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NCT Number: NCT07687914

A Study of IMM2510 + IMM27M Combination Therapy in Patients With Advanced Hepatocellular Carcinoma

This is a Phase 2, open-label, multicenter,study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of IMM2510(Anti-PD-L1 and VEGF trap recombinant - Page 1 of 5 - protein) combine with IMM27M(Anti-CTLA-4 Humanized monoclonal antibody) in patients with advanced hepatocellular carcinoma who not have received the treatment for aHCC in past

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Key information

Conditions

HCC - Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Participant has provided informed consent prior to initiation of any study specific activities/procedures.

  • Age greater than or equal to 18 years old and ≤ 75 years old at the same time of signing the informed consent.
  • Histologically or cytologically confirmed for HCC
  • Eastern Cooperative Oncology Group (ECOG) 0 to 1.
  • Adequate organ function as defined in protocol.

Exclusion criteria

  • History of other malignancy within the past 5 years with exceptions.
  • Systemic chemotherapy was administered within 4 weeks prior to the first administration.
  • Activated symptomatic brain metastases and leptomeningeal disease.
  • History of hepatic encephalopathy disease in past 12 months.
  • Participants with symptoms and/or clinical signs and/or uncontrolled active systemic infection within 14 days prior to the first dose of study treatment. Participant has known active infection requiring parenteral antibiotic treatment.

Treatment and study plan

IMM2510, IMM27M

Drug

Biological/Vaccine: IMM2510 IMM2510 administered intravenously once every 2 weeks ( 20 mg/kg Q2W). Biological/Vaccine: IMM01 IMM01 administered intravenously once every 2 weeks ( 1 mg/kg Q8W).

Primary outcomes

  1. Objective Response Rate (ORR)

    Time frame: From date of first dose until the date of first documented progression, death from any cause, loss of follow-up, withdrawal of informed consent, or study termination by the sponsor, whichever came first, assessed up to approximately 2 years

Secondary outcomes

  1. Disease Control Rate(DCR)

    Time frame: From date of first dose until the date of first documented progression, death from any cause, loss of follow-up, withdrawal of informed consent, or study termination by the sponsor, whichever came first, assessed up to approximately 2 years

  2. Duration of Response (DOR)

    Time frame: From date of first dose until the date of first documented progression, death from any cause, loss of follow-up, withdrawal of informed consent, or study termination by the sponsor, whichever came first, assessed up to approximately 2 years

  3. Progression- Free Survival(PFS)

    Time frame: From date of first dose until the date of first documented progression, death from any cause, loss of follow-up, withdrawal of informed consent, or study termination by the sponsor, whichever came first, assessed up to approximately 2 years.

  4. Overall Survival(OS)

    Time frame: From date of first dose until the date of first documented progression, death from any cause, loss of follow-up, withdrawal of informed consent, or study termination by the sponsor, whichever came first, assessed up to approximately 2 years.

  5. Incidence and characteristics of AEs and SAEs (according to NCI CTCAE 5.0)

    Time frame: From the first dose to 30 days after the last dose [90 days for SAEs and Immune-related Adverse Event (irAEs) ], or until beginning new anti-tumor treatment

  6. Maximum Plasma Concentration [Cmax]

    Time frame: through study completion, an average of 1 year

  7. Area Under the Curve from time 0 to time t（AUC0-t）

    Time frame: through study completion, an average of 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Lianxin Liu

CONTACT

[email protected]

+86 0551-62284121

Sponsors and collaborators

Lead sponsor

ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

Other

Registry information

Official study title

Phase II Clinical Study of IMM2510 for Injection Combined With IMM27M for Injection in Advanced Hepatocellular Carcinoma

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jul 7, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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