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

Last updated: January 1, 2025
Sponsor: Zhuhai Yufan Biotechnologies Co., Ltd
Overall Status: Completed

Phase

1

Condition

Neoplasms

Treatment

PRJ1-3024

Clinical Study ID

NCT05159700
PRJ1-3024 CS101
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Histologically or cytologically confirmed locally advanced (unresectable) ormetastatic r/r solid tumors for which no standard therapy is available or for whomstandard 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 toinvestigational 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

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 inhibitorsor inducers of cytochrome P450 3A (CYP3A) .

  • Prior treatment with hematopoietic progenitor kinase 1 (HPK1) inhibitors.

Study Design

Total Participants: 39
Treatment Group(s): 1
Primary Treatment: PRJ1-3024
Phase: 1
Study Start date:
March 31, 2022
Estimated Completion Date:
October 12, 2024

Study 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.

Connect with a study center

  • Sarah Cannon Research Institute at HealthONE

    Denver, Colorado 80218
    United States

    Site Not Available

  • Sarah Cannon Research Institute at Florida Cancer Specialists

    Orlando, Florida 32827
    United States

    Site Not Available

  • Christ Hospital

    Cincinnati, Ohio 21073
    United States

    Site Not Available

  • NEXT Oncology

    Austin, Texas 73301
    United States

    Site Not Available

  • Mays Cancer Center

    San Antonio, Texas 78229
    United States

    Site Not Available

  • NEXT Oncology

    San Antonio, Texas 78229
    United States

    Site Not Available

  • NEXT Oncology

    Fairfax, Virginia 22031
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.