: Akeso
Collaborators: TransThera Sciences (Nanjing), Inc.

This content was sourced from clinicaltrials.gov

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