PM8002 in the Treatment of Patients With Advanced Solid Tumors
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
1 other identifier
interventional
380
1 country
48
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2021
Longer than P75 for phase_1
48 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 9, 2021
CompletedFirst Submitted
Initial submission to the registry
May 30, 2023
CompletedFirst Posted
Study publicly available on registry
June 26, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2025
CompletedDecember 5, 2024
November 1, 2024
4.7 years
May 30, 2023
December 3, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
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.
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
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.
Up to approximately 2 years
Secondary Outcomes (5)
Disease control rate (DCR)
Up to approximately 2 years
Duration of response (DoR)
Up to approximately 2 years
Overall survival (OS)
Up to approximately 2 years
Progression-free survival (PFS)
Up to approximately 2 years
Anti-drug antibody (ADA)
Up to 30 days after last treatment
Study Arms (1)
PM8002
EXPERIMENTALPM8002 IV every 2 weeks(q2w) or every 3 weeks(q3w)
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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;
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biotheus Inc.lead
Study Sites (48)
Baoji Central Hospital
Baoji, China
Baoji Central Hospital
Baoji, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, China
Peking University Cancer Hospital
Beijing, China
Peking University Cancer Hospital
Beijing, China
Jilin Cancer Hospital
Changchun, China
The First Hospital of Jilin University
Changchun, China
Changde First People's Hospital
Changde, China
Hunan Provincial People's Hospital
Changsha, China
The First People's Hospital of Changzhou
Changzhou, China
Chengdu Integrated TCM& Western Medicine Hospital
Chengdu, China
Sichuan Cancer Hospital
Chengdu, China
Chongqing Cancer Hospital
Chongqing, China
Chongqing Cancer Hospital
Chongqing, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, China
The Southwest Hospital of AMU
Chongqing, China
Fujian Cancer Hospital
Fuzhou, China
Fujian Cancer Hospital
Fuzhou, China
Zhejiang Provincial People's Hospital
Hangzhou, China
Harbin Medical University Cancer Hospital
Harbin, China
Anhui Provincial Hospital
Hefei, China
Linyi Cancer Hospital
Linyi, China
Jiangsu Province Hospital
Nanjing, China
Jiangsu Province Hospital
Nanjing, China
Shanghai Orient Hospital
Shanghai, China
Shanghai Sixth People's Hospital
Shanghai, China
Shengjing Hospital of China Medical University
Shengjing, China
Liaoning Cancer Hospital
Shenyang, China
The First Hospital of China Medical University
Shenyang, China
The People's Hospital of Liaoning Province
Shenyang, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, China
Shanxi Bethune Hospital
Taiyuan, China
Shanxi Provincial Cancer Hospital
Taiyuan, China
Shanxi Provincial Cancer Hospital
Taiyuan, China
Taizhou Hospital of Zhejiang Province
Taizhou, China
The Second Hospital of Tianjin Medical University
Tianjin, China
Hubei Cancer Hospital
Wuhan, China
Hubei Cancer Hospital
Wuhan, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China
Xi 'an International Medical Center Hospital
Xi'an, China
Xi 'an International Medical Center Hospital
Xi'an, China
Yantai Yuhuangding Hospital
Yantai, China
Yibin Second People's Hospital
Yibin, China
Henan Cancer Hospital
Zhengzhou, China
The first affilated hospital of zhengzhou university
Zhengzhou, China
The first affilated hospital of zhengzhou university
Zhengzhou, China
Zhujiang Hospital of Southern Medical University
Zhujiang, China
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Ye Guo
Shanghai Orient Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 30, 2023
First Posted
June 26, 2023
Study Start
March 9, 2021
Primary Completion
November 30, 2025
Study Completion
November 30, 2025
Last Updated
December 5, 2024
Record last verified: 2024-11
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.
The data will be published or presented for publications (poster, abstract, articles or papers) or any presentations.