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

NCT07687914 | Not Yet Recruiting Phase 2

• 1 other identifier: Immuneonco company
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

HCC - Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  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 (7)

• Disease Control Rate(DCR)

  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

• Duration of Response (DOR)

  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

• Progression- Free Survival(PFS)

  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.

• Overall Survival(OS)

  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.

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

  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

Study Arms (1)

Participants will receive IMM2510 20.0 mg/kg(Q2W), will receive IMM27M 1.0 mg/kg (Q8W)

EXPERIMENTAL

Drug: IMM2510, IMM27M

Interventions

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).

Participants will receive IMM2510 20.0 mg/kg(Q2W), will receive IMM27M 1.0 mg/kg (Q8W)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ImmuneOnco Biopharmaceuticals (Shanghai) Inc.: lead

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

Lianxin Liu

CONTACT

+86 0551-62284121; liulx@ustc.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: July 7, 2026
• Study Start: July 23, 2026
• Primary Completion (Estimated): July 23, 2027
• Study Completion (Estimated): July 23, 2028
• Last Updated: July 7, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share