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Not yet recruiting NCT06584071

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

Phase I / Phase II Interventional HCC Liver Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PM8002, PM1009, atezolizumab, bevacizumab.
Who it may be relevant to
Registry conditions: HCC, Liver Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase Ib/II Clinical Trial to Evaluate the Preliminary Efficacy, Safety and Pharmacokinetics of PM8002 Injection Combined With PM1009 Injection in Patients With Locally Advanced or Metastatic Hepatocellular Carcinoma

Overview

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

Detailed description

The study is divided into two parts. The first part is a phase Ib, single-arm study, which is planned to enroll 3-28 subjects.

The second part is a phase II randomized, parallel-controlled, four-arm, open-label study, which is planned to enroll approximately 120 subjects.

Interventions

  • Drug PM8002
    PM8002 via IV infusion, Q3W
  • Drug PM1009
    PM8002 via IV infusion, Q3W
  • Drug atezolizumab
    atezolizumab,1200mg, via IV infusion, Q3W
  • Drug bevacizumab
    bevacizumab,15mg/kg, via IV infusion, Q3W

Primary outcome measures

  • Objective response rate(ORR) [Time frame: Up to approximately 2 years]
  • Optimal dosing regimen of PM8002 in combination with PM1009 [Time frame: Up to approximately 2 years]
  • Treatment related adverse events (TRAEs) [Time frame: Up to 30 days after last treatment]
Secondary outcome measures (12)
  • Objective response rate(ORR)(mRECIST) [Time frame: Up to approximately 2 years]
  • Disease control rate (DCR) [Time frame: Up to approximately 2 years]
  • Duration of response (DOR) [Time frame: Up to approximately 2 years]
  • Progression free survival (PFS) [Time frame: Up to approximately 2 years]
  • Overall survival (OS) [Time frame: Up to approximately 2 years]
  • Maximum observed concentration [Cmax] [Time frame: Up to 30 days after last treatment]
  • Time to Cmax [Tmax] [Time frame: Up to 30 days after last treatment]
  • Minimum observed concentration [Cmin] [Time frame: Up to 30 days after last treatment]
  • Area under the concentration-time curve [AUC0-last] [Time frame: Up to 30 days after last treatment]
  • AUC to the end of the dosing period(AUC0-tau) [Time frame: Up to 30 days after last treatment]
  • Apparent terminal elimination half-life (t1/2) [Time frame: Up to 30 days after last treatment]
  • Anti-drug antibody (ADA) [Time frame: Up to 30 days after last treatment]

Eligibility criteria

Inclusion criteria

  • 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；
  • No prior systemic therapy for locally advanced or metastatic and/or unresectable HCC；
  • At least 1 measurable lesion ；
  • Adequate organ function；
  • ECOG score of 0 to 1；
  • Life expectancy ≥ 12 weeks;

Exclusion criteria

  • 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;
  • Current presence of uncontrolled pleural, pericardial, and peritoneal effusions;
  • History of allogeneic hematopoietic stem cell transplantation or allogeneic organ transplantation;
  • History of alcohol abuse, psychotropic substance abuse or drug abuse;
  • Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome;
  • Pregnant or lactating women;
  • Other conditions considered unsuitable for this study by the investigator.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06584071 · PM80021009-AB001C-HCC-R

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗