Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
PM1003 is a Bispecific Antibody Targeting PD-L1 and 4-1BB.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PM1003 | Experimental | PM1003 0.02mg/kg-10mg/kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PM1003 Injection | Biological | Subjects will receive PM1003 by intravenous administration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose Limited Toxicity(DLT) | Occurrence of DLT after receiving PM1003 injection | up to 21 days |
| Assess the incidence and severity of treatment-related adverse events | The incidence and severity of treatment-emergent adverse events (TEAEs) and treatment related adverse events (TRAEs) graded according to NCI-CTCAE v5.0 | Up to 30 days after last treatment |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jie Zhang | Contact | +86 18221509791 | zhang.jie@biotheus.com | |
| Ye Guo | Contact | pattrickguo@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ye Guo | Shanghai Orient Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital Affiliated to Shandong First Medical University | Recruiting | Jinan | Shandong | China |
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Shanghai Orient Hospital | Recruiting | Shanghai | China |
|