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This is a Phase I, multicenter, open-label, 3+3 dose escalation study to determine the safety and preliminary efficacy of PRJ1-3024 in subjects with relapsed/refractory solid tumors.
The study will evaluate the safety, tolerability, PK, and pharmacodynamics of PRJ1-3024 and will determine the maximum tolerated dose in subjects with advanced solid tumors.
PRJ1-3024 will be evaluated as an oral therapeutic that tests the anti-tumor activity of PRJ1-3024 in patients with solid tumors and has not yet been tested in humans.
This study will find the safe and tolerable recommended dose in subjects with advanced solid tumors as a open-label, 3+3 dose escalation study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monotherapy Escalation | Experimental | 3+3 Dose escalation arm with PRJ1-3024 which will begin with 2 subjects treated at the lowest planned dose level PRJ1-3024 is administered orally once daily. The starting dose is 80mg/day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRJ1-3024 | Drug | PRJ1-3024 is provided as capsules and is administered orally once a day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of dose-limiting toxicity (DLT) events during the DLT monitoring period | Safety listings and pharmacokinetic listings will be used for evaluation | Day 1 to Day 21 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) | Characterized by type, seriousness, relationship to study treatment, timing, and severity. | 24 months |
| Pharmacokinetic parameter: Accumulation ratio | to estimate the accumulation of PRJ1-3024 from time 0 to the time of last quantifiable concentration after multiple administration |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yang Xu, PhD | Head of US Clinical Development | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sarah Cannon Research Institute at HealthONE | Denver | Colorado | 80218 | United States | ||
| Sarah Cannon Research Institute at Florida Cancer Specialists |
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This is a Phase 1, open label, 3+3 dose escalation study to determine the safety and preliminary efficacy of PRJ1-3024.
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| 24 months |
| Objective response rate (ORR) | estimated by the proportion of subjects having a complete response (CR) or partial response (PR) with use of RECIST v1.1 criteria. | 24 months |
| Duration of response (DOR) | defined as time from the first occurrence of a documented objective response to the time of relapse or death from any cause. | 24 months |
| Pharmacokinetic parameter:AUC(0-last) | Area under the concentration-time curve AUC from time 0 to the time of the last quantifiable concentration | 24 months |
| Pharmacokinetic parameter:Maximum observed concentration (Cmax) | assessed as time from time 0 to the time of the last quantifiable concentration | 24 months |
| Orlando |
| Florida |
| 32827 |
| United States |
| Christ Hospital | Cincinnati | Ohio | 21073 | United States |
| NEXT Oncology | Austin | Texas | 73301 | United States |
| Mays Cancer Center | San Antonio | Texas | 78229 | United States |
| NEXT Oncology | Fairfax | Virginia | 22031 | United States |
| ID | Term |
|---|---|
| D009477 | Hereditary Sensory and Autonomic Neuropathies |
| ID | Term |
|---|---|
| D009421 | Nervous System Malformations |
| D009422 | Nervous System Diseases |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D011115 | Polyneuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D030342 | Genetic Diseases, Inborn |
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