Europas førende søgning efter kliniske forsøg

LUNRESERTIB

Clinical trials are studying LUNRESERTIB in people with certain advanced solid tumors. The main goals are to check safety, tolerability, dose levels, and early signs of effect, alone or in combination with other study drugs. These trials focus on patients with specific gene changes or selected cancer types.

Table of contents

Overview of the LUNRESERTIB trial

This is a Phase 1 study of LUNRESERTIB in people with certain advanced solid tumors.[1] The trial is authorised and plans to include 470 participants.[1] The study is looking at LUNRESERTIB alone and in combination with other study drugs, including RP-3500 and Debio 0123.[1]

Who the trial is for

The main group includes patients with advanced solid tumors and specific gene changes, such as CCNE1 amplification or harmful mutations in FBXW7 or another proprietary gene.[1] One part of the study also includes patients with advanced solid tumors carrying either CCNE1 amplification or harmful mutations in FBXW7 or PPP2R1A.[1] Another part focuses on patients with CCNE1 amplification and advanced high-grade serous ovarian, fallopian tube, or primary peritoneal cancer.[1]

What the study is testing

The main goal is to assess the safety and tolerability of LUNRESERTIB.[1] The trial also tries to find the maximum tolerated dose, which is the highest dose that can be given without unacceptable side effects.[1] Researchers then aim to choose a recommended Phase 2 dose and a preferred dosing schedule for later studies.[1]

Several trial modules are included in the study.[1] Module 1 studies LUNRESERTIB alone in eligible advanced solid tumors.[1] Module 2 studies LUNRESERTIB with RP-3500 in molecularly selected advanced solid tumors.[1] Module 4 studies LUNRESERTIB with Debio 0123 in selected advanced solid tumors and also looks at early anti-tumor activity in a group with CCNE1 amplification and certain gynecologic cancers.[1]

Some parts of the study compare a tablet form with a capsule form.[1] Another part checks how food may affect how the tablet is handled by the body, which helps guide future dosing instructions.[1]

What researchers are measuring

The trial measures treatment-emergent adverse events, which are side effects that appear after treatment starts.[1] It also records laboratory tests, vital signs, electrocardiograms (ECGs), physical examinations, and use of other medicines taken during the study.[1]

For dose finding, the study measures dose-limiting toxicities in several modules.[1] It also measures blood levels of LUNRESERTIB and uses pharmacokinetic values such as Cmax, Tmax, AUC, and elimination half-life to understand how the drug behaves in the body.[1]

In the part that looks at anti-cancer activity, researchers measure best percent change in tumor size, overall response rate, duration of response, clinical benefit rate, tumor marker response, and progression-free survival.[1] These results help show whether the treatment may be doing more than just being safe.[1]

Study design and trial parts

This is an interventional study, which means the researchers give a treatment and then observe the results.[1] The study has several modules that answer different questions about LUNRESERTIB, including safety, dose, drug levels, food effects, and early anti-tumor activity.[1]

  • Module 1: Tests LUNRESERTIB alone in advanced solid tumors to learn about safety, tolerability, and the best dose.[1]
  • Module 2: Tests LUNRESERTIB with RP-3500 in molecularly selected advanced solid tumors to study safety and dose finding.[1]
  • Module 3: Compares tablet and capsule forms and checks whether food changes how the tablet is absorbed and processed.[1]
  • Module 4: Tests LUNRESERTIB with Debio 0123 in selected advanced solid tumors and looks for early signs of tumor response in a gynecologic cancer group.[1]

Important terms explained

Solid tumor means a cancer that forms a mass or lump, unlike some blood cancers.[1] Gene amplification means there are extra copies of a gene, which can help doctors select patients for the study.[1] Mutation means a change in a gene, and this trial uses certain gene changes to choose participants.[1]

Overall response rate shows how many patients have a measurable tumor response.[1] Progression-free survival tells how long the cancer stays from getting worse.[1] Pharmacokinetics means how the body absorbs and handles the drug over time.[1]

Trial ID Phase Condition studied Status Enrollment
NCT04855656 Phase 1 Advanced solid tumors with CCNE1 amplification or harmful FBXW7 changes; some parts also study PPP2R1A and high-grade serous ovarian, fallopian tube, or primary peritoneal cancer Authorised 470

FAQ

  • What are the LUNRESERTIB trials trying to find out? They are mainly checking whether LUNRESERTIB is safe and tolerable. The trials also look for the best dose and early signs that the treatment may help against cancer.
  • Who may be included in these trials? The main study includes people with advanced solid tumors and certain gene changes, such as CCNE1 amplification or harmful changes in FBXW7 or PPP2R1A. One part also focuses on advanced high-grade serous ovarian, fallopian tube, or primary peritoneal cancer.
  • What phase are the LUNRESERTIB trials in? The study is a Phase 1 trial. Phase 1 studies are early trials that mainly test safety, tolerability, and dose finding.
  • Is LUNRESERTIB being studied alone or with other drugs? It is being studied both alone and in combination with other study drugs, including RP-3500 and Debio 0123. Some trial parts also compare different tablet and capsule formulations.
  • What results are the researchers measuring? They are measuring side effects, lab tests, vital signs, ECGs, dose-limiting toxicities, drug levels in the blood, tumor shrinkage, response rate, duration of response, clinical benefit, and progression-free survival.

Igangværende kliniske forsøg for LUNRESERTIB

  • Test af kræftmedicinen RP-6306 alene eller sammen med andre lægemidler hos patienter med fremskredne solide tumorer

    Rekrutterer

    1 1
    Undersøgte lægemidler:
    Danmark Frankrig Holland Spanien

Ordliste

  • Phase 1: An early stage of clinical research. The main goal is to learn about safety, tolerability, and the right dose.
  • Advanced solid tumors: Solid cancers that have grown or spread and are usually harder to treat.
  • CCNE1 amplification: A change in a gene where there are too many copies of it. This can help doctors choose patients for a trial.
  • FBXW7: A gene that is checked in this study. Some patients have harmful changes in this gene.
  • PPP2R1A: Another gene included in the trial criteria. Some patients have harmful changes in this gene.
  • Tolerability: How well a person can handle a treatment, especially whether side effects are manageable.
  • Dose-limiting toxicities (DLTs): Side effects that are serious enough to limit how much of a treatment can be given.
  • Maximum tolerated dose (MTD): The highest dose that can usually be given without unacceptable side effects.
  • Recommended Phase 2 dose (RP2D): The dose chosen for later studies after looking at safety and other data.
  • Pharmacokinetics (PK): How the body absorbs, moves, and removes a drug.
  • Overall response rate (ORR): The percentage of patients whose tumors shrink or disappear for a period of time.
  • Progression-free survival (PFS): The length of time a person lives without the cancer getting worse.

Referencer

  1. https://kliniske-forsoeg.dk/forsog/test-af-kraeftmedicinen-rp-6306-alene-eller-sammen-med-andre-laegemidler-hos-patienter-med-fremskredne-solide-tumorer/