A Phase 1/2 interventional study of PM8002 and PM1009 in HCC and Liver Cancer, sponsored by Biotheus Inc.. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-16.
Sponsored by Biotheus Inc. · Phase 1/2, Interventional, and Treatment
This study to evaluate the preliminary efficacy, safety and pharmacokinetics of PM8002 combined with PM1009 in Patients with first-line Hepatocellular Carcinoma.
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.
1,391 studies on the registry are indexed under Liver Neoplasms; 345 are open to participants now.
This study's planned enrollment of 140 is above the median of 47 across 968 interventional studies indexed under Liver Neoplasms.
Browse Liver Neoplasms studies →Biotheus Inc. is the lead sponsor of 17 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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
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
PM8002 via IV infusion, Q3W
PM8002 via IV infusion, Q3W
atezolizumab,1200mg, via IV infusion, Q3W
bevacizumab,15mg/kg, via IV infusion, Q3W
Objective response rate(ORR)
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
Optimal dosing regimen of PM8002 in combination with PM1009
To determine the dosing regimen of PM8002 in combination with PM1009
Time frame: Up to approximately 2 years
Treatment related adverse events (TRAEs)
The incidence and severity of TRAEs graded according to NCI-CTCAE v5.0
Time frame: Up to 30 days after last treatment
Objective response rate(ORR)(mRECIST)
ORR is the proportion of subjects with complete response (CR) or partial response (PR), based on mRECIST
Time frame: Up to approximately 2 years
Disease control rate (DCR)
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
Time frame: Up to approximately 2 years
Duration of response (DOR)
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
Time frame: Up to approximately 2 years
Progression free survival (PFS)
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
Time frame: Up to approximately 2 years
Overall survival (OS)
OS is the time from the date of randomization or first dosing date to death due to any cause
Time frame: Up to approximately 2 years
Maximum observed concentration [Cmax]
To evaluate the Cmax of Combination regimen .
Time frame: Up to 30 days after last treatment
Time to Cmax [Tmax]
To evaluate the Tmax of Combination regimen .
Time frame: Up to 30 days after last treatment
Minimum observed concentration [Cmin]
To evaluate the Cmin of Combination regimen .
Time frame: Up to 30 days after last treatment
Area under the concentration-time curve [AUC0-last]
To evaluate the AUC0-last of Combination regimen .
Time frame: Up to 30 days after last treatment
AUC to the end of the dosing period(AUC0-tau)
To evaluate the AUC0-tau of Combination regimen .
Time frame: Up to 30 days after last treatment
Apparent terminal elimination half-life (t1/2)
To evaluate the t1/2 of Combination regimen .
Time frame: Up to 30 days after last treatment
Anti-drug antibody (ADA)
To evaluate the incidence of ADA to PM8002
Time frame: Up to 30 days after last treatment
No study locations are listed for this record.
Plan to share: Yes — The data will be published or presented for publications (poster, abstract,articles or papers) or any presentations
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Biotheus Inc.