A Phase I Study, Evaluating the Safety, Pharmacokinetics and Efficacy of PRJ1-3024 in Subjects with Advanced Solid Tumors

Phase 1

Completed

• Conditions: Advanced Solid Tumor; Advanced Solid Malignancies
• Interventions: Drug: PRJ1-3024

• Registration Number: NCT05159700
• Lead Sponsor: Zhuhai Yufan Biotechnologies Co., Ltd

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.

Study Timeline

• Study First Submitted: 2021-12-07
• Study First Submitted QC: 2021-12-15
• Study First Posted: 2021-12-16
• Study Start: 2022-03-31
• Primary Completion: 2024-07-17
• Study Completion: 2024-10-12
• Status Verified: 2024-12
• Last Update Submitted: 2025-01-01
• Last Update Posted: 2025-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Monotherapy Escalation	PRJ1-3024	3+3 Dose escalation arm with PRJ1-3024 which will begin with 2 subjects treated at the lowest planned dose level PRJ1-3024 is administered orally once daily. The starting dose is 80mg/day.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Incidence of adverse events (AEs)	24 months	Characterized by type, seriousness, relationship to study treatment, timing, and severity.
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.
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： 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.

Trial Locations

Locations (5)

Sarah Cannon Research Institute at HealthONE; 🇺🇸 Denver, Colorado, United States

Sarah Cannon Research Institute at Florida Cancer Specialists; 🇺🇸 Orlando, Florida, United States

Christ Hospital; 🇺🇸 Cincinnati, Ohio, United States

NEXT Oncology; 🇺🇸 Fairfax, Virginia, United States

Mays Cancer Center; 🇺🇸 San Antonio, Texas, United States