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| ID | Type | Description | Link |
|---|---|---|---|
| CXHL2101725 | Other Identifier | CDE |
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This is a multicenter, open-label study to assess the safety and preliminary efficacy and to determine the maximum tolerated dose (MTD) or maximum administration dose (MAD) and recommended Phase 2 doses (RP2D) of PRJ1-3024 in subjects with relapsed/refractory solid tumors. The study consists of two parts, one is a 3+3 dose escalation study and another is a pharmaceutical extension of RP2D.
Using dose escalation, 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.
Participants with advanced solid tumor will receive PRJ1-3024 daily as an oral therapy and test the impact of of PRJ1-3024 on tumors.
This study will find the safe and tolerable recommended dose in subjects with advanced solid tumors in a open-label, 3+3 dose escalation study and use the RP2D to assess the preliminary efficacy of PRJ1-3024 in a long-term extension 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. |
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| Monotherapy Exploration of the recommended dose | Experimental | Upon completing Phase 1 and depending on data obtained, dose expansion may proceed in Phase 2 with several cohorts enrolled to confirm the tolerability of the RP2D of PRJ1-3024 (determined in Phase 1). PRJ1-3024 is administered orally once daily. The starting dose is determined by clinical effecacy data from Phase 1, and treatment may continue for up to 2 years as long as the subject experiences clinical benefit in the opinion of the Investigator and shows no signs or symptoms of unequivocal progression of disease. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRJ1-3024 | Drug | PRJ1-3024 is provided as capsules and is administered orally once a day. |
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| 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 | Role | Phone | Extension | |
|---|---|---|---|---|
| Liting Lai | Contact | 8617728075858 | vivi.lai@ming-med.com |
| Name | Affiliation | Role |
|---|---|---|
| Hui ouyang, Dr. | VP | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first affiliated hospital of Zhengzhou University | Recruiting | Zhengzhou | Henan | China |
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Part 1 is a Phase 1, open label, 3+3 dose escalation study to determine the safety and preliminary efficacy of PRJ1-3024. Upon completing Phase 1 and depending on data obtained, dose expansion may proceed in Phase 2 to confirm the tolerability and efficacy of the RP2D 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#AUC0-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 |
| West China Hospital of Sichuan University | Recruiting | Chengdu | Sichuan | China |
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| Cancer hospital of the University of Chinese Academy of Sciences | Recruiting | Hangzhou | Zhejiang | China |
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| Beijing Cancer Hospital | Recruiting | Beijing | 100142 | China |
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| The Fifth Medical Center of PLA General Hospital | Recruiting | Beijing | China |
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| 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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