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

Hepatocellular Carcinoma Clinical Trial

Official title:

A Phase II Study to Evaluate the Efficacy, Safety and Pharmacokinetics of PM8002 Injection in Combination With Standard Chemotherapy as First Line Therapy in Unresectable Hepatocellular Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05864105
• Other study ID #: PM8002 -B006C-HCC-R
• Status: Recruiting
• Phase: Phase 2
• Start date: April 22, 2022
• Est. completion date: June 30, 2026

Study information

• Verified date: May 2023
• Source: Biotheus Inc.
• Contact: Linlin Fan
• Phone: +86 18612186005
• Email: fan.ll[@]biotheus.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Biological:
• PM8002
PM8002 20mg/kg Q2W

Drug:
• 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]

Locations

Country	Name	City	State
China	Cancer Hospital of The University of Chinese Academy of Sciences	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Biotheus Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate	Objective response rate (ORR) is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1.	Up to approximately 2 years