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

NCT05159700 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: PRJ1-3024 CS101
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 6

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Incidence of adverse events (AEs)

  24 months

• Pharmacokinetic parameter： Accumulation ratio

  24 months

• Objective response rate (ORR)

  24 months

• Duration of response (DOR)

  24 months

• Pharmacokinetic parameter：AUC（0-last）

  24 months

Study Arms (1)

Monotherapy Escalation

EXPERIMENTAL

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

Interventions

PRJ1-3024 DRUG

PRJ1-3024 is provided as capsules and is administered orally once a day.

Monotherapy Escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhuhai Yufan Biotechnologies Co., Ltd: lead

Study Sites (6)

Sarah Cannon Research Institute at HealthONE

Denver, Colorado, 80218, United States

Location

Sarah Cannon Research Institute at Florida Cancer Specialists

Orlando, Florida, 32827, United States

Location

Christ Hospital

Cincinnati, Ohio, 21073, United States

Location

NEXT Oncology

Austin, Texas, 73301, United States

Location

Mays Cancer Center

San Antonio, Texas, 78229, United States

Location

NEXT Oncology

Fairfax, Virginia, 22031, United States

Location

MeSH Terms

Conditions

Hereditary Sensory and Autonomic Neuropathies

Condition Hierarchy (Ancestors)

Nervous System Malformations; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Study Officials

• Yang Xu, PhD

  Head of US Clinical Development

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a Phase 1, open label, 3+3 dose escalation study to determine the safety and preliminary efficacy of PRJ1-3024.

Study Record Dates

• First Submitted: December 7, 2021
• First Posted: December 16, 2021
• Study Start: March 31, 2022
• Primary Completion: July 17, 2024
• Study Completion (Estimated): June 29, 2026
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)