HCCPhase 1/2NCT06584071
A Study to Evaluate of PM8002 Combined With PM1009 in Patients With First-line HCC
A Phase 1/2 study testing PM8002, PM1009 and atezolizumab in people with HCC and Liver Cancer, run by Biotheus Inc..
Trial summary
This study to evaluate the preliminary efficacy, safety and pharmacokinetics of PM8002 combined with PM1009 in Patients with first-line Hepatocellular Carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HCC, Liver Cancer
- What is being tested?
- PM8002, PM1009 and atezolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- Dec 2024to Dec 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 ；
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- Adequate organ function；
- ECOG score of 0 to 1；
- Life expectancy ≥ 12 weeks;
Who cannot join
- 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;
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase Ib/II Clinical Trial to Evaluate the Preliminary Efficacy, Safety and Pharmacokinetics of PM8002 Injection Combined With PM1009 Injection in Patients With Locally Advanced or Metastatic Hepatocellular Carcinoma
This study to evaluate the preliminary efficacy, safety and pharmacokinetics of PM8002 combined with PM1009 in Patients with first-line Hepatocellular Carcinoma.
Read the 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.
- Conditions
- HCC, Liver Cancer
- Being tested
- PM8002, PM1009, atezolizumab, bevacizumab
- Keywords
- first line, HCC, PM1009, PM8002
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PM8002Drug
PM8002 via IV infusion, Q3W
PM1009Drug
PM8002 via IV infusion, Q3W
atezolizumabDrug
atezolizumab,1200mg, via IV infusion, Q3W
bevacizumabDrug
bevacizumab,15mg/kg, via IV infusion, Q3W
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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). Receives: 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). Receives: Drug: atezolizumab; Drug: bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate(ORR)
ORR is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1.
Measured: 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
Measured: Up to approximately 2 years
Treatment related adverse events (TRAEs)
The incidence and severity of TRAEs graded according to NCI-CTCAE v5.0
Measured: Up to 30 days after last treatment
Secondary outcomes (12)
Objective response rate(ORR)(mRECIST)
ORR is the proportion of subjects with complete response (CR) or partial response (PR), based on mRECIST
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Up to approximately 2 years
Maximum observed concentration [Cmax]
To evaluate the Cmax of Combination regimen .
Measured: Up to 30 days after last treatment
Time to Cmax [Tmax]
To evaluate the Tmax of Combination regimen .
Measured: Up to 30 days after last treatment
Minimum observed concentration [Cmin]
To evaluate the Cmin of Combination regimen .
Measured: Up to 30 days after last treatment
Area under the concentration-time curve [AUC0-last]
To evaluate the AUC0-last of Combination regimen .
Measured: 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 .
Measured: Up to 30 days after last treatment
Apparent terminal elimination half-life (t1/2)
To evaluate the t1/2 of Combination regimen .
Measured: Up to 30 days after last treatment
Anti-drug antibody (ADA)
To evaluate the incidence of ADA to PM8002
Measured: Up to 30 days after last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2024
- Study startDec 2024 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCCStudies of the same condition, open and under way.
- More trials run by Biotheus Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biotheus Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jia Fan, Principal investigator, Zhong Shan Hospital, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06584071
- Sponsor's protocol ID
- PM80021009-AB001C-HCC-R
- Status last verified
- Dec 2024
- First submitted
- 21 Aug 2024
- Last updated
- 16 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be published or presented for publications (poster, abstract,articles or papers) or any presentations
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II Clinical Trial to Evaluate the Preliminary Efficacy, Safety and Pharmacokinetics of PM8002 Injection Combined With PM1009 Injection in Patients With Locally Advanced or Metastatic Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT06584071
- Acronym / sponsor ID
- PM80021009-AB001C-HCC-R
- Conditions
- HCC, Liver Cancer
- Keywords
- first line, HCC, PM1009, PM8002
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Biotheus Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2024 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 4 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1- combination treatment | Experimental | Drug: PM8002, Drug: PM1009Combination 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). |
| Cohort 2- combination treatment | Experimental | Drug: PM8002, Drug: PM1009Combination 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). |
| Cohort 3- monotherapy | Experimental | Drug: PM8002PM8002 administered on the first day every 3 weeks (Q3W), until disease progression or intolerable toxicity or patient withdrawal or study discontinuation(Whichever occurs first). |
| Cohort 4 | Active comparator | Drug: atezolizumab, Drug: bevacizumabCombination 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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；
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PM8002PM8002 via IV infusion, Q3W | Drug | Cohort 1- combination treatment, Cohort 2- combination treatment, Cohort 3- monotherapy |
| PM1009PM8002 via IV infusion, Q3W | Drug | Cohort 1- combination treatment, Cohort 2- combination treatment |
| atezolizumabatezolizumab,1200mg, via IV infusion, Q3W | Drug | Cohort 4 |
| bevacizumabbevacizumab,15mg/kg, via IV infusion, Q3W | Drug | Cohort 4 |
Primary outcome
Objective response rate(ORR)
Time frame: 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
Time frame: Up to approximately 2 years
To determine the dosing regimen of PM8002 in combination with PM1009
Treatment related adverse events (TRAEs)
Time frame: Up to 30 days after last treatment
The incidence and severity of TRAEs graded according to NCI-CTCAE v5.0
12 secondary outcomes
Objective response rate(ORR)(mRECIST)
Time frame: Up to approximately 2 years
Disease control rate (DCR)
Time frame: Up to approximately 2 years
Duration of response (DOR)
Time frame: Up to approximately 2 years
Progression free survival (PFS)
Time frame: Up to approximately 2 years
Overall survival (OS)
Time frame: Up to approximately 2 years
Maximum observed concentration [Cmax]
Time frame: Up to 30 days after last treatment
Time to Cmax [Tmax]
Time frame: Up to 30 days after last treatment
Minimum observed concentration [Cmin]
Time frame: Up to 30 days after last treatment
Area under the concentration-time curve [AUC0-last]
Time frame: Up to 30 days after last treatment
AUC to the end of the dosing period(AUC0-tau)
Time frame: Up to 30 days after last treatment
Apparent terminal elimination half-life (t1/2)
Time frame: Up to 30 days after last treatment
Anti-drug antibody (ADA)
Time frame: Up to 30 days after last treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Individual participant dataSharing planned: Yes. The data will be published or presented for publications (poster, abstract,articles or papers) or any presentations
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jia Fan principal investigator
Zhong Shan Hospital, Fudan University
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PM8002, PM1009 and atezolizumab in people with HCC and Liver Cancer, run by Biotheus Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xuelian Xing (+86 021 32120207, xing.xl@biotheus.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate(ORR) (time frame: Up to approximately 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.