Clinical trial NCT06584071: A Study to Evaluate of PM8002 Combined With PM1009 in Patients With First-line HCC
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: HCC
Liver Cancer
Keywords: first line
HCC
PM1009
PM8002
Lead sponsor: Biotheus Inc.
Sponsor class: INDUSTRY
First posted: 2024-09-04
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

1. Voluntary participation in clinical studies;
2. Male or female, aged ≥ 18 years;
3. Pathologically or clinically confirmed (according to AASLD), unresectable locally advanced and/or metastatic HCC;
4. Child-Pugh liver function score ≤7；
5. No prior systemic therapy for locally advanced or metastatic and/or unresectable HCC；
6. At least 1 measurable lesion ；
7. Adequate organ function；
8. ECOG score of 0 to 1；
9. Life expectancy ≥ 12 weeks;

Exclusion Criteria:

1. Pathologically confirmed fibrolamellar HCC, sarcomatoid HCC, cholangiocarcinoma and other components；
2. History of serious allergic diseases；
3. The toxicity of previous anti-tumor therapy has not been alleviated；
4. History of severe cardiovascular diseases within 6 months;
5. Current presence of uncontrolled pleural, pericardial, and peritoneal effusions;
6. History of allogeneic hematopoietic stem cell transplantation or allogeneic organ transplantation;
7. History of alcohol abuse, psychotropic substance abuse or drug abuse;
8. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome;
9. Pregnant or lactating women;
10. Other conditions considered unsuitable for this study by the investigator.

Primary outcomes:
measure: Objective response rate(ORR)
timeFrame: Up to approximately 2 years
measure: Optimal dosing regimen of PM8002 in combination with PM1009
timeFrame: Up to approximately 2 years
measure: Treatment related adverse events (TRAEs)
timeFrame: Up to 30 days after last treatment
Secondary outcomes:
measure: Objective response rate(ORR)(mRECIST)
timeFrame: Up to approximately 2 years
measure: Disease control rate (DCR)
timeFrame: Up to approximately 2 years
measure: Duration of response (DOR)
timeFrame: Up to approximately 2 years
measure: Progression free survival (PFS)
timeFrame: Up to approximately 2 years
measure: Overall survival (OS)
timeFrame: Up to approximately 2 years
measure: Maximum observed concentration [Cmax]
timeFrame: Up to 30 days after last treatment
measure: Time to Cmax [Tmax]
timeFrame: Up to 30 days after last treatment
measure: Minimum observed concentration [Cmin]
timeFrame: Up to 30 days after last treatment
measure: Area under the concentration-time curve [AUC0-last]
timeFrame: Up to 30 days after last treatment
measure: AUC to the end of the dosing period(AUC0-tau)
timeFrame: Up to 30 days after last treatment
measure: Apparent terminal elimination half-life (t1/2)
timeFrame: Up to 30 days after last treatment
measure: Anti-drug antibody (ADA)
timeFrame: Up to 30 days after last treatment
Other outcomes:
Locations:
Study officials:
affiliation: Zhong Shan Hospital, Fudan University
name: Jia Fan
role: PRINCIPAL_INVESTIGATOR
References: