Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around
Principal Investigator
by Rahul Aggarwal
Headshot of Rahul Aggarwal
Rahul Aggarwal

Description

Summary

This is a multicenter, open-label Phase 1 trial to investigate the safety, PK, and pharmacodynamics of the Polθ inhibitor RP-3467 alone or in combination with the poly-ADP ribose polymerase inhibitor (PARPi) olaparib in adults with molecularly selected advanced solid tumors.

Official Title

Phase 1 Trial of the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Clinical Activity of RP-3467 Alone and in Combination with Olaparib in Participants with Advanced Solid Tumors (POLAR Trial)

Details

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

  • Evaluate the safety profile of RP-3467 when administered orally alone and in combination with olaparib and to define the MTD or MAD for RP-3467 monotherapy and the RP2D for the combination
  • Characterize the PK profile of RP-3467 alone and in combination with olaparib

Keywords

Advanced Solid Tumor, Neoplasms, Olaparib, RP-3467 at assigned dose and schedule, Olaparib 200-300 mg BID, daily, RP-3467 monotherapy

Eligibility

You can join if…

Open to people ages 18 years and up

  • Male or female participants ≥18 years of age at the time of signing the informed consent
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Participant must have one of the following that has progressed or was non-responsive to prior systemic therapy and for which no standard or available known therapeutic option exists:
    1. locally advanced or metastatic epithelial ovarian cancer (including fallopian tube or primary peritoneal), or
    2. metastatic breast cancer, or
    3. metastatic castration-resistant prostate cancer (mCRPC), or
    4. pancreatic adenocarcinoma
  • Measurable disease per RECIST v1.1 (exceptions for participants with non-measurable but evaluable disease [per RECIST and or PSA/CA-125])
  • Next generation sequencing (NGS) report demonstrating eligible tumor biomarker
  • Provision of archival tumor tissue, or if adequate archival tumor tissue is not available, provision of a fresh biopsy if there is a lesion that can be safely biopsied
  • Acceptable organ function at Screening
  • Acceptable hematologic function at Screening
  • Life expectancy ≥12 weeks after the start of the treatment according to the Investigator's judgment

You CAN'T join if...

  • History or current condition, therapy, or laboratory abnormality that might confound the study results, or interfere with the patient's participation for the full duration of the study treatment.
  • Uncontrolled, symptomatic brain metastases.
  • Presence of other known active invasive cancers
  • History of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) diagnosis
  • Prior therapy with a Polθ inhibitor other than RP-3467

Locations

  • Participating Site #1025 accepting new patients
    San Francisco California 94158 United States
  • Participating Site # 1001 accepting new patients
    Houston Texas 77030 United States

Lead Scientist at UCSF

  • Rahul Aggarwal
    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
NCT06560632
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 52 study participants
Last Updated