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PLK4 Inhibitor

RP-1664 for Solid Tumors

Phase 1
Recruiting
Research Sponsored by Repare Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up about 36 months
Awards & highlights

Study Summary

"This trial aims to find a safe and well-tolerated dose of a new drug called RP-1664 that is taken by mouth. The study will also look at how the drug is absorbed and

Who is the study for?
This trial is for men and women aged 12 or older with advanced solid tumors that have worsened after treatment, or didn't respond to previous therapies. They should be able to perform daily activities with ease or only slight difficulty (ECOG score of 0-1), have a life expectancy of at least 4 months, and must have measurable disease according to specific criteria. Participants under 18 must weigh at least 40 kg.Check my eligibility
What is being tested?
The study is testing the safety and appropriate dose of RP-1664, an oral drug designed to inhibit PLK4, which may play a role in tumor cell growth. It will also look into how the body processes the drug (pharmacokinetics), how it affects the body (pharmacodynamics), and its preliminary effectiveness against tumors.See study design
What are the potential side effects?
Specific side effects are not listed here but generally could include reactions related to drug intake such as nausea, fatigue, allergic reactions, changes in blood counts or liver enzymes indicative of organ stress or damage.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~about 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and about 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose Limiting Toxicities to determine a maximum tolerated dose and schedule of RP-1664 based on safety and tolerability as measured by CTCAE v5.0, pharmacokinetic parameters, pharmacodynamic readouts and efficacy data per RECIST or INRC criteria
Incidence and severity of treatment-emergent adverse events (TEAEs) as assessed per NCI CTCAE v5.0 criteria
Secondary outcome measures
To assess the PK parameters of RP-1664 in the fed and fasted states by measurement of plasma concentrations of RP-1664 with calculation of maximum observed plasma concentration (Cmax).
To assess the preliminary anti-tumor activity of RP-1664 in participants with molecularly selected advanced solid tumors treated at pharmacologically active dose ranges. Anti-tumor activity will be measured by ORR according to RECIST 1.1 and INRC.

Trial Design

1Treatment groups
Experimental Treatment
Group I: RP-1664Experimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Repare TherapeuticsLead Sponsor
8 Previous Clinical Trials
1,164 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total number of individuals actively engaged in this medical study?

"Indeed, as documented on clinicaltrials.gov, this trial is presently seeking participants. Originally shared on February 14th, 2024 and most recently modified on March 6th, 2024, the study aims to enroll 80 individuals from a single site."

Answered by AI

Are there any available vacancies for patient participation in this clinical trial?

"Indeed, the details outlined on clinicaltrials.gov indicate that this particular research endeavor is actively seeking potential participants. This investigation became accessible for recruitment on February 14th, 2024 and underwent its latest revision on March 6th, 2024. The study aims to enlist a total of 80 individuals from a singular designated site."

Answered by AI

Can individuals above the age of 65 participate in this clinical trial?

"Patients aged between 12 and a centenarian are eligible for recruitment in this study. Notably, there exist 319 clinical trials catering to minors below the age of legal consent and an additional 2510 focused on elderly participants over the age of retirement."

Answered by AI

Has RP-1664 received approval from the FDA?

"Given that this research is at a Phase 1 stage, the safety rating for RP-1664 from our team at Power stands at 1."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
LIONS (PLK4 Inhibitor in Advanced Solid Tumors)
2024. "LIONS (PLK4 Inhibitor in Advanced Solid Tumors)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06232408.
~53 spots leftby Jan 2027
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