Malignant NeoplasmPhase 1/2NCT05918445
PM8002 in the Treatment of Patients With Advanced Solid Tumors
A Phase 1/2 study testing PM8002 in people with Malignant Neoplasm, run by Biotheus Inc. at 48 sites in China.
Trial summary
This study is to characterize the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and anti-tumor activity of PM8002, a PD-L1/VEGF bispecific antibody, as a single agent in adult subjects with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Malignant Neoplasm
- What is being tested?
- PM8002
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 48 sitesChina
- Study dates
- 9 Mar 2021to 30 Nov 2025
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 to 75 years;
- Patients with malignant tumor confirmed by histology or cytology;
- The toxicity of previous anti-tumor therapy has not been alleviated；
- Adequate organ function；
- ECOG score was 0-1;
- Expected survival >=12 weeks;
- According to RECIST 1.1 criteria, at least 1 measurable lesion that has not been previously treated locally.
Who cannot join
- History of severe allergic disease, severe allergy to drugs or known allergy to any component of the drug in this study;
- Evidence of major coagulopathy or other obvious risk of bleeding;
- Patients are experiencing a clear interstitial lung disease or non-infectious pneumonia, unless it is caused by local radiotherapy;
- Patients with uncontrolled brain metastases should be excluded from this clinical trial;
- Patients ever experienced other active malignant tumors within 5 years prior to the study treatment;
- Prior allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
Show all 11Show fewer
- Known history of alcohol abuse, psychotropic drug abuse or drug abuse;
- Syphilis antibody positive;
- Patients with active tuberculosis (TB) are excluded;
- Pregnant or lactating women;
- Other conditions lead to inappropriate to participate in this study as judged by the investigator.
Trial locations and contacts
48 sites in 1 country. Contact the study team or a site near you to ask about taking part.
48 sites in 1 country
China48 sites, 48 recruiting
- Recruiting
Baoji Central Hospital
Baoji
Yaning Zhao
Yaning Zhao
- Recruiting
Baoji Central Hospital
Baoji
Gang Wang
Gang Wang
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing
Lingying Wu
Lingying Wu
- Recruiting
Peking University Cancer Hospital
Beijing
Jun Guo
Jun Guo
- Recruiting
Peking University Cancer Hospital
Beijing
Lin Shen
Lin Shen
- Recruiting
Jilin Cancer Hospital
Changchun
Yng Cheng
Ying Cheng
- Recruiting
The First Hospital of Jilin University
Changchun
Jiuwei Cui
Jiuwei Cui
- Recruiting
Changde First People's Hospital
Changde
Tao Wu
Tao Wu
- Recruiting
Hunan Provincial People's Hospital
Changsha
Huaxin Duan
Huaxin Duan
- Recruiting
The First People's Hospital of Changzhou
Changzhou
Mei Ji
Mei Ji
- Recruiting
Chengdu Integrated TCM& Western Medicine Hospital
Chengdu
Ping Li
Ping Li
- Recruiting
Sichuan Cancer Hospital
Chengdu
Yongdong Jin
Yongdong Jin
- Recruiting
Chongqing Cancer Hospital
Chongqing
Yongsheng Li
Yongsheng Li
- Recruiting
Chongqing Cancer Hospital
Chongqing
Hong Luo
Hong Luo
- Recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing
Chengyou Du
Chengyou Du
- Recruiting
The Southwest Hospital of AMU
Chongqing
Zhiqing Liang
Zhiqing Liang
- Recruiting
Fujian Cancer Hospital
Fuzhou
An Lin
An An
- Recruiting
Fujian Cancer Hospital
Fuzhou
Yu Chen
Yu Chen
- Recruiting
Zhejiang Provincial People's Hospital
Hangzhou
Zhiquan Qin
Zhiquan Qin
- Recruiting
Harbin Medical University Cancer Hospital
Harbin
Baogang Liu
Baogang Liu
- Recruiting
Anhui Provincial Hospital
Hefei
Yueyin pan
Yueyin pan
- Recruiting
Linyi Cancer Hospital
Linyi
Jingfen Wang
Zhen Wang
- Recruiting
Jiangsu Province Hospital
Nanjing
Yongmei Yin
Yongmei Yin
- Recruiting
Jiangsu Province Hospital
Nanjing
Zengjun Wang
Zengjun Wang
- Recruiting
Shanghai Orient Hospital
Shanghai
Ye Guo, 13501678472, pattrickguo@gmail.com
Ye Guo
- Recruiting
Shanghai Sixth People's Hospital
Shanghai
Hun Zhao
Hun Zhao
- Recruiting
Shengjing Hospital of China Medical University
Shengjing
Bin Wu
Bin Wu
- Recruiting
Liaoning Cancer Hospital
Shenyang
Chunyan Wang
Chunyan Wang
- Recruiting
The First Hospital of China Medical University
Shenyang
Funan Liu
Funan Liu
- Recruiting
The People's Hospital of Liaoning Province
Shenyang
Lijie He
Lijie He
- Recruiting
The Fourth Hospital of Hebei Medical University
Shijiazhuang
Da Jiang
Da Jiang
- Recruiting
Shanxi Bethune Hospital
Taiyuan
Huijing Feng
Huijing Feng
- Recruiting
Shanxi Provincial Cancer Hospital
Taiyuan
Yusheng Wang
Yusheng Wang
- Recruiting
Shanxi Provincial Cancer Hospital
Taiyuan
Shuqing Wei
Shuqing Wei
- Recruiting
Taizhou Hospital of Zhejiang Province
Taizhou
Dongqing Lv
Dongqing Lv
- Recruiting
The Second Hospital of Tianjin Medical University
Tianjin
Gang Li
Gang Li
- Recruiting
Hubei Cancer Hospital
Wuhan
Feng Zhang
Feng Zhang
- Recruiting
Hubei Cancer Hospital
Wuhan
Yi Huang
Yi Huang
- Recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan
Guiling Li
Guiling Li
- Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an
Ruifang An
Ruifang An
- Recruiting
Xi 'an International Medical Center Hospital
Xi'an
Xinpeng Han
Xinpeng Han
- Recruiting
Xi 'an International Medical Center Hospital
Xi'an
Kejun Nan
Kejun Nan
- Recruiting
Yantai Yuhuangding Hospital
Yantai
Jitao Wu
Jitao Wu
- Recruiting
Yibin Second People's Hospital
Yibin
Kaijian Lei
Kaijian Lei
- Recruiting
Henan Cancer Hospital
Zhengzhou
Suxia Luo
Suxia Luo
- Recruiting
The first affilated hospital of zhengzhou university
Zhengzhou
Yanru Qin
Yanru Qin
- Recruiting
The first affilated hospital of zhengzhou university
Zhengzhou
Xingya Li
Xingya Li
- Recruiting
Zhujiang Hospital of Southern Medical University
Zhujiang
Jian Zhang
Jian Zhang
About this study
Official title: Phase Ib/IIa Safety and Efficacy of PM8002, a Bispecific Antibody Targeting PD-L1 and VEGF-A, as a Monotherapy in Patients With Advanced Solid Tumors
This study is to characterize the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and anti-tumor activity of PM8002, a PD-L1/VEGF bispecific antibody, as a single agent in adult subjects with advanced solid tumors.
- Conditions
- Malignant Neoplasm
- Being tested
- PM8002
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PM8002Drug
IV infusion
| Study group | Role | What they receive |
|---|---|---|
| PM8002 | Experimental | PM8002 IV every 2 weeks(q2w) or every 3 weeks(q3w) Receives: Drug: PM8002 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with DLTs
DLTs will be assessed during the dose-escalation phase and are defined as toxicities that meet pre-defined severity criteria and assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, intercurrent illness, or concomitant medications that occurs within the first cycle (3weeks) of treatment.
Measured: During the first three weeks of treatment with PM8002
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
Objective response rate (ORR)
Objective response rate (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
Secondary outcomes (5)
Disease control rate (DCR)
DCR is defined as the proportion of subjects with CR, PR, or stable disease(SD) based on RECIST v1.1.
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 (based on RECIST v1.1). for subjects with no documented disease progression, the deadline is the data of the last examination.
Measured: Up to approximately 2 years
Overall survival (OS)
OS is the time from the date of first dosing date to death due to any cause.
Measured: Up to approximately 2 years
Progression-free survival (PFS)
Progression-free survival is defined as the time from the start of treatment with PM8002 until the first documentation of disease progression or death due to any cause, whichever occurs first.
Measured: Up to approximately 2 years
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 posted26 Jun 2023
- Study start9 Mar 2021
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant NeoplasmStudies 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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biotheus Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ye Guo, Principal investigator, Shanghai Orient Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05918445
- Sponsor's protocol ID
- PM8002-A001
- Status last verified
- Nov 2024
- First submitted
- 30 May 2023
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- 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 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib/IIa Safety and Efficacy of PM8002, a Bispecific Antibody Targeting PD-L1 and VEGF-A, as a Monotherapy in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05918445
- Acronym / sponsor ID
- PM8002-A001
- Conditions
- Malignant Neoplasm
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- Biotheus Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Mar 2021 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 26 Jun 2023 (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 is to characterize the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and anti-tumor activity of PM8002, a PD-L1/VEGF bispecific antibody, as a single agent in adult subjects with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PM8002 | Experimental | Drug: PM8002PM8002 IV every 2 weeks(q2w) or every 3 weeks(q3w) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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 to 75 years;
- Patients with malignant tumor confirmed by histology or cytology;
- The toxicity of previous anti-tumor therapy has not been alleviated；
- Adequate organ function；
Key exclusion criteria (11 listed)
- History of severe allergic disease, severe allergy to drugs or known allergy to any component of the drug in this study;
- Evidence of major coagulopathy or other obvious risk of bleeding;
- Patients are experiencing a clear interstitial lung disease or non-infectious pneumonia, unless it is caused by local radiotherapy;
- Patients with uncontrolled brain metastases should be excluded from this clinical trial;
- Patients ever experienced other active malignant tumors within 5 years prior to the study treatment;
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 |
|---|---|---|
| PM8002IV infusion | Drug | PM8002 |
Primary outcome
Number of participants with DLTs
Time frame: During the first three weeks of treatment with PM8002
DLTs will be assessed during the dose-escalation phase and are defined as toxicities that meet pre-defined severity criteria and assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, intercurrent illness, or concomitant medications that occurs within the first cycle (3weeks) of treatment.
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
Objective response rate (ORR)
Time frame: Up to approximately 2 years
Objective response rate (ORR) is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1.
5 secondary outcomes
Disease control rate (DCR)
Time frame: Up to approximately 2 years
Duration of response (DoR)
Time frame: Up to approximately 2 years
Overall survival (OS)
Time frame: Up to approximately 2 years
Progression-free survival (PFS)
Time frame: Up to approximately 2 years
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 5 Dec 2024.
- Individual participant dataSharing planned: Yes. The data will be published or presented for publications (poster, abstract, articles or papers) or any presentations.
Related trials for Malignant Neoplasm
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Not yet recruiting
Augmented-Reality ICG Fluorescence Second-Look for Residual Nodal Disease After Axillary Dissection in Breast Cancer
Breast Cancer, Breast Neoplasms
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
RecruitingPhase 3
Somatostatin Analogues vs. Observation After Peptide Receptor Radionuclide Therapy (PRRT) in Nonfunctional Neuroendocrine Neoplasms
Neuroendocrine Neoplasm, Gastroenteropancreatic Neuroendocrine Neoplasm
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.
Ye Guo principal investigator
Shanghai Orient Hospital
48 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PM8002 in people with Malignant Neoplasm, run by Biotheus Inc. at 48 sites in China.
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 8 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Ye Guo (135 0167 8472, pattrickguo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with DLTs (time frame: During the first three weeks of treatment with PM8002). 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 5 Dec 2024.