NCT07687914Not yet recruitingPhase 2
Phase II Clinical Study of IMM2510 for Injection Combined With IMM27M for Injection in Advanced Hepatocellular Carcinoma
ImmuneOnco Biopharmaceuticals (Shanghai) Inc.0 sites50 target enrollmentStarted: July 23, 2026Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Enrollment
- 50
- Primary Endpoint
- Objective Response Rate (ORR)
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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.
Outcomes
Primary Outcomes
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
- Maximum Plasma Concentration [Cmax](through study completion, an average of 1 year)
- Area Under the Curve from time 0 to time t（AUC0-t）(through study completion, an average of 1 year)
- 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)
Investigators
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