Menu
Recruiting NCT05315167

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

Phase I / Phase II Interventional Advanced Solid Tumor Advanced Solid Malignancies

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PRJ1-3024.
Who it may be relevant to
Registry conditions: Advanced Solid Tumor, Advanced Solid Malignancies. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 1/2, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Prime Efficacy of PRJ1-3024 in Subjects with Advanced Solid Tumors

Overview

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.

Detailed description

Using dose escalation, 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.

Participants with advanced solid tumor will receive PRJ1-3024 daily as an oral therapy and test the impact of of PRJ1-3024 on tumors.

This study will find the safe and tolerable recommended dose in subjects with advanced solid tumors in a open-label, 3+3 dose escalation study and use the RP2D to assess the preliminary efficacy of PRJ1-3024 in a long-term extension study.

Interventions

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

Primary outcome measures

  • Incidence of dose-limiting toxicity (DLT) events during the DLT monitoring period [Time frame: Day 1 to Day 21]
Secondary outcome measures (6)
  • Incidence of adverse events (AEs) [Time frame: 24 months]
  • Pharmacokinetic parameter# Accumulation ratio [Time frame: 24 months]
  • Objective response rate (ORR) [Time frame: 24 months]
  • Duration of response (DOR) [Time frame: 24 months]
  • Pharmacokinetic parameter#AUC0-last# [Time frame: 24 months]
  • Pharmacokinetic parameter#Maximum observed concentration (Cmax) [Time frame: 24 months]

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\~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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

China · 5 centers
  • The first affiliated hospital of Zhengzhou University — Zhengzhou
  • West China Hospital of Sichuan University — Chengdu
  • Cancer hospital of the University of Chinese Academy of Sciences — Hangzhou
  • Beijing Cancer Hospital — Beijing
  • The Fifth Medical Center of PLA General Hospital — Beijing

Identifiers

NCT: NCT05315167 · PRJ1-3024-001 · CXHL2101725

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗