Phase 1 Trial of RP-3467 Alone and in Combination with Olaparib in Participants with Advanced Solid Tumors

Description

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.

Conditions

Advanced Solid Tumor

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Study Overview

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Study Details

Study overview

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.

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)

Phase 1 Trial of RP-3467 Alone and in Combination with Olaparib in Participants with Advanced Solid Tumors

Condition
Advanced Solid Tumor
Intervention / Treatment

-

Contacts and Locations

San Francisco

Participating Site #1025, San Francisco, California, United States, 94158

New York

Participating Site # 1008, New York, New York, United States, 10032

New York

Participating Site # 1004, New York, New York, United States, 10065

Houston

Participating Site # 1001, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Repare Therapeutics,

Study Record Dates

2028-12