Malignant Neoplasm
Conditions
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.
Interventions
DRUGPM8002
IV infusion
Sponsors
Biotheus Inc.
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with DLTs | 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) | Up to 30 days after last treatment | The incidence and severity of TRAEs graded according to NCI-CTCAE v5.0 |
| Objective response rate (ORR) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) | Up to approximately 2 years | 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. |
| Disease control rate (DCR) | Up to approximately 2 years | DCR is defined as the proportion of subjects with CR, PR, or stable disease(SD) based on RECIST v1.1. |
| Anti-drug antibody (ADA) | Up to 30 days after last treatment | To evaluate the incidence of ADA to PM8002. |
| Duration of response (DoR) | Up to approximately 2 years | 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. |
| Overall survival (OS) | Up to approximately 2 years | OS is the time from the date of first dosing date to death due to any cause. |
Countries
China
Contacts
Primary ContactYe Guo
Outcome results
None listed