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Davutamig

Davutamig, also known as REGN5093, is an investigational drug being studied for the treatment of advanced non-small cell lung cancer (NSCLC) with MET alterations. This article explores the ongoing clinical trials evaluating the safety, effectiveness, and potential benefits of Davutamig for patients who have exhausted other available treatment options.

Table of Contents

What is DAVUTAMIG?

DAVUTAMIG, also known as REGN5093, is an investigational medication being developed for the treatment of advanced non-small cell lung cancer (NSCLC) with specific genetic alterations[1]. It is classified as a bispecific antibody, which means it can target two different molecules simultaneously, potentially enhancing its effectiveness in fighting cancer[1].

Target Condition: MET-Altered Non-Small Cell Lung Cancer

DAVUTAMIG is specifically designed to treat MET-altered non-small cell lung cancer (NSCLC)[1]. NSCLC is a type of lung cancer that accounts for the majority of lung cancer cases. “MET-altered” refers to cancers that have specific changes in the MET gene, which can drive cancer growth. These alterations can include:

  • MET-exon14 gene mutations: Changes in a specific part of the MET gene
  • MET gene amplification: An increase in the number of copies of the MET gene
  • Elevated MET protein expression: Higher than normal levels of the MET protein on cancer cells

These genetic changes can make the cancer more aggressive, but they also provide a target for treatments like DAVUTAMIG[1].

Clinical Trial Overview

DAVUTAMIG is currently being studied in a Phase 1/2 clinical trial[1]. This trial is designed to evaluate several aspects of the drug:

Phase 1 Objectives:

  • Assess the safety and tolerability of DAVUTAMIG
  • Study how the drug behaves in the body (pharmacokinetics)
  • Determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D)
  • Evaluate preliminary anti-tumor activity

Phase 2 Objectives:

  • Assess the preliminary anti-tumor activity by measuring the objective response rate (ORR)
  • Further evaluate safety and tolerability
  • Continue to study the drug’s behavior in the body

Both phases will also look at the drug’s immunogenicity, which is the potential for the body to produce antibodies against the drug[1].

How DAVUTAMIG Works

As a bispecific antibody, DAVUTAMIG is designed to target the MET protein, which is often overexpressed or altered in certain types of lung cancer. By binding to MET, DAVUTAMIG may help to inhibit cancer cell growth and survival. The specific mechanism of action is still being studied as part of the ongoing clinical trial[1].

Eligibility Criteria

To participate in the DAVUTAMIG clinical trial, patients must meet certain criteria[1]:

Inclusion Criteria:

  • Confirmed advanced (unresectable or metastatic) NSCLC
  • Have exhausted all approved available therapies
  • Documented presence of MET alterations (MET-exon14 mutation, MET gene amplification, or elevated MET protein expression)
  • Willing to provide tumor tissue samples

Exclusion Criteria:

  • Recent treatment with other systemic therapies (within 2 weeks or 5 half-lives)
  • Ongoing severe side effects from previous treatments
  • Recent radiation therapy or major surgery (within 14 days)
  • Untreated brain metastases or certain other central nervous system issues
  • For some parts of the study, prior treatment with MET-targeted therapies may exclude participation

Potential Benefits

While the effectiveness of DAVUTAMIG is still being evaluated, the clinical trial aims to assess its potential benefits, including[1]:

  • Objective response rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment
  • Duration of response (DOR): How long the cancer remains controlled after responding to treatment
  • Disease control rate (DCR): The percentage of patients whose cancer shrinks or remains stable
  • Progression-free survival (PFS): The length of time during and after treatment that the cancer does not grow or spread
  • Overall survival (OS): How long patients live after starting treatment

Safety and Side Effects

As DAVUTAMIG is still in clinical trials, its full safety profile is not yet known. The study is carefully monitoring for any side effects, including[1]:

  • Treatment-emergent adverse events (TEAEs)
  • Serious adverse events (SAEs)
  • Adverse events of special interest (AESIs)
  • Laboratory abnormalities

Patients in the trial are closely monitored for any potential side effects or safety concerns.

Administration

DAVUTAMIG is administered as an intravenous (IV) infusion. This means the drug is given directly into a vein. The exact dosing schedule and duration of treatment are being determined as part of the clinical trial[1].

Aspect Details
Drug Name Davutamig (REGN5093)
Type of Drug Bispecific antibody
Target Condition Advanced non-small cell lung cancer (NSCLC) with MET alterations
Trial Phase Phase 1/2
Main Objectives Assess safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity
Key Eligibility Criteria Confirmed NSCLC, exhausted available therapies, presence of MET alterations
Primary Endpoints Dose-limiting toxicities, adverse events, pharmacokinetics, objective response rate
Administration Intravenous infusion

FAQ

  • What is Davutamig (REGN5093)? Davutamig, also known as REGN5093, is an investigational bispecific antibody being studied for the treatment of advanced non-small cell lung cancer (NSCLC) with MET alterations. It is designed to target specific changes in the MET gene or protein that are found in some lung cancers.
  • What type of cancer is being studied in these clinical trials? The clinical trials are focusing on advanced non-small cell lung cancer (NSCLC) with MET alterations. This includes patients whose cancer has specific changes in the MET gene or elevated levels of the MET protein.
  • Who is eligible to participate in these clinical trials? Eligible participants include patients with histologically confirmed advanced NSCLC who have exhausted all approved available therapies. They must have previously documented MET alterations, such as MET-exon14 gene mutations, MET gene amplification, or elevated MET protein expression.
  • What are the main goals of the Davutamig clinical trials? The main goals of the trials are to assess the safety and tolerability of Davutamig, determine the appropriate dosage, and evaluate its effectiveness in treating advanced NSCLC. The studies will measure factors such as tumor response, duration of response, and overall survival.
  • How is Davutamig administered in the clinical trials? Davutamig is administered as a powder for solution for injection, given through intravenous (IV) infusion. The specific dosing schedule and administration details are determined as part of the clinical trial process.

Ongoing Clinical Trials on Davutamig

  • Study of Davutamig (REGN5093) for Patients with Advanced Non-Small Cell Lung Cancer with MET Alterations

    Not recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    France

Glossary

  • Non-small cell lung cancer (NSCLC): A type of lung cancer that is the most common form of the disease, accounting for about 80-85% of all lung cancers. It grows and spreads more slowly than small cell lung cancer.
  • MET alterations: Changes in the MET gene or protein that can contribute to cancer growth. These can include MET-exon14 gene mutations, MET gene amplification, or elevated MET protein expression.
  • Bispecific antibody: A type of engineered antibody that can bind to two different targets simultaneously, potentially enhancing its therapeutic effect.
  • Phase 1/2 study: A clinical trial that combines elements of both Phase 1 (initial safety testing) and Phase 2 (preliminary effectiveness testing) studies to evaluate a new treatment.
  • Maximum tolerated dose (MTD): The highest dose of a drug that can be given without causing unacceptable side effects.
  • Recommended Phase 2 dose (RP2D): The dose of a drug determined to be safe and potentially effective, which is then used in further studies.
  • Objective response rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment.
  • RECIST 1.1: Response Evaluation Criteria in Solid Tumors, version 1.1 – a standardized way to measure how well a cancer patient responds to treatment.
  • Pharmacokinetics (PK): The study of how a drug moves through the body, including how it's absorbed, distributed, metabolized, and excreted.
  • Anti-drug antibodies (ADA): Antibodies produced by the body's immune system in response to a therapeutic drug, which can potentially reduce the drug's effectiveness.

References

  1. http://clinicaltrials.eu/trial/study-of-davutamig-regn5093-for-patients-with-advanced-non-small-cell-lung-cancer-with-met-alterations/