Advanced Solid Tumor Clinical Trial
Official title:
A Phase I, First-In-Human, Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of PRJ1-3024 in Subjects With Advanced Solid Tumors
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.
Status | Recruiting |
Enrollment | 46 |
Est. completion date | August 15, 2024 |
Est. primary completion date | February 15, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | NEXT Oncology | Austin | Texas |
United States | Christ Hospital | Cincinnati | Ohio |
United States | Sarah Cannon Research Institute at HealthONE | Denver | Colorado |
United States | NEXT Oncology | Fairfax | Virginia |
United States | Sarah Cannon Research Institute at Florida Cancer Specialists | Orlando | Florida |
United States | Mays Cancer Center | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
Zhuhai Yufan Biotechnologies Co., Ltd |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | Incidence of adverse events (AEs) | Characterized by type, seriousness, relationship to study treatment, timing, and severity. | 24 months | |
Secondary | Pharmacokinetic parameter: Accumulation ratio | to estimate the accumulation of PRJ1-3024 from time 0 to the time of last quantifiable concentration after multiple administration | 24 months | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Pharmacokinetic parameter:AUC(0-last) | Area under the concentration-time curve AUC from time 0 to the time of the last quantifiable concentration | 24 months | |
Secondary | Pharmacokinetic parameter:Maximum observed concentration (Cmax) | assessed as time from time 0 to the time of the last quantifiable concentration | 24 months |
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