Search / Trial NCT06232408

LIONS (PLK4 Inhibitor in Advanced Solid Tumors)

Launched by REPARE THERAPEUTICS · Jan 22, 2024

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Trial Information

Current as of December 22, 2024

Recruiting

Keywords

ClinConnect Summary

The LIONS trial is studying a new medication called RP-1664, which is designed to treat patients with advanced solid tumors that have not responded to other treatments. The main goal of this study is to find a safe dose of RP-1664 that patients can take orally, and to see how the drug works in the body and if it can help shrink tumors. This is a Phase 1 trial, which means it is one of the first steps in testing this new treatment in people.

To participate in this trial, patients need to be at least 12 years old, have a life expectancy of at least four months, and have a specific type of advanced cancer that hasn’t improved with existing therapies. They should also be able to take oral medications and have acceptable organ function. Before joining, potential participants will need to provide written consent and meet certain health criteria. If someone joins the trial, they can expect close monitoring of their health and treatment effects, which helps researchers learn more about RP-1664's safety and effectiveness.

Gender

ALL

Eligibility criteria

  • Inclusion 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.
  • Exclusion Criteria:
  • • 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.

About Repare Therapeutics

Repare Therapeutics is a clinical-stage biotechnology company focused on leveraging its proprietary synthetic lethality approach to develop innovative cancer therapeutics. The company specializes in identifying and targeting unique vulnerabilities in cancer cells, particularly those with specific genetic mutations, to enhance treatment efficacy and improve patient outcomes. With a robust pipeline of drug candidates and a commitment to precision medicine, Repare Therapeutics aims to transform cancer care through cutting-edge research and development, fostering collaborations across the biopharmaceutical industry to advance its mission of delivering impactful therapies to patients.

Locations

New York, New York, United States

New York, New York, United States

San Francisco, California, United States

New Haven, Connecticut, United States

Copenhagen, , Denmark

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0