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LUNRESERTIB

LUNRESERTIB is being studied in clinical trials for people with certain advanced solid tumors and selected cancer-related gene changes. These trials mainly look at safety, tolerability, dose finding, and early signs of anti-tumor activity. Some parts also study LUNRESERTIB alone and in combination with other drugs. No references are included in this section.

Table of Contents

Trial overview

The main study of LUNRESERTIB is an interventional trial, which means patients receive a study treatment and researchers follow what happens.[1] It is a Phase 1 trial, so the main goals are to check safety, tolerability, and dose, rather than to prove long-term benefit.[1]

The trial is designed for people with certain advanced solid tumors and specific gene changes, including CCNE1 amplification and harmful mutations in FBXW7 or another proprietary gene.[1]

Who the trials are for

This study includes patients with advanced solid tumors that match the study’s molecular rules, meaning the cancer must have certain gene features.[1] The brief summary also says the study includes patients with CCNE1 amplification or deleterious mutations in FBXW7 or PPP2R1A for one of the combination parts.[1]

One module also focuses on patients with high-grade serous ovarian, fallopian tube, or primary peritoneal cancer when CCNE1 amplification is present.[1] This means the trial is not for all cancer patients, but for selected groups based on tumor type and gene changes.[1]

Study design and trial parts

The study has several modules, and each module asks a different question about LUNRESERTIB.[1] Some modules test LUNRESERTIB alone, while others test it with other drugs such as RP-3500 or Debio 0123.[1]

Module 1 studies LUNRESERTIB alone in eligible advanced solid tumors to assess safety and tolerability and to find the maximum tolerated dose and a recommended Phase 2 dose.[1] This helps researchers learn what dose may be suitable for later studies.[1]

Module 2 studies LUNRESERTIB with RP-3500 in molecularly selected, advanced solid tumors and also aims to define the maximum tolerated dose and recommended Phase 2 dose.[1]

Module 3 includes pharmacokinetic work, which means researchers measure how much LUNRESERTIB is in the blood and how long it stays there.[1] It also compares tablet and capsule forms and looks at whether food changes how the tablet is handled by the body.[1]

Module 4 studies LUNRESERTIB with Debio 0123 in advanced solid tumors with CCNE1 amplification or harmful mutations in FBXW7 or PPP2R1A.[1] This module also looks at early anti-tumor activity in patients with CCNE1-amplified high-grade serous ovarian, fallopian tube, or primary peritoneal cancer.[1]

What the trials measure

The main endpoints are the results the researchers want to measure.[1] In this trial, the key safety measures include treatment-emergent adverse events, laboratory tests, vital signs, electrocardiograms, and use of other medicines taken at the same time.[1]

The study also measures dose-limiting toxicities, which are side effects that may stop the dose from being increased further.[1] For dose-finding parts, the trial looks for the maximum tolerated dose and then the recommended Phase 2 dose.[1]

For the blood-level part of the study, researchers measure pharmacokinetic values such as Cmax (highest blood level), Tmax (time to reach the highest level), AUC (total exposure over time), and elimination half-life, which is how long it takes the body to remove half of the drug.[1]

The trial also measures early signs of benefit, including best percent change in tumor size, overall response rate, duration of response, clinical benefit rate, tumor marker response, and progression-free survival.[1] These outcomes help show whether the cancer shrinks, stays controlled, or grows more slowly.[1]

Trial status and enrollment

The trial is listed as Authorised and has an enrollment of 470 participants.[1] This means the study has approval to proceed and plans to include a relatively large number of patients for an early-phase trial.[1]

Patient-friendly terms

Safety means how well the treatment can be given without causing too much harm.[1] Tolerability means how well patients can handle the treatment and its effects.[1]

Interventional means the researchers give a treatment and watch the results.[1] Molecularly selected means patients are chosen because their cancer has certain gene changes.[1]

ECG stands for electrocardiogram, a test that checks the heart’s electrical activity.[1] PK, or pharmacokinetics, is the study of how the body handles a drug over time.[1]

Trial IDPhaseCondition studiedStatusEnrollment
NCT04855656Phase 1Advanced solid tumors with CCNE1 amplification or deleterious mutations in FBXW7 or other proprietary geneAuthorised470

FAQ

  • What is being studied in LUNRESERTIB trials? The trials study LUNRESERTIB alone and in combinations with other drugs. They focus on safety, tolerability, dose finding, and early anti-tumor activity.
  • Who may be able to join these trials? People with advanced solid tumors may be eligible, especially if their cancer has certain gene changes such as CCNE1 amplification or mutations in FBXW7 or PPP2R1A. One part also studies people with high-grade serous ovarian, fallopian tube, or primary peritoneal cancer.
  • What phase are the LUNRESERTIB trials? The main study is a Phase 1 trial. Phase 1 means the trial is mainly checking safety, side effects, and the best dose to use.
  • What do the trial teams measure? They measure adverse events, lab results, vital signs, ECGs, dose-limiting toxicities, blood levels of LUNRESERTIB, and signs that the cancer may shrink or stop growing.
  • Are the trials only for one cancer type? No. The trial includes advanced solid tumors with specific gene changes, and one part looks at ovarian, fallopian tube, and primary peritoneal cancer. The study is focused on molecularly selected cancers, which means cancers chosen by their gene features.

Ongoing Clinical Trials on LUNRESERTIB

  • Study on the Safety of RP-6306 Alone or with RP-3500 or Debio 0123 for Patients with Advanced Solid Tumors

    Recruiting

    1 1 1
    Investigated drugs:
    Denmark France The Netherlands Spain

Glossary

  • Advanced solid tumors: Solid cancers that have grown or spread and are harder to treat. 'Solid' means a lump or mass, not a blood cancer.
  • CCNE1 amplification: A gene change where the cancer has extra copies of the CCNE1 gene. This can help identify patients for the study.
  • FBXW7 mutation: A change in the FBXW7 gene. The trial includes patients with deleterious, or harmful, mutations in this gene.
  • PPP2R1A mutation: A harmful change in the PPP2R1A gene. Some parts of the trial include patients with this gene change.
  • Phase 1: An early stage of clinical research. The main goal is to learn about safety, tolerability, and dose.
  • Safety: How well a treatment can be given without causing too much harm.
  • Tolerability: How well patients can handle the treatment and its effects.
  • Dose-limiting toxicities (DLTs): Side effects that are serious enough to limit how much of the treatment can be given.
  • Maximum tolerated dose (MTD): The highest dose that most patients can take without unacceptable side effects.
  • Recommended Phase 2 dose (RP2D): The dose chosen for later trials because it seems safe enough and promising.
  • Pharmacokinetics (PK): How the body absorbs, moves, and removes a treatment.
  • Overall response rate (ORR): The percentage of patients whose tumors shrink by a set amount.

References