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

NCT06584071 | Not Yet Recruiting Phase 1

• 1 other identifier: PM80021009-AB001C-HCC-R
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study to evaluate the preliminary efficacy, safety and pharmacokinetics of PM8002 combined with PM1009 in Patients with first-line Hepatocellular Carcinoma.

Conditions

HCC; Liver Cancer

Keywords

first line; HCC; PM1009; PM8002

Outcome Measures

Primary Outcomes (3)

• Objective response rate(ORR)

  ORR is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1.

  Up to approximately 2 years

• Optimal dosing regimen of PM8002 in combination with PM1009

  To determine the dosing regimen of PM8002 in combination with PM1009

  Up to approximately 2 years

• Treatment related adverse events (TRAEs)

  The incidence and severity of TRAEs graded according to NCI-CTCAE v5.0

  Up to 30 days after last treatment

Secondary Outcomes (12)

• Objective response rate(ORR)(mRECIST)

  Up to approximately 2 years

• Disease control rate (DCR)

  Up to approximately 2 years

• Duration of response (DOR)

  Up to approximately 2 years

• Progression free survival (PFS)

  Up to approximately 2 years

• Overall survival (OS)

  Up to approximately 2 years

Study Arms (4)

Cohort 1- combination treatment

EXPERIMENTAL

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).

Drug: PM8002; Drug: PM1009

Cohort 2- combination treatment

EXPERIMENTAL

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).

Drug: PM8002; Drug: PM1009

Cohort 3- monotherapy

EXPERIMENTAL

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).

Drug: PM8002

Cohort 4

ACTIVE COMPARATOR

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).

Drug: atezolizumab; Drug: bevacizumab

Interventions

PM8002 DRUG

PM8002 via IV infusion, Q3W

Cohort 1- combination treatment; Cohort 2- combination treatment; Cohort 3- monotherapy

PM1009 DRUG

PM8002 via IV infusion, Q3W

Cohort 1- combination treatment; Cohort 2- combination treatment

atezolizumab DRUG

atezolizumab,1200mg, via IV infusion, Q3W

Cohort 4

bevacizumab DRUG

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

Cohort 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntary participation in clinical studies;
• Male or female, aged ≥ 18 years;
• Pathologically or clinically confirmed (according to AASLD), unresectable locally advanced and/or metastatic HCC;
• Child-Pugh liver function score ≤7；
• No prior systemic therapy for locally advanced or metastatic and/or unresectable HCC；
• At least 1 measurable lesion ；
• Adequate organ function；
• ECOG score of 0 to 1；
• Life expectancy ≥ 12 weeks;

You may not qualify if:

• Pathologically confirmed fibrolamellar HCC, sarcomatoid HCC, cholangiocarcinoma and other components；
• History of serious allergic diseases；
• The toxicity of previous anti-tumor therapy has not been alleviated；
• History of severe cardiovascular diseases within 6 months;
• Current presence of uncontrolled pleural, pericardial, and peritoneal effusions;
• History of allogeneic hematopoietic stem cell transplantation or allogeneic organ transplantation;
• History of alcohol abuse, psychotropic substance abuse or drug abuse;
• Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome;
• Pregnant or lactating women;
• Other conditions considered unsuitable for this study by the investigator.

Sponsors & Collaborators

• Biotheus Inc.: lead

MeSH Terms

Conditions

Liver Neoplasms

Interventions

atezolizumab; Bevacizumab

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Jia Fan

  Zhong Shan Hospital, Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xuelian Xing

CONTACT

+86 021 32120207; xing.xl@biotheus.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: September 4, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: After the trial completed
• Access Criteria: NCI is committed to sharing data in accordance with NIH policy.