Clinical trial · Interventional
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
NCT06584071CI-TRIAL-00083793not yet recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study to evaluate the preliminary efficacy, safety and pharmacokinetics of PM8002 combined with PM1009 in Patients with first-line Hepatocellular Carcinoma.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HCC | Liver Neoplasm | PROBABILISTIC | 0.70 |
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| atezolizumab | Drug | Atezolizumab | ALIAS |
| bevacizumab | Drug | Bevacizumab | ALIAS |
| PM1009 | Drug | — | UNRESOLVED |
| PM8002 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Cohort 1- combination treatment
- description
- Combination regimen:PM8002 combined with PM1009. The drugs are administered on the first day every 3 weeks (Q3W), until disease progression or intolerable toxicity or patient withdrawal or study discontinuation(Whichever occurs first).
- interventionNames
- Drug: PM8002
- Drug: PM1009
- type
- EXPERIMENTAL
- label
- Cohort 2- combination treatment
- description
- Combination regimen:PM8002 combined with PM1009(low dose). The drugs are administered on the first day every 3 weeks (Q3W), until disease progression or intolerable toxicity or patient withdrawal or study discontinuation(Whichever occurs first).
- interventionNames
- Drug: PM8002
- Drug: PM1009
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.