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

ConditionHCC - Hepatocellular Carcinoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorImmuneOnco Biopharmaceuticals (Shanghai) Inc.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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).

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Participants will receive IMM2510 20.0 mg/kg(Q2W), will receive IMM27M 1.0 mg/kg (Q8W)Experimental treatment 1 intervention

Trial outcomes

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.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: