Advanced Solid Malignancies, Advanced Solid Tumor
Conditions
Keywords
First in human, Maximum tolerated dose, Recommended Phase 2 dose, Dose Escalation, Hematopoietic progenitor kinase 1, PRJ1-3024
Brief summary
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.
Detailed description
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.
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
Intervention model description
This is a Phase 1, open label, 3+3 dose escalation study to determine the safety and preliminary efficacy of PRJ1-3024.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Histologically or cytologically confirmed locally advanced (unresectable) or metastatic r/r solid tumors for which no standard therapy is available or for whom standard therapy is considered unsuitable or intolerable. * Male or non-pregnant, non-lactating female subjects age ≥18 years. * ECOG Performance Status 0\ 2. * 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 unless clearly due to the disease under study. * Adequate renal and hepatic function * Able to understand and willing to sign a written informed consent form. Key
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. * Receiving concurrent anti-cancer therapy, investigational product, strong inhibitors or inducers of cytochrome P450 3A (CYP3A) . * Prior treatment with hematopoietic progenitor kinase 1 (HPK1) inhibitors.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of dose-limiting toxicity (DLT) events during the DLT monitoring period | Day 1 to Day 21 | Safety listings and pharmacokinetic listings will be used for evaluation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic parameter： Accumulation ratio | 24 months | to estimate the accumulation of PRJ1-3024 from time 0 to the time of last quantifiable concentration after multiple administration |
| 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. |
| Incidence of adverse events (AEs) | 24 months | Characterized by type, seriousness, relationship to study treatment, timing, and severity. |
| Pharmacokinetic parameter：AUC（0-last） | 24 months | Area under the concentration-time curve AUC from time 0 to the time of the last quantifiable concentration |
| Pharmacokinetic parameter：Maximum observed concentration (Cmax) | 24 months | assessed as time from time 0 to the time of the last quantifiable concentration |
| 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 any cause. |
Countries
United States
Outcome results
None listed