Not Yet RecruitingPhase 1/2

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

140 participantsStarted 2024-12

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

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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；

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;

What they're measuring

Objective response rate(ORR)

Timeframe: Up to approximately 2 years

Optimal dosing regimen of PM8002 in combination with PM1009

Timeframe: Up to approximately 2 years

Treatment related adverse events (TRAEs)

Timeframe: Up to 30 days after last treatment

Trial details

NCT IDNCT06584071

SponsorBiotheus Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-10

Contact for this trial

Xuelian Xing

+86 021 32120207 xing.xl@biotheus.com

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