PM8002 in Combination With Chemotherapy as First Line Therapy in Hepatocellular Carcinoma

NCT ID: NCT05864105

Last Updated: 2025-03-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-22
• Study Completion Date: 2026-06-30

Brief Summary

This is a multicenter, single-arm, open-label phase II study to evaluate the efficacy and safety of PM8002 in combination with chemotherapy in the first-line treatment of subjects with inoperable HCC.

Detailed Description

PM8002 is a Bispecific Antibody Targeting PD-L1 and VEGF.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PM8002+FOLFOX-4

PM8002 20mg/kg Q2W day 1: oxaliplatin \[85 mg/m2, 2-h infusion\] plus leucovorin \[200 mg/m2, 2-h infusion\], followed by 5-fluorouracil \[400 mg/m2, intravenous bolus; 600 mg/m2, 22-h infusion\]; day 2: leucovorin \[200 mg/m2, 2-h infusion\], followed by 5-fluorouracil \[400 mg/m2, intravenous bolus; 600 mg/m2, 22-h infusion\]

Group Type: EXPERIMENTAL

PM8002

Intervention Type: BIOLOGICAL

PM8002 20mg/kg Q2W

FOLFOX regimen

Intervention Type: DRUG

day 1: oxaliplatin \[85 mg/m2, 2-h infusion\] plus leucovorin \[200 mg/m2, 2-h infusion\], followed by 5-fluorouracil \[400 mg/m2, intravenous bolus; 600 mg/m2, 22-h infusion\]; day 2: leucovorin \[200 mg/m2, 2-h infusion\], followed by 5-fluorouracil \[400 mg/m2, intravenous bolus; 600 mg/m2, 22-h infusion\]

Interventions

PM8002

PM8002 20mg/kg Q2W

Intervention Type: BIOLOGICAL

FOLFOX regimen

day 1: oxaliplatin \[85 mg/m2, 2-h infusion\] plus leucovorin \[200 mg/m2, 2-h infusion\], followed by 5-fluorouracil \[400 mg/m2, intravenous bolus; 600 mg/m2, 22-h infusion\]; day 2: leucovorin \[200 mg/m2, 2-h infusion\], followed by 5-fluorouracil \[400 mg/m2, intravenous bolus; 600 mg/m2, 22-h infusion\]

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Voluntary participation in clinical study; fully understand the study and sign informed consent voluntarily; willing to follow and able to complete all test procedures;

2. Male or female aged >= 18 years;

3. HCC diagnosed by pathology or clinical;

4. BCLC stage C or B (unresectable or/and not suitable for local therapy);

5. Child-Pugh score <= 7;

6. ECOG performance status of 0 or 1.

Exclusion Criteria

1. Histological diagnosis of fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC;

2. Symptomatic CNS metastases, not suitable for the study assessed by investigator;

3. Evidence of major coagulopathy or other obvious risk of bleeding;

4. Unable to accept enhanced imaging examination (CT or MRI) for any reason;

5. History of severe allergic disease, severe allergy to drugs or known allergy to any component of the drug in this study;

6. Human immunodeficiency virus infection or known acquired immunodeficiency syndrome;

7. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;

8. Known history of alcohol abuse, psychotropic drug abuse or drug abuse;

9. Patients with psychiatric disorders or poor compliance;

10. Women who are pregnant or breastfeeding;

11. The condition of the subject, as determined by the investigator, may increase the risk of after study treatment, or may cause confusion about the interpretation of the toxic reaction and AE;

12. Other conditions lead to inappropriate to participate in this study as judged 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

Jieer Ying

Role: PRINCIPAL_INVESTIGATOR

Cancer Hospital of The University of Chinese Academy of Sciences

Locations

Anhui Provincial Hospital

Hefei, Anhui, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Henan Cancer Hospital

Zhengzhou, Henan, China

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

The First Hospital of Jilin University

Changchun, Jilin, China

Cancer Hospital of The University of Chinese Academy of Sciences

Hangzhou, Zhejiang, China

Sir Run Run Shaw Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Jinhua Municipal Centeral Hospital Medical Group

Jinhua, Zhejiang, China

Countries

China

Other Identifiers

PM8002 -B006C-HCC-R

Identifier Type: -

Identifier Source: org_study_id