Testing a new drug for advanced solid tumors

Phase 1 Trial of the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Clinical Activity of RP-1664 in Participants With Advanced Solid Tumors

This study is testing a new drug called RP-1664 to see if it is safe and effective for people with advanced solid tumors.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 12 Years to 100 Years
• Sex: All
• Sponsor: Repare Therapeutics (industry)
• Drugs / interventions: Chemotherapy
• Locations: 5 sites (San Francisco, California and 4 other locations)
• Trial ID: NCT06232408 on ClinicalTrials.gov

What this trial studies

This Phase 1 clinical trial aims to determine the safety and tolerability of the PLK4 inhibitor RP-1664 in patients with advanced solid tumors. It involves a multi-center, open-label, dose-escalation approach to establish the maximum tolerated dose and schedule for further investigation. The study will also evaluate the pharmacokinetics and pharmacodynamics of RP-1664, along with its preliminary anti-tumor activity. Additionally, biomarker responses will be explored in relation to the drug's exposure.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 12 and older with advanced solid tumors that have progressed despite available treatments.

Not a fit: Patients with early-stage tumors or those who have not exhausted standard treatment options may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors that have not responded to existing therapies.

How similar studies have performed: Other studies involving PLK4 inhibitors have shown promise, suggesting potential for success in this novel approach.

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.

Where this trial is running

San Francisco, California and 4 other locations

• Participating Site 1025 — San Francisco, California, United States (RECRUITING)
• Participating Site 1012 — New Haven, Connecticut, United States (RECRUITING)
• Participating Site 1008 — New York, New York, United States (RECRUITING)
• Participating Site 1004 — New York, New York, United States (RECRUITING)
• Participating Site 4001 — Copenhagen, Denmark (RECRUITING)

Study contacts

• Study coordinator: Joseph O'Connell, MD

Conditions: Advanced Solid Tumor