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

NCT ID: NCT06584071

Last Updated: 2024-12-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-31
• Study Completion Date: 2027-12-31

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.

Conditions

HCC; Liver Cancer

Keywords

first line; HCC; PM1009; PM8002

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1- combination treatment

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).

Group Type: EXPERIMENTAL

PM8002

Intervention Type: DRUG

PM8002 via IV infusion, Q3W

PM1009

Intervention Type: DRUG

PM8002 via IV infusion, Q3W

Cohort 2- combination treatment

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).

Group Type: EXPERIMENTAL

PM8002

Intervention Type: DRUG

PM8002 via IV infusion, Q3W

PM1009

Intervention Type: DRUG

PM8002 via IV infusion, Q3W

Cohort 3- monotherapy

PM8002 administered on the first day every 3 weeks (Q3W), until disease progression or intolerable toxicity or patient withdrawal or study discontinuation(Whichever occurs first).

Group Type: EXPERIMENTAL

PM8002

Intervention Type: DRUG

PM8002 via IV infusion, Q3W

Cohort 4

Combination regimen：atezolizumab combined with bevacizumab. 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).

Group Type: ACTIVE_COMPARATOR

atezolizumab

Intervention Type: DRUG

atezolizumab,1200mg, via IV infusion, Q3W

bevacizumab

Intervention Type: DRUG

bevacizumab,15mg/kg, via IV infusion, Q3W

Interventions

PM8002

PM8002 via IV infusion, Q3W

Intervention Type: DRUG

PM1009

PM8002 via IV infusion, Q3W

Intervention Type: DRUG

atezolizumab

atezolizumab,1200mg, via IV infusion, Q3W

Intervention Type: DRUG

bevacizumab

bevacizumab,15mg/kg, via IV infusion, Q3W

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biotheus Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jia Fan

Role: PRINCIPAL_INVESTIGATOR

Zhong Shan Hospital, Fudan University

Central Contacts

Xuelian Xing

Role: CONTACT

Phone: +86 021 32120207

Email: xing.xl@biotheus.com

Other Identifiers

PM80021009-AB001C-HCC-R

Identifier Type: -

Identifier Source: org_study_id