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NCT06584071Not yet recruitingPhase 1/2

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

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

Source: ClinicalTrials.gov · Last updated 16 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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

Status (registry)
Not yet recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
140 (estimated)
First submitted
21 Aug 2024
Start date
Dec 2024
Primary completion date
Oct 2026
Lead sponsor
Biotheus Inc.
NCT number
NCT06584071

What you commit to

  • Study type: Interventional · Phase 1/2
  • Planned participants: 140
  • From Dec 2024 to the primary completion date, Oct 2026
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

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

Other illness

  • History of serious allergic diseases;
  • History of severe cardiovascular diseases within 6 months;
  • 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;
  • Other conditions considered unsuitable for this study by the investigator.

Other

  • Pathologically confirmed fibrolamellar HCC, sarcomatoid HCC, cholangiocarcinoma and other components;
  • Current presence of uncontrolled pleural, pericardial, and peritoneal effusions;
  • Pregnant or lactating women;

Who the study is looking for

  • 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;

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.