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The goal of this clinical trial is to evaluate the safety and tolerability of escalating doses of PTX-912 in patients with locally advanced or metastatic solid tumors. To evaluate the PK and immunogenicity profile of PTX-912. To evaluate the preliminary anti-tumor activity of PTX-912.
Participants will be treated with PTX-912 via iv infusion, every 2 weeks until progression of disease, unacceptable toxicity, or 12 months of total study therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PTX-912 | Experimental | Single or multiple ascending dose of PTX-912 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PTX-912 | Drug | Investigation Product Monotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| DLTs (dose limiting toxicity) | Frequency, severity, and duration of treatment-emergent adverse events (TEAEs) and laboratory abnormalities for all dose groups according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0; except for cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) which will be graded according to American Society for Transplantation and Cellular Therapy (ASTCT) Consensus Grading. | within 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Project Manager | Contact | 425-233-1480 | ze.zhang@provivatx.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope National Medical Center | Recruiting | Duarte | California | 91010 | United States |
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| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| University of Miami | Recruiting | Miami | Florida | 33136 | United States |
|
| Nebraska Cancer Specialists (NCS) | Recruiting | Omaha | Nebraska | 68130 | United States |
|