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Recruiting Phase 1/2

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

NCT05315167 · tracked via the Priya Life Science China tracker
Sponsor
Zhuhai Yufan Biotechnologies Co., Ltd
Phase
Phase 1/2
Started
2022-05-30
Last updated
2024-12-17

Condition(s) studied

Advanced Solid TumorAdvanced Solid Malignancies

Investigational drug(s) / intervention(s)

PRJ1-3024 →

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

Study summary

This is a multicenter, open-label study to assess the safety and preliminary efficacy and to determine the maximum tolerated dose (MTD) or maximum administration dose (MAD) and recommended Phase 2 doses (RP2D) of PRJ1-3024 in subjects with relapsed/refractory solid tumors. The study consists of two parts, one is a 3+3 dose escalation study and another is a pharmaceutical extension of RP2D.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
\- 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\~1. * 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 or ongoing . * Continuance of toxicities due to prior radiotherapy or chemotherapy agents that do not recover to \< Grade 2. * 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 outcome measure(s)

  • 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

Trial sites (5)

FacilityCityRegionStatus
The first affiliated hospital of Zhengzhou University Zhengzhou Henan Recruiting
West China Hospital of Sichuan University Chengdu Sichuan Recruiting
Cancer hospital of the University of Chinese Academy of Sciences Hangzhou Zhejiang Recruiting
Beijing Cancer Hospital Beijing China Recruiting
The Fifth Medical Center of PLA General Hospital Beijing China Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05315167 on ClinicalTrials.gov ↗ ← All trials in China