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Trial Title:
PM8002 in the Treatment of Patients With Advanced Solid Tumors
NCT ID:
NCT05918445
Condition:
Malignant Neoplasm
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
PM8002
Description:
IV infusion
Arm group label:
PM8002
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai Orient Hospital
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
YE GUO
Phone:
135 0167 8472
Email:
pattrickguo@gmail.com
Start date:
March 9, 2021
Completion date:
November 30, 2024
Lead sponsor:
Agency:
Biotheus Inc.
Agency class:
Industry
Source:
Biotheus Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05918445
