TERMINATED

LIONS (PLK4 Inhibitor in Advanced Solid Tumors)

Conditions

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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

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

Quick Facts

Study Start:2024-02-14

Study Completion:2025-08-27

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:TERMINATED

Study ID

NCT06232408

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:12 Years to 100 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Written informed consent or assent, according to local guidelines, signed and dated by the patient or legal guardian prior to the performance of any study-specific procedures, sampling, or analyses. * Male or female and ≥ 12 years-of-age at the time of signature of the consent or assent, and are at least 6th grade reading level to consent; participants \< 18 years of age must weigh at least 40 kg. * Life expectancy ≥ 4 months. * Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1. * Locally advanced or metastatic solid tumor that has progressed or was nonresponsive or intolerant to available therapies and for which no standard or available curative therapy exists. * Measurable disease as per RECIST v1.1 or INRC. * Existing biomarker profile (tumor tissue or plasma) reported from a local test obtained in a CLIA-certified or equivalent laboratory demonstrating eligible tumor biomarkers. * Available tumor tissue. * Molecularly eligible tumor profile from a CLIA-certified pathology report. * Ability to comply with the protocol and study procedures detailed in the Schedule of Assessments. * Ability to swallow and retain oral medications. * Acceptable organ function at screening. * Acceptable blood counts at screening. * Negative pregnancy test (serum or urine) for females of childbearing potential at Screening and while on study drug. * Resolution of all toxicities of prior treatment or surgery. * Use of highly effective forms of contraception.	* History or current condition (such as transfusion dependent anemia or thrombocytopenia), 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. * Life-threatening illness, medical condition, active uncontrolled infection, or organ system dysfunction or other reasons which, in the investigator's opinion, could compromise the patient's safety. * Uncontrolled, symptomatic brain metastases. * Presence of other known second malignancy with the exception of any cancer that has been in complete remission for ≥ 2 years or completely resected squamous and basal cell carcinomas of the skin. * Patients with active, uncontrolled bacterial, fungal, or viral infection, including hepatitis B virus (HBV), hepatitis C virus (HCV), known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness. * Clinically significant vascular (both arterial and venous) and non-vascular cardiac conditions, active or within 6 months prior to enrollment. * Moderate or severe hepatic impairment (ie, Child-Pugh class B or C). * Uncontrolled high blood pressure. * Chemotherapy, small molecule or biologic antineoplastic agent given within 21 days. * Previously prescribed receptor activator of nuclear factor kappa B ligand (RANKL) inhibitor initiated less than 4 months prior to trial entry. Bisphosphonates are allowed if initiated/administered at least 28 days prior to enrollment. * I-131 Meta-Iodo-Benzyl-Guanidine (MIGB) therapy within 6 weeks prior to initiation of trial treatment. * Prior treatment with a PLK4 inhibitor. * Current treatment with medications that are known to prolong the QT interval.

Inclusion Criteria

Exclusion Criteria

* Written informed consent or assent, according to local guidelines, signed and dated by the patient or legal guardian prior to the performance of any study-specific procedures, sampling, or analyses.
* Male or female and ≥ 12 years-of-age at the time of signature of the consent or assent, and are at least 6th grade reading level to consent; participants \< 18 years of age must weigh at least 40 kg.
* Life expectancy ≥ 4 months.
* Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
* Locally advanced or metastatic solid tumor that has progressed or was nonresponsive or intolerant to available therapies and for which no standard or available curative therapy exists.
* Measurable disease as per RECIST v1.1 or INRC.
* Existing biomarker profile (tumor tissue or plasma) reported from a local test obtained in a CLIA-certified or equivalent laboratory demonstrating eligible tumor biomarkers.
* Available tumor tissue.
* Molecularly eligible tumor profile from a CLIA-certified pathology report.
* Ability to comply with the protocol and study procedures detailed in the Schedule of Assessments.
* Ability to swallow and retain oral medications.
* Acceptable organ function at screening.
* Acceptable blood counts at screening.
* Negative pregnancy test (serum or urine) for females of childbearing potential at Screening and while on study drug.
* Resolution of all toxicities of prior treatment or surgery.
* Use of highly effective forms of contraception.

* History or current condition (such as transfusion dependent anemia or thrombocytopenia), 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.
* Life-threatening illness, medical condition, active uncontrolled infection, or organ system dysfunction or other reasons which, in the investigator's opinion, could compromise the patient's safety.
* Uncontrolled, symptomatic brain metastases.
* Presence of other known second malignancy with the exception of any cancer that has been in complete remission for ≥ 2 years or completely resected squamous and basal cell carcinomas of the skin.
* Patients with active, uncontrolled bacterial, fungal, or viral infection, including hepatitis B virus (HBV), hepatitis C virus (HCV), known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness.
* Clinically significant vascular (both arterial and venous) and non-vascular cardiac conditions, active or within 6 months prior to enrollment.
* Moderate or severe hepatic impairment (ie, Child-Pugh class B or C).
* Uncontrolled high blood pressure.
* Chemotherapy, small molecule or biologic antineoplastic agent given within 21 days.
* Previously prescribed receptor activator of nuclear factor kappa B ligand (RANKL) inhibitor initiated less than 4 months prior to trial entry. Bisphosphonates are allowed if initiated/administered at least 28 days prior to enrollment.
* I-131 Meta-Iodo-Benzyl-Guanidine (MIGB) therapy within 6 weeks prior to initiation of trial treatment.
* Prior treatment with a PLK4 inhibitor.
* Current treatment with medications that are known to prolong the QT interval.

Contacts and Locations

Study Locations (Sites)

Participating Site 1025

San Francisco, California, 94143

United States

Participating Site 1012

New Haven, Connecticut, 06519

United States

Participating Site 1008

New York, New York, 10032

United States

Participating Site 1004

New York, New York, 10065

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 Date2024-02-14

Study Completion Date2025-08-27

Study Record Updates

Study Start Date2024-02-14

Study Completion Date2025-08-27

Terms related to this study

Additional Relevant MeSH Terms

Advanced Solid Tumor