HCC, Liver Cancer
Conditions
Keywords
first line, HCC, PM1009, PM8002
Brief summary
This study to evaluate the preliminary efficacy, safety and pharmacokinetics of PM8002 combined with PM1009 in Patients with first-line Hepatocellular Carcinoma.
Detailed description
The study is divided into two parts. The first part is a phase Ib, single-arm study, which is planned to enroll 3-28 subjects. The second part is a phase II randomized, parallel-controlled, four-arm, open-label study, which is planned to enroll approximately 120 subjects.
Interventions
DRUGPM8002
PM8002 via IV infusion, Q3W
DRUGPM1009
PM8002 via IV infusion, Q3W
DRUGatezolizumab
atezolizumab,1200mg, via IV infusion, Q3W
DRUGbevacizumab
bevacizumab,15mg/kg, via IV infusion, Q3W
Sponsors
Biotheus Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Voluntary participation in clinical studies; 2. Male or female, aged ≥ 18 years; 3. Pathologically or clinically confirmed (according to AASLD), unresectable locally advanced and/or metastatic HCC; 4. Child-Pugh liver function score ≤7； 5. No prior systemic therapy for locally advanced or metastatic and/or unresectable HCC； 6. At least 1 measurable lesion ； 7. Adequate organ function； 8. ECOG score of 0 to 1； 9. Life expectancy ≥ 12 weeks;
Exclusion criteria
1. Pathologically confirmed fibrolamellar HCC, sarcomatoid HCC, cholangiocarcinoma and other components； 2. History of serious allergic diseases； 3. The toxicity of previous anti-tumor therapy has not been alleviated； 4. History of severe cardiovascular diseases within 6 months; 5. Current presence of uncontrolled pleural, pericardial, and peritoneal effusions; 6. History of allogeneic hematopoietic stem cell transplantation or allogeneic organ transplantation; 7. History of alcohol abuse, psychotropic substance abuse or drug abuse; 8. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome; 9. Pregnant or lactating women; 10. Other conditions considered unsuitable for this study by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate(ORR) | Up to approximately 2 years | ORR is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1. |
| Optimal dosing regimen of PM8002 in combination with PM1009 | Up to approximately 2 years | To determine the dosing regimen of PM8002 in combination with PM1009 |
| Treatment related adverse events (TRAEs) | Up to 30 days after last treatment | The incidence and severity of TRAEs graded according to NCI-CTCAE v5.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival (PFS) | Up to approximately 2 years | PFS is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, whichever occurs first |
| Overall survival (OS) | Up to approximately 2 years | OS is the time from the date of randomization or first dosing date to death due to any cause |
| Maximum observed concentration [Cmax] | Up to 30 days after last treatment | To evaluate the Cmax of Combination regimen . |
| Time to Cmax [Tmax] | Up to 30 days after last treatment | To evaluate the Tmax of Combination regimen . |
| Objective response rate(ORR)(mRECIST) | Up to approximately 2 years | ORR is the proportion of subjects with complete response (CR) or partial response (PR), based on mRECIST |
| Area under the concentration-time curve [AUC0-last] | Up to 30 days after last treatment | To evaluate the AUC0-last of Combination regimen . |
| AUC to the end of the dosing period(AUC0-tau) | Up to 30 days after last treatment | To evaluate the AUC0-tau of Combination regimen . |
| Apparent terminal elimination half-life (t1/2) | Up to 30 days after last treatment | To evaluate the t1/2 of Combination regimen . |
| Anti-drug antibody (ADA) | Up to 30 days after last treatment | To evaluate the incidence of ADA to PM8002 |
| Minimum observed concentration [Cmin] | Up to 30 days after last treatment | To evaluate the Cmin of Combination regimen . |
| Disease control rate (DCR) | Up to approximately 2 years | DCR is defined as the proportion of subjects with complete response (CR), partial response (PR) or stable disease (SD) based on RECIST v1.1 and mRECIST |
| Duration of response (DOR) | Up to approximately 2 years | DOR is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first |
Contacts
Primary ContactXuelian Xing
Outcome results
None listed