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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Advanced Solid Tumor; Advanced Solid Malignancies
• Intervention / Treatment: Drug: PRJ1-3024

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 Type: Interventional
• Enrollment (Actual): 39
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80218
      • Sarah Cannon Research Institute at HealthONE
  • Florida
    • Orlando, Florida, United States, 32827
      • Sarah Cannon Research Institute at Florida Cancer Specialists
  • Ohio
    • Cincinnati, Ohio, United States, 21073
      • Christ Hospital
  • Texas
    • Austin, Texas, United States, 73301
      • Next Oncology
    • San Antonio, Texas, United States, 78229
      • Mays Cancer Center
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Next Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Monotherapy Escalation; 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.	Drug: PRJ1-3024; PRJ1-3024 is provided as capsules and is administered orally once a day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events (AEs)	Characterized by type, seriousness, relationship to study treatment, timing, and severity.	24 months
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
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
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
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
Pharmacokinetic parameter：Maximum observed concentration (Cmax)	assessed as time from time 0 to the time of the last quantifiable concentration	24 months

Collaborators and Investigators

• Sponsor: Zhuhai Yufan Biotechnologies Co., Ltd
• Investigators: Study Director: Yang Xu, PhD, Head of US Clinical Development

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2022
• Primary Completion (Actual): July 17, 2024
• Study Completion (Estimated): June 29, 2026

Study Registration Dates

• First Submitted: December 7, 2021
• First Submitted That Met QC Criteria: December 15, 2021
• First Posted (Actual): December 16, 2021

Study Record Updates

• Last Update Posted (Estimated): December 15, 2025
• Last Update Submitted That Met QC Criteria: December 5, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Maximum tolerated dose; Dose Escalation; Recommended Phase 2 dose; First in human; Hematopoietic progenitor kinase 1; PRJ1-3024
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Peripheral Nervous System Diseases; Neurodegenerative Diseases; Congenital Abnormalities; Heredodegenerative Disorders, Nervous System; Nervous System Malformations; Polyneuropathies; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hereditary Sensory and Autonomic Neuropathies
• Other Study ID Numbers: PRJ1-3024 CS101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No