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| Name | Class |
|---|---|
| Parexel | INDUSTRY |
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This is a multi-center, Phase 2, open-label, single dose level study of PRL3-zumab monotherapy in patients with unresectable or metastatic solid tumor.
The study consists of a Screening Period (Day - 14 to Day -1), a Treatment Period during which visits will occur every 2 weeks, an End of Treatment visit within 14 days of the decision to discontinue treatment for any reason, and a Safety Follow-up visit at 14 ± 4 days after the last dose of study treatment. PRL3-zumab will be administered by intravenous (IV) infusion till patient meets any of the discontinuation criteria (progressive disease, clinically or per RECIST v1.1 and iRECIST, intolerable toxicity or withdrawal of consent). One cycle of treatment will be 4 weeks (2 infusions, 12 days ±2 days apart).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRL3-zumab | Experimental | All patients will receive PRL3-zumab until clinical progression per RECIST v1.1 and iRECIST criteria, or unacceptable toxicity, or withdraws consent. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRL3-zumab | Biological | Starting dose of 6 mg/kg will be administered as IV infusion over 60 minutes every 2 weeks (±2 days) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival (PFS) | PFS is defined as the time from the initiation of study treatment to the date of disease progression as per RECIST v1.1 and iRECIST criteria. | From first dose of study drug until disease progression or end of treatment, whichever comes first |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Description: ORR is defined as the percentage of patients with complete response (CR) or partial response (PR) as per RECIST v1.1 and iRECIST criteria from time of initiation of study treatment. | Time Frame: From first dose of study drug until disease progression or end of treatment, whichever comes first. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HonorHealth Research | Scottsdale | Arizona | 85258 | United States | ||
| St. Jude Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40345181 | Derived | Park DJ, Thura M, Chiu VK, Vicuna B, Ang KH, Sanchez B, Chia PL, Kuan KY, Li J, Zhang K, Zheng WH, Hsien Ng MC, Zeng Q. The PRL3-zumab paradigm: A multicenter, single-dose-level phase 2 basket clinical trial design of an unconventional cancer immunotherapy. Cell Rep Med. 2025 May 20;6(5):102120. doi: 10.1016/j.xcrm.2025.102120. Epub 2025 May 8. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| Clinical benefit rate (CBR) |
Description: CBR is defined as the percentage of patients with CR, PR, or stable disease (SD) as per RECIST v1.1 and iRECIST criteria based on Investigator's assessment. |
| Time Frame: From first dose of study drug until disease progression or end of treatment, whichever comes first |
| Overall survival (OS) | Description: OS is defined as the time from the initiation of study treatment to death from any cause. | Time Frame: From first dose of study drug until disease progression or end of treatment, whichever comes first |
| Duration of response | Description: Duration of response is defined as the time from the initial documented response (CR or PR) to the first documented sign of disease progression as per RECIST v1.1 and iRECIST criteria or death. | Time Frame: From first dose of study drug until disease progression or end of treatment, whichever comes first |
| Terminal elimination half life (t½) | To assess PK after single and multiple dose administration of PRL3-zumab. | Pre-dose and during first dose of C1, pre dose C1D15, C2D1, C2D15, C3D1, and pre dose and during the second dose of C3, pre-dose C4D1, C5D1, C6D1 and at end of treatment (up to approximately 6 months). Duration of 1 cycle is 4 weeks. C = Cycle, D = Day. |
| Maximum plasma PRL3-zumab concentration (Cmax) | To assess pharmacokinetics (PK) after single and multiple dose administration of PRL3-zumab. | Pre-dose and during first dose of C1, pre dose C1D15, C2D1, C2D15, C3D1, and pre dose and during the second dose of C3, pre-dose C4D1, C5D1, C6D1 and at end of treatment (up to approximately 6 months). Duration of 1 cycle is 4 weeks. C = Cycle, D = Day. |
| Time of Cmax (tmax) | To assess PK after single and multiple dose administration of PRL3-zumab. | Pre-dose and during first dose of C1, pre dose C1D15, C2D1, C2D15, C3D1, and pre dose and during the second dose of C3, pre-dose C4D1, C5D1, C6D1 and at end of treatment (up to approximately 6 months). Duration of 1 cycle is 4 weeks. C = Cycle, D = Day. |
| Area under the concentration time curve from pre-dose (AUCinf) | To assess PK after single and multiple dose administration of PRL3-zumab. | Pre-dose and during first dose of C1, pre dose C1D15, C2D1, C2D15, C3D1, and pre dose and during the second dose of C3, pre-dose C4D1, C5D1, C6D1 and at end of treatment (up to approximately 6 months). Duration of 1 cycle is 4 weeks. C = Cycle, D = Day. |
| Number of patients with adverse events and serious adverse events | To assess safety of PRL3-zumab in patients with unresectable or metastatic solid tumors. | From first dose of study drug until disease progression or end of treatment, whichever comes first |
| European Quality-5D (EQ-5D) | The system comprises 5 questions, 1 for each of 5 domains: mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Each is rated according to 3 response levels ("no problems," "some problems," or "extreme problems"). | From first dose of study drug until disease progression or end of treatment, whichever comes first |
| European Organization for Research and Treatment of Cancer-quality of life quantionnaire-C30 (EORTC-QLQ-C30) | Health-related quality of life is measured by EORTC-QLQ-C30, a 30 item questionnaire. This scale consists of functioning scales and symptom scales. For functioning scales higher scores suggest better functioning; for symptom scales higher scores suggest higher symptom burden. | From first dose of study drug until disease progression or end of treatment, whichever comes first |
| Fullerton |
| California |
| 92835 |
| United States |
| The Angeles Clinic | Los Angeles | California | 90025 | United States |
| Norton Healthcare | Louisville | Kentucky | 40200 | United States |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89014 | United States |