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

Primary Purpose

Hepatocellular Carcinoma

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
PM8002
FOLFOX regimen
Sponsored by
Biotheus Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring PD-L1/VEGF, FOLFOX-4

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Cancer Hospital of The University of Chinese Academy of SciencesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PM8002+FOLFOX-4

Arm Description

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]

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 9, 2023
Last Updated
May 19, 2023
Sponsor
Biotheus Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05864105
Brief Title
PM8002 in Combination With Chemotherapy as First Line Therapy in Hepatocellular Carcinoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 22, 2022 (Actual)
Primary Completion Date
June 30, 2026 (Anticipated)
Study Completion Date
June 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biotheus Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
Detailed Description
PM8002 is a Bispecific Antibody Targeting PD-L1 and VEGF.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
PD-L1/VEGF, FOLFOX-4

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PM8002+FOLFOX-4
Arm Type
Experimental
Arm Description
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]
Intervention Type
Biological
Intervention Name(s)
PM8002
Intervention Description
PM8002 20mg/kg Q2W
Intervention Type
Drug
Intervention Name(s)
FOLFOX regimen
Intervention Description
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]
Primary Outcome Measure Information:
Title
Objective Response Rate
Description
Objective response rate (ORR) is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1.
Time Frame
Up to approximately 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Linlin Fan
Phone
+86 18612186005
Email
fan.ll@biotheus.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jieer Ying
Organizational Affiliation
Cancer Hospital of The University of Chinese Academy of Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Hospital of The University of Chinese Academy of Sciences
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiangdong Cheng
Phone
+86 571 88888888
Email
Chengxd516@126.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data will be published or presented for publications (poster, abstract, articles or papers) or any presentations.

Learn more about this trial

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

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