Advanced Solid Tumors
Conditions
Keywords
PD-L1, 4-1BB
Brief summary
This is a single-arm, open-lable, multicenter phase I/IIa clinical trial evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of PM1003 in the treatment of advanced solid tumors.
Detailed description
PM1003 is a Bispecific Antibody Targeting PD-L1 and 4-1BB.
Interventions
BIOLOGICALPM1003 Injection
Subjects will receive PM1003 by intravenous administration.
Sponsors
Biotheus Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
In dose escalation stage, three subjects will be enrolled at the protocol starting dose of PM1032 for 21 Days DLT observation, followed by same dose every 2 weeks (Q2W) until they meet the discontinuation criteria. Dose escalation will proceed to the next dose level according to the 3+3 design. Dose expansion stage of the study will be initiated at the Sponsor's discretion at the dose level and treatment schedule which was established as the recommended Phase 2 dose (RP2D) in the dose escalation stage.
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. Subjects with malignant tumor confirmed by histology or cytology; 4. Adequate organ function; 5. ECOG score was 0-1. 6. Pre-menopausal female subjects with negative blood pregnancy results within 7 days prior to the study treatment, and agree to abstain from sex or use medically approved effective contraceptive measures for 6 months from the date of signing the informed consent form to the end of the last medication; 7. Male subjects are agree to abstain from sex or use medically approved effective contraceptive methods for 6 months from the date of signing the informed consent form to the end of the last medication, and do not donate sperm during this period.
Exclusion criteria
1. History of severe allergic to macromolecular protein drugs, severe allergy to drugs or known allergy to any component of the drug in this study; 2. Treatment with any 4-1BB monoclonal antibody or 4-1BB-containing dual antibody immune co-stimulatory molecule agonist; 3. Current active infection requiring intravenous anti-infective therapy; 4. Current presence of uncontrolled pleural, pericardial, and peritoneal effusions; 5. Known history of alcohol abuse, psychotropic drug abuse or drug abuse; 6. History of neurological or psychiatric disorders, such as epilepsy, dementia, schizophrenia, etc.; 7. Anticipated need for any other form of antineoplastic drug treatment during the trial; 8. Women who are pregnant or breastfeeding; 9. Other conditions lead to inappropriate to participate in this study as judged by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose Limited Toxicity（DLT） | up to 21 days | Occurrence of DLT after receiving PM1003 injection |
| Assess the incidence and severity of treatment-related adverse events | Up to 30 days after last treatment | The incidence and severity of treatment-emergent adverse events (TEAEs) and treatment related adverse events (TRAEs) graded according to NCI-CTCAE v5.0 |
Countries
China
Contacts
Primary ContactJie Zhang
Backup ContactYe Guo
Outcome results
None listed