Clinical Study of TQB2223 Injection Combined With AK105 Injection in the Treatment of Advanced Hepatocellular Carcinoma.

November 18, 2025 updated by: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Phase Ib Clinical Study Evaluating the Efficacy and Safety of TQB2223 Injection Combined With Penpulimab Injection in the Treatment of Advanced Hepatocellular Carcinoma

TQB2223 is a recombinant, fully human antibody that binds to lymphocyte activation gene-3 (LAG-3) and blocks the LAG-3/ major histocompatibility complex class II (MHC-II) interaction, thus allowing for increased T-cell proliferation and cytokine production. This is a phase Ib study aimed at evaluating the safety, tolerability, and immunogenicity characteristics of TQB2223 injection combined with AK105 injection in the treatment of advanced hepatocellular carcinoma.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150000
        • Affiliated Cancer Hospital of Harbin Medical University
    • Hubei
      • Wuhan, Hubei, China, 430079
        • Hubei Provincial Tumor Hospital
    • Hunan
      • Changsha, Hunan, China, 410031
        • Hunan Provincial Tumor Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18 to 75 years old, an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, and life expectancy ≥3 months;
  • Hepatocellular carcinoma (HCC) patients confirmed by pathological histology or cytology examination or meeting the clinical diagnostic criteria for hepatocellular carcinoma according to the American Association for the Study of Liver Diseases (AASLD) or the Diagnosis and Treatment Guidelines for Primary Liver Cancer (2022 edition);
  • Have not received any immunotherapy for advanced HCC previously;
  • Subjects with a China liver cancer staging (CNLC) of stage III [or Barcelona clinical staging of liver cancer (BCLC) of stage C], or CNLC-II (BCLC-B) subjects who are not suitable for local treatment (such as hepatic artery chemotherapy and embolization) and surgical treatment, or cannot benefit from local treatment and surgical treatment as determined by the investigators;
  • Child Pugh liver function grading: Grade A or B (≤ 7 points)
  • Subjects with advanced malignant tumors who failed standard treatment or lacked effective treatment;
  • The main organs function well;
  • Male or female patient had no plans to become pregnant and agree to voluntarily take effective contraceptive measures during the study to at least 6 months after the last dose of study drug.

Exclusion Criteria:

  • Concurrent secondary malignancy or other malignancy with no evidence of disease within 5 years prior to the first dose;
  • Within 28 days prior to the first dose, received significant surgical treatment, or with obvious traumatic injury or long-term unhealed wound or fracture;
  • Patients who experienced any bleeding or bleeding events ≥ CTC AE level 3 within 4 weeks prior to the first dose; Individuals who have experienced arterial/venous thrombosis events within 6 months prior to the first dose, such as cerebrovascular accidents, deep vein thrombosis, and pulmonary embolism; Low molecular weight heparin treatment is allowed, and antiplatelet drugs are prohibited throughout the entire study period;
  • A history of gastrointestinal bleeding such as active gastric and duodenal ulcers, persistent positive fecal occult blood, and ulcerative colitis within 6 months prior to the first dose; Or other conditions determined by investigators that may cause gastrointestinal bleeding or perforation;
  • Patients with portal hypertension and at high risk of bleeding considered by the investigators, or have been confirmed by gastroscopy to have red signs or severe esophageal and gastric varicose veins.
  • Individuals with a history of psychiatric drug abuse who are unable to quit or have mental disorders;
  • Individuals who have previously received or are preparing to undergo allogeneic bone marrow transplantation or solid organ transplantation within 6 months;
  • History of hepatic encephalopathy;
  • History of uncontrolled intercurrent illness;
  • Participants who have participated in other clinical trials of anti-tumor drugs and used other investigational anti-tumor drugs within 4 weeks prior to the first dose;
  • Unstable or serious concurrent medical conditions, as assessed by the Investigators, that would substantially increase the risk-benefit ratio of participating in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TQB2223 injection+ AK105 Injection
TQB2223 injection combined with AK105 (Penpulimab) injection, once every three weeks. 21 days as a treatment cycle.
Drug: TQB2223 injection
TQB2223 is an anti- lymphocyte activation gene-3 (LAG-3) antibody.
Drug: Penpulimab Injection
Penpulimab Injection is an anti programmed death-1 (PD-1) antibody.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100 weeks.
The percentage of subjects with Complete Response (CR) or partial response (PR) assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 and Immune-Modified Response Evaluation Criteria In Solid Tumors (iRECIST).
From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100 weeks.
Progression-free survival (PFS)
Time Frame: From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100 weeks
The time from the first dose of TQB2223 to the first occurrence of disease progression or death from any cause.
From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100 weeks
The time from the first treatment to death from any cause.
From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100 weeks
Disease control rate (DCR)
Time Frame: From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100 weeks
The proportion of subjects with Complete response (CR), Partial response (PR), or Stable Disease (SD).
From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100 weeks
Duration of Response (DOR)
Time Frame: From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100 weeks
The time from first documented response to documented disease progression or death.
From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100 weeks
Number of patients with adverse events (AEs) and/or serious adverse events (SAEs)
Time Frame: From the time of informed consent to 28 days after the last dose
Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0
From the time of informed consent to 28 days after the last dose
Immunogenicity
Time Frame: within 1 hour before dose in the 1st, 2nd, 4th, and 8th cycle. 30 and 90 days after the last dose. 21 days as a treatment cycle.
The occurence of Anti-drug antibody (ADA) after administration
within 1 hour before dose in the 1st, 2nd, 4th, and 8th cycle. 30 and 90 days after the last dose. 21 days as a treatment cycle.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2024

Primary Completion (Actual)

November 3, 2025

Study Completion (Actual)

November 3, 2025

Study Registration Dates

First Submitted

March 13, 2024

First Submitted That Met QC Criteria

March 13, 2024

First Posted (Actual)

March 20, 2024

Study Record Updates

Last Update Posted (Actual)

November 21, 2025

Last Update Submitted That Met QC Criteria

November 18, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TQB2223-AK105-Ib-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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