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A Study to Evaluate of PM8002 Combined With PM1009 in Patients With First-line HCC

ConditionsHCCLiver Cancer
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBiotheus Inc.

About this trial

This study to evaluate the preliminary efficacy, safety and pharmacokinetics of PM8002 combined with PM1009 in Patients with first-line Hepatocellular Carcinoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntary participation in clinical studies;

Male or female, aged ≥ 18 years;

Pathologically or clinically confirmed (according to AASLD), unresectable locally advanced and/or metastatic HCC;

Child-Pugh liver function score ≤7；

Disqualifiers

Pathologically confirmed fibrolamellar HCC, sarcomatoid HCC, cholangiocarcinoma and other components；

History of serious allergic diseases；

The toxicity of previous anti-tumor therapy has not been alleviated；

History of severe cardiovascular diseases within 6 months;

Trial design

Design model

Parallel

Treatments tested in this trial

  • PM8002

    Drug

    PM8002 via IV infusion, Q3W

  • PM1009

    Drug

    PM8002 via IV infusion, Q3W

  • atezolizumab

    Drug

    atezolizumab,1200mg, via IV infusion, Q3W

  • bevacizumab

    Drug

    bevacizumab,15mg/kg, via IV infusion, Q3W

Treatment groups

140 Participants
are divided into 4 treatment groups
Group A: Cohort 1- combination treatmentExperimental treatment 2 interventions
Group B: Cohort 2- combination treatmentExperimental treatment 2 interventions
Group C: Cohort 3- monotherapyExperimental treatment 1 intervention
Group D: Cohort 4Active comparator 2 interventions

Trial outcomes

Primary outcomes

1

Objective response rate(ORR)

ORR is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1.

Time frame
Up to approximately 2 years
2

Optimal dosing regimen of PM8002 in combination with PM1009

To determine the dosing regimen of PM8002 in combination with PM1009

Time frame
Up to approximately 2 years
3

Treatment related adverse events (TRAEs)

The incidence and severity of TRAEs graded according to NCI-CTCAE v5.0

Time frame
Up to 30 days after last treatment

Secondary outcomes

1

Objective response rate(ORR)(mRECIST)

ORR is the proportion of subjects with complete response (CR) or partial response (PR), based on mRECIST

Time frame
Up to approximately 2 years
2

Disease control rate (DCR)

DCR is defined as the proportion of subjects with complete response (CR), partial response (PR) or stable disease (SD) based on RECIST v1.1 and mRECIST

Time frame
Up to approximately 2 years
3

Duration of response (DOR)

DOR is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first

Time frame
Up to approximately 2 years
4

Progression free survival (PFS)

PFS is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, whichever occurs first

Time frame
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.

Biotheus Inc.

Lead sponsor

Source ClinicalTrials.gov

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