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

Sponsor

Biotheus Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05864105

Collaborator

(none)

Enrollment

Location

Arm

50.3

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma	Biological: PM8002 Drug: FOLFOX regimen	Phase 2

Detailed Description

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

35 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Apr 22, 2022

Anticipated Primary Completion Date :

Jun 30, 2026

Anticipated Study Completion Date :

Jun 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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]	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]

Arm

Intervention/Treatment

Experimental: 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]

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]

Outcome Measures

Primary Outcome Measures

Objective Response Rate [Up to approximately 2 years]
Objective response rate (ORR) is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Voluntary participation in clinical study; fully understand the study and sign informed consent voluntarily; willing to follow and able to complete all test procedures;
Male or female aged >= 18 years;
HCC diagnosed by pathology or clinical;
BCLC stage C or B (unresectable or/and not suitable for local therapy);
Child-Pugh score <= 7;
ECOG performance status of 0 or 1.

Exclusion Criteria:

Histological diagnosis of fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC;
Symptomatic CNS metastases, not suitable for the study assessed by investigator;
Evidence of major coagulopathy or other obvious risk of bleeding;
Unable to accept enhanced imaging examination (CT or MRI) for any reason;
History of severe allergic disease, severe allergy to drugs or known allergy to any component of the drug in this study;
Human immunodeficiency virus infection or known acquired immunodeficiency syndrome;
Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
Known history of alcohol abuse, psychotropic drug abuse or drug abuse;
Patients with psychiatric disorders or poor compliance;
Women who are pregnant or breastfeeding;
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;
Other conditions lead to inappropriate to participate in this study as judged by the investigator.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cancer Hospital of The University of Chinese Academy of Sciences	Hangzhou	Zhejiang	China

Sponsors and Collaborators

Biotheus Inc.

Investigators

Principal Investigator: Jieer Ying, Cancer Hospital of The University of Chinese Academy of Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Biotheus Inc.

ClinicalTrials.gov Identifier:

NCT05864105

Other Study ID Numbers:

PM8002 -B006C-HCC-R

First Posted:

May 18, 2023

Last Update Posted:

May 22, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Biotheus Inc.

PD-L1/VEGF

FOLFOX-4

Additional relevant MeSH terms:

Carcinoma

Carcinoma, Hepatocellular

Study Results

No Results Posted as of May 22, 2023