Clinical trial NCT05159700: A Phase I Study, Evaluating the Safety, Pharmacokinetics and Efficacy of PRJ1-3024 in Subjects with Advanced Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumor
Advanced Solid Malignancies
Keywords: First in human
Maximum tolerated dose
Recommended Phase 2 dose
Dose Escalation
Hematopoietic progenitor kinase 1
PRJ1-3024
Lead sponsor: Zhuhai Yufan Biotechnologies Co., Ltd
Sponsor class: INDUSTRY
First posted: 2021-12-16
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Incidence of dose-limiting toxicity (DLT) events during the DLT monitoring period
timeFrame: Day 1 to Day 21
Secondary outcomes:
measure: Incidence of adverse events (AEs)
timeFrame: 24 months
measure: Pharmacokinetic parameter： Accumulation ratio
timeFrame: 24 months
measure: Objective response rate (ORR)
timeFrame: 24 months
measure: Duration of response (DOR)
timeFrame: 24 months
measure: Pharmacokinetic parameter：AUC（0-last）
timeFrame: 24 months
measure: Pharmacokinetic parameter：Maximum observed concentration (Cmax)
timeFrame: 24 months
Other outcomes:
Locations:
city: Denver
country: United States
facility: Sarah Cannon Research Institute at HealthONE
state: Colorado
city: Orlando
country: United States
facility: Sarah Cannon Research Institute at Florida Cancer Specialists
state: Florida
city: Cincinnati
country: United States
facility: Christ Hospital
state: Ohio
city: Austin
country: United States
facility: NEXT Oncology
state: Texas
city: San Antonio
country: United States
facility: Mays Cancer Center
state: Texas
city: Fairfax
country: United States
facility: NEXT Oncology
state: Virginia
Study officials:
affiliation: Head of US Clinical Development
name: Yang Xu, PhD
role: STUDY_DIRECTOR
References: