Clinical trial NCT05918445: PM8002 in the Treatment of Patients With Advanced Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Malignant Neoplasm
Lead sponsor: Biotheus Inc.
Sponsor class: INDUSTRY
First posted: 2023-06-26
Enrollment: 380
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Voluntary participation in clinical study; fully understand the study and sign informed consent voluntarily; willing to follow and able to complete all test procedures;
2. Male or female aged 18 to 75 years;
3. Patients with malignant tumor confirmed by histology or cytology;
4. The toxicity of previous anti-tumor therapy has not been alleviated；
5. Adequate organ function；
6. ECOG score was 0-1;
7. Expected survival \>=12 weeks;
8. According to RECIST 1.1 criteria, at least 1 measurable lesion that has not been previously treated locally.

Exclusion Criteria:

1. History of severe allergic disease, severe allergy to drugs or known allergy to any component of the drug in this study;
2. Evidence of major coagulopathy or other obvious risk of bleeding;
3. Patients are experiencing a clear interstitial lung disease or non-infectious pneumonia, unless it is caused by local radiotherapy;
4. Patients with uncontrolled brain metastases should be excluded from this clinical trial;
5. Patients ever experienced other active malignant tumors within 5 years prior to the study treatment;
6. Prior allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
7. Known history of alcohol abuse, psychotropic drug abuse or drug abuse;
8. Syphilis antibody positive;
9. Patients with active tuberculosis (TB) are excluded;
10. Pregnant or lactating women;
11. Other conditions lead to inappropriate to participate in this study as judged by the investigator.

Primary outcomes:
measure: Number of participants with DLTs
timeFrame: During the first three weeks of treatment with PM8002
measure: Treatment related adverse events (TRAEs)
timeFrame: Up to 30 days after last treatment
measure: Objective response rate (ORR)
timeFrame: Up to approximately 2 years
Secondary outcomes:
measure: Disease control rate (DCR)
timeFrame: Up to approximately 2 years
measure: Duration of response (DoR)
timeFrame: Up to approximately 2 years
measure: Overall survival (OS)
timeFrame: Up to approximately 2 years
measure: Progression-free survival (PFS)
timeFrame: Up to approximately 2 years
measure: Anti-drug antibody (ADA)
timeFrame: Up to 30 days after last treatment
Other outcomes:
Locations:
city: Baoji
country: China
facility: Baoji Central Hospital
city: Baoji
country: China
facility: Baoji Central Hospital
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences
city: Beijing
country: China
facility: Peking University Cancer Hospital
city: Beijing
country: China
facility: Peking University Cancer Hospital
city: Changchun
country: China
facility: Jilin Cancer Hospital
city: Changchun
country: China
facility: The First Hospital of Jilin University
city: Changde
country: China
facility: Changde First People's Hospital
city: Changsha
country: China
facility: Hunan Provincial People's Hospital
city: Changzhou
country: China
facility: The First People's Hospital of Changzhou
city: Chengdu
country: China
facility: Chengdu Integrated TCM& Western Medicine Hospital
city: Chengdu
country: China
facility: Sichuan Cancer Hospital
city: Chongqing
country: China
facility: Chongqing Cancer Hospital
city: Chongqing
country: China
facility: Chongqing Cancer Hospital
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
city: Chongqing
country: China
facility: The Southwest Hospital of AMU
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
city: Hefei
country: China
facility: Anhui Provincial Hospital
city: Linyi
country: China
facility: Linyi Cancer Hospital
city: Nanjing
country: China
facility: Jiangsu Province Hospital
city: Nanjing
country: China
facility: Jiangsu Province Hospital
city: Shanghai
country: China
facility: Shanghai Orient Hospital
city: Shanghai
country: China
facility: Shanghai Sixth People's Hospital
city: Shengjing
country: China
facility: Shengjing Hospital of China Medical University
city: Shenyang
country: China
facility: Liaoning Cancer Hospital
city: Shenyang
country: China
facility: The First Hospital of China Medical University
city: Shenyang
country: China
facility: The People's Hospital of Liaoning Province
city: Shijiazhuang
country: China
facility: The Fourth Hospital of Hebei Medical University
city: Taiyuan
country: China
facility: Shanxi Bethune Hospital
city: Taiyuan
country: China
facility: Shanxi Provincial Cancer Hospital
city: Taiyuan
country: China
facility: Shanxi Provincial Cancer Hospital
city: Taizhou
country: China
facility: Taizhou Hospital of Zhejiang Province
city: Tianjin
country: China
facility: The Second Hospital of Tianjin Medical University
city: Wuhan
country: China
facility: Hubei Cancer Hospital
city: Wuhan
country: China
facility: Hubei Cancer Hospital
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
city: Xi'an
country: China
facility: Xi 'an International Medical Center Hospital
city: Xi'an
country: China
facility: Xi 'an International Medical Center Hospital
city: Yantai
country: China
facility: Yantai Yuhuangding Hospital
city: Yibin
country: China
facility: Yibin Second People's Hospital
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
city: Zhengzhou
country: China
facility: The first affilated hospital of zhengzhou university
city: Zhengzhou
country: China
facility: The first affilated hospital of zhengzhou university
city: Zhujiang
country: China
facility: Zhujiang Hospital of Southern Medical University
Study officials:
affiliation: Shanghai Orient Hospital
name: Ye Guo
role: PRINCIPAL_INVESTIGATOR
References: