HCC - Hepatocellular Carcinoma
Conditions
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
Interventions
DRUGIMM2510, IMM27M
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).
Sponsors
ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
Contacts
CONTACTLianxin Liu
Outcome results
None listed