Brain Neoplasms, Lung Neoplasms, Other Protocol Specified Criteria, Protein Kinase Inhibitors
Conditions
Keywords
ROS1 Fusions, ROS1 Gene Rearrangements, Primary brain tumors, ROS1
Brief summary
An open, non-randomized, multicenter, single-arm dose-escalation design, phase 1 trial to study the safety, tolerability, pharmacokinetics and efficacy of JYP0322 in patients with ROS1+ locally advanced/metastatic solid tumors .
Detailed description
JYP0322 is an orally available inhibitor of ROS1 (coded by the gene ROS1). Molecular fusions are present in several different tumor types, including non-small cell lung cancer (NSCLC), glioma, etc. Patients with locally advanced or metastatic cancer with a detectable molecular fusion in targets of interest may be eligible for enrollment. Phase 1 will assess safety and tolerability of JYP0322 via standard dose escalation scheme and determine the recommended Phase 2 dose. Safety and efficacy will be assessed in the dose expansion portion of the study.
Interventions
DRUGJYP0322 50 mg qd
JYP0322 is administered orally at a dose of 50 mg qd for a specified duration until unacceptable toxicity, disease progression, or study completion.
DRUGJYP0322 100 mg qd
JYP0322 is administered orally at a dose of 100 mg qd for a specified duration until unacceptable toxicity, disease progression, or study completion.
DRUGJYP0322 200 mg qd
JYP0322 is administered orally at a dose of 200 mg qd for a specified duration until unacceptable toxicity, disease progression, or study completion.
DRUGJYP0322 100 mg bid
JYP0322 is administered orally at a dose of 100 mg bid for a specified duration until unacceptable toxicity, disease progression, or study completion.
DRUGJYP0322 150 mg bid
JYP0322 is administered orally at a dose of 150 mg bid for a specified duration until unacceptable toxicity, disease progression, or study completion.
DRUGJYP0322 200 mg bid
JYP0322 is administered orally at a dose of 200 mg bid for a specified duration until unacceptable toxicity, disease progression, or study completion.
DRUGJYP0322 150mg tid
JYP0322 is administered orally at a dose of 150 mg tid for a specified duration until unacceptable toxicity, disease progression, or study completion.
Sponsors
Guangzhou JOYO Pharma Co., Ltd
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria * Adult patients age 18 years or older. * Histologically or cytologically confirmed diagnosis of locally advanced or metastatic solid tumors that have a ROS1 molecular fusion. * Measurable disease according to RECIST version 1.1 * Life expectancy of at least 3 months * Other protocol specified criteria Key
Exclusion criteria
* Current participation in another therapeutic clinical trial. * Gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would impact on drug absorption. * A history of severe allergies, or a history of severe allergy, hypersensitivity or other hypersensitivity to any active or inactive ingredient of the study drug. * Known active infections (bacterial, viral including HIV positivity). * Other protocol specified criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The frequency and severity of adverse events of JYP0322 | From the date of informed consent through 30 days after the last dose of study drug, approximately up to 36 months. | Evaluate the safety and tolerability of JYP0322 treatment. This will be assessed by: Incidence, nature, and severity of adverse events (AEs) during treatment, the proportion of patients requiring dose adjustment or permanent drug discontinuation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | From the first dose of study drug until disease progression, assessed by imaging every 8 weeks for the first 52 weeks, and every 12 weeks thereafter, up to 36 months. | ORR is the proportion of subjects with CR or PR , based on RECIST v1.1 criteria. |
| Disease Control Rate (DCR) | From the first dose of study drug until disease progression, assessed by imaging every 8 weeks for the first 52 weeks, and every 12 weeks thereafter, up to 36 months. | DCR is the proportion of subjects with CR or PR or SD, based on RECIST v1.1 criteria. |
| Duration of Response (DOR) | From the date of first response until disease progression or death, assessed by imaging every 8 weeks for the first 52 weeks, and every 12 weeks thereafter, up to 36 months. | The time from the first documented objective response to the first occurrence of tumor progression or death from any cause. |
| Time to Response (TTR) | From the first dose of study drug to the date of first objective response, assessed by imaging every 8 weeks for the first 52 weeks, and every 12 weeks thereafter, up to 36 months. | The time from treatment initiation to the first documented objective response. |
| Progression-Free Survival (PFS) | From the first dose of study drug until disease progression or death, assessed by imaging every 8 weeks for the first 52 weeks, and every 12 weeks thereafter, up to 36 months. | The time from initiation of JYP0322 treatment to tumor progression or death from any cause. |
Countries
China
Outcome results
None listed