Summary

Eligibility
for people ages 12-100 (full criteria)
Location
at UCSF
Dates
study started
completion around
Principal Investigator
by Rahul Aggarwal (ucsf)
Headshot of Rahul Aggarwal
Rahul Aggarwal

Description

Summary

The primary objective of this study is to identify a safe and tolerated dose and schedule of the orally administered PLK4 inhibitor RP-1664. In addition, this study will examine the pharmacokinetics (PK), pharmacodynamics (PD) and preliminary anti-tumor activity of RP-1664 in advanced solid tumors.

Official Title

Phase 1 Trial of the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Clinical Activity of RP-1664 in Participants With Advanced Solid Tumors

Details

This is a first-in-human, Phase 1, multi-center, open-label, dose-escalation and expansion study to:

Evaluate the safety profile and MTD of RP-1664 and establish a recommended dose and schedule for further clinical investigation, In addition, the study aims to characterize the PK, PD, and preliminary anti-tumor activity of orally administered RP-1664. Exploratory objectives include examination of biomarker responses in relationship to RP-1664 exposure.

After the recommended dose and schedule is determined, expansion cohorts with molecularly selected advanced solid tumors will be enrolled to preliminarily assess the anti-tumor effect, and further examine the safety and PK of RP-1664 at the RP2D.

Keywords

Advanced Solid Tumor, Neoplasms

Eligibility

Locations

  • Participating Site 1025 accepting new patients
    San Francisco California 94143 United States
  • Participating Site 1004 accepting new patients
    New York New York 10065 United States
  • Participating Site 1008 accepting new patients
    New York New York 10032 United States

Lead Scientist at University of California Health

  • Rahul Aggarwal (ucsf)
    I am a Medical Oncologist within the Division of Hematology/Oncology at the University of California San Francisco. My clinical practice focuses on patients with advanced solid tumor malignancies with a particular emphasis on genitourinary malignancies including prostate, kidney, bladder, and testicular cancer.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Repare Therapeutics
ID
NCT06232408
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 80 study participants
Last Updated