This is a Phase Ib, open-label study to determine the safety and preliminary efficacy of PRJ1-3024 in China subjects with unresectable local advanced or metastatic melanoma
The study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PRJ1-3024 and will determine the recommended dose in China subjects with unresectable local advanced or metastatic melanoma. PRJ1-3024 is a small molecular Hematopoietic progenitor kinase (HPK-1) inhibitor. It will be evaluated as an oral therapeutic that tests the anti-tumor activity in patients with unresectable or metastatic melanoma and has not yet been tested in humans.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
PRJ1-3024 is provided as capsules and is administered orally once a day
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGObjective 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.
Time frame: 24 months
Recommended phase 2 dose (RP2D)
To determine the RP2D in China advanced metastatic melanoma patients
Time frame: 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 and cause.
Time frame: 24 months
Progression-Free Survival (PFS)
Calculated from the start of treatment until the first occurrence of disease progression or death, whichever comes first.
Time frame: 24 months
Disease control rate (DCR)
To access the response of patients, particularly whether the treatment is able to shrink or stabilize the tumor.
Time frame: 24 months
Pharmacokinetic parameters (PK)
Peak Plasma Concertration(Cmax)
Time frame: 24 months
Incidence of adverse events (AEs)
Characterized by type, seriousness, relationship to study treatment, timing, and severity
Time frame: 24 months
Pharmacokinetic parameters (PK)
Minimum Concertration
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 24 months
Pharmacokinetic parameters (PK)
Time to peak drug concentration(Tmax)
Time frame: 24 months
Pharmacokinetic parameters(PK)
Area under the plasma concentration versus time curve (AUC)
Time frame: 24 months