Melanoma
Conditions
Keywords
HPK-1 inhibitor;melanoma;PRJ1-3024;Recommended Phase 2 dose
Brief summary
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
Detailed description
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.
Interventions
DRUGPRJ1-3024
PRJ1-3024 is provided as capsules and is administered orally once a day
Sponsors
Zhuhai Yufan Biotechnologies Co., Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Histologically or cytologically confirmed locally advanced (unresectable) or metastatic melanoma (with the exception of ocular uveal melanoma). Patients who have progressed or relapsed after at least 1st-line systemic standard therapy. * Male or non-pregnant, non-lactating female subjects aged ≥18 years. * ECOG Performance Status 0\ 1. * Has at least 1 measurable lesion as defined by RECIST 1.1 criteria. * Life expectancy of ≥3 months, in the opinion of the Investigator. * Able to take oral medications and willing to record daily adherence to investigational product. * Adequate hematologic parameters. * Adequate renal and hepatic function * Able to understand and willing to sign a written informed consent form. * Consent to provide archived tissue specimen or tissue sample.
Exclusion criteria
• History of another malignancy. * Known symptomatic brain metastases requiring \>10 mg/day of prednisolone. * Significant cardiovascular disease. * Known active HBV, HCV, AIDS-related illness. * Has received a live vaccine within 30 days. * History of active autoimmune disorders, or ongoing immunosuppressive therapy. * Continuance of toxicities due to prior radiotherapy or chemotherapy agents that do not recover to \< Grade 2. * Receiving concurrent anti-cancer therapy, investigational product, strong inhibitors or inducers of cytochrome P450 3A (CYP3A) . * Prior treatment with other hematopoietic progenitor kinase 1 (HPK1) inhibitors. * Allergy to the ingredients of study drug, or a history of other allergies which were judged by the investigator to be unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | 24 months | Estimated by the proportion of subjects having a complete response (CR) or partial response (PR) with use of RECIST v1.1 criteria. |
| Recommended phase 2 dose (RP2D) | 24 months | To determine the RP2D in China advanced metastatic melanoma patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease control rate (DCR) | 24 months | To access the response of patients, particularly whether the treatment is able to shrink or stabilize the tumor. |
| Pharmacokinetic parameters (PK) | 24 months | Peak Plasma Concertration(Cmax) |
| Duration of response (DOR) | 24 months | Defined as time from the first occurrence of a documented objective response to the time of relapse or death from and cause. |
| Pharmacokinetic parameters(PK) | 24 months | Area under the plasma concentration versus time curve (AUC) |
| Incidence of adverse events (AEs) | 24 months | Characterized by type, seriousness, relationship to study treatment, timing, and severity |
| Progression-Free Survival (PFS) | 24 months | Calculated from the start of treatment until the first occurrence of disease progression or death, whichever comes first. |
Countries
China
Contacts
Primary ContactLiting Lai, Bachelor
Outcome results
None listed