What side effects are associated with this type of intervention?

Common treatments for solid tumors include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy agents like gemcitabine and docetaxel can cause side effects such as neutropenia, fatigue, neuropathy, and gastrointestinal issues like nausea and diarrhea. Targeted therapies, such as tyrosine kinase inhibitors (e.g., lapatinib), often lead to diarrhea, rash, and hepatotoxicity. Immunotherapies, including checkpoint inhibitors like nivolumab, can result in immune-related adverse events such as pneumonitis, colitis, and endocrinopathies. While specific data on PLK4 inhibitors like RP-1664 is limited, it is expected that they may share similar side effects with other targeted therapies, including gastrointestinal disturbances and potential hematologic toxicities.

What prior FDA approvals exist?

The FDA has approved several kinase inhibitors for the treatment of solid tumors. Notable examples include tyrosine kinase inhibitors (TKIs) like pazopanib, which is used for soft tissue sarcoma, and eribulin, approved for advanced liposarcoma and leiomyosarcoma. These drugs target specific pathways involved in tumor growth and proliferation, similar to the investigational PLK4 inhibitor RP-1664. Additionally, other kinase inhibitors such as lapatinib and neratinib have been approved for HER2-positive metastatic breast cancer, demonstrating the broad application of kinase inhibition in solid tumor treatment.

What other types of research exist?

Promising novel alternatives for solid tumor treatment in 2024 include: 1) Pembrolizumab (an immune checkpoint inhibitor) which has shown efficacy in various solid tumors, 2) Atezolizumab plus Bevacizumab, particularly for renal cell carcinoma, 3) Nivolumab plus Ipilimumab, which has demonstrated effectiveness in melanoma and renal cell carcinoma, and 4) Talimogene laherparepvec (T-VEC) combined with Pembrolizumab for advanced melanoma.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ about 36 months

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

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for solid tumors include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by killing rapidly dividing cells, which includes cancer cells, but also affects normal cells, leading to side effects. Targeted therapies, such as PLK4 inhibitors like RP-1664, specifically target molecular abnormalities in cancer cells, thereby inhibiting tumor growth with potentially fewer side effects. Immunotherapy boosts the body's immune system to recognize and destroy cancer cells. Understanding these mechanisms is crucial for solid tumor patients as it helps in selecting the most appropriate treatment based on the tumor's specific characteristics, potentially improving outcomes and minimizing adverse effects.

LAPTM4B is a novel diagnostic and prognostic marker for lung adenocarcinoma and associated with mutant EGFR.Identifying differentially expressed genes and screening small molecule drugs for lapatinib-resistance of breast cancer by a bioinformatics strategy.Inhibition of polo-like kinase 1 leads to the suppression of osteosarcoma cell growth in vitro and in vivo.

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Who is running the clinical trial?

Repare TherapeuticsLead Sponsor

8 Previous Clinical Trials

1,164 Total Patients Enrolled

~53 spots leftby Jan 2027

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