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

NCT05315167 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 267

Last updated 2024-12-17

No results posted yet for this 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.

Conditions

  • Advanced Solid Tumor
  • Advanced Solid Malignancies

Interventions

DRUG

PRJ1-3024

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

Sponsors & Collaborators

  • Zhuhai Yufan Biotechnologies Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Hui ouyang, Dr. · VP

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-30
Primary Completion
2027-05-15
Completion
2027-11-15

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05315167 on ClinicalTrials.gov