ACTIVE_NOT_RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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)

Quick Facts

Study Start:2024-09-17

Study Completion:2028-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06560632

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Locations (Sites)

# 1025, The University of California

San Francisco, California, 94158

United States

# 1011, The Washington University

St Louis, Missouri, 63130

United States

# 1008, Columbia University

New York, New York, 10032

United States

# 1004, Memorial Sloan-Kettering Cancer Center

New York, New York, 10065

United States

# 1001, The University of Texas M.D. Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: Repare Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-17

Study Completion Date2028-12

Study Record Updates

Study Start Date2024-09-17

Study Completion Date2028-12

Terms related to this study

Additional Relevant MeSH Terms

Advanced Solid Tumor