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Art0380 Mesilate

ART0380 Mesilate is an innovative drug currently being studied in clinical trials for patients with advanced or metastatic solid tumors. This article will provide an overview of the ongoing research, including the drug’s potential benefits, safety profile, and its use alone or in combination with other treatments. The trials aim to evaluate ART0380’s effectiveness in various cancer types and its potential to improve outcomes for patients with limited treatment options.

Table of Contents

What is ART0380 MESILATE?

ART0380 MESILATE is an investigational drug being developed by Artios Pharma Limited for the treatment of advanced or metastatic solid tumors[1]. It is also known by other names such as IACS-30380 mesilate and ART0380 mesylate[1]. This medication is currently being studied in clinical trials to evaluate its safety and effectiveness in treating various types of cancer.

How does it work?

ART0380 MESILATE is classified as an ATR kinase inhibitor[1]. ATR (Ataxia Telangiectasia and Rad3-related) is a protein that plays a crucial role in DNA damage response. By inhibiting ATR kinase, ART0380 MESILATE may interfere with cancer cells’ ability to repair DNA damage, potentially making them more vulnerable to other cancer treatments or causing them to die.

What conditions does it treat?

ART0380 MESILATE is being investigated for the treatment of several types of advanced or metastatic solid tumors, including:

  • High-grade serous ovarian cancer
  • Fallopian tube cancer
  • Primary peritoneal carcinoma
  • Endometrial cancer
  • Colorectal cancer (CRC)
  • Other solid tumors with specific genetic alterations[1]

The drug is particularly being studied in patients whose cancers have alterations in the ATM gene, which may make them more responsive to this treatment[1].

Clinical Trial Overview

ART0380 MESILATE is currently being evaluated in a Phase I/IIa clinical trial. This study aims to assess the safety, tolerability, and preliminary effectiveness of the drug when given alone or in combination with other cancer treatments[1]. The trial includes several parts:

  • Part A: Evaluating ART0380 MESILATE alone and in combination with gemcitabine or irinotecan
  • Part B1: Studying ART0380 MESILATE in patients with solid tumors that have ATM gene alterations
  • Part B2: Comparing ART0380 MESILATE plus gemcitabine to gemcitabine alone in platinum-resistant ovarian cancer
  • Parts B3, B4, and B5: Further evaluating ART0380 MESILATE in various solid tumors[1]

Potential Benefits

While the full benefits of ART0380 MESILATE are still being investigated, the drug shows promise in several areas:

  • It may be effective against cancers that have become resistant to other treatments, such as platinum-resistant ovarian cancer[1].
  • It could potentially enhance the effectiveness of other cancer treatments when used in combination[1].
  • It may be particularly beneficial for patients with specific genetic alterations, such as those in the ATM gene[1].

Administration

ART0380 MESILATE is administered orally in tablet form[1]. The exact dosing schedule and duration of treatment are still being determined through the clinical trials. Patients in the trial may receive the drug alone or in combination with other cancer treatments, depending on their specific situation and the part of the trial they are enrolled in.

Safety Considerations

As with any investigational drug, the full safety profile of ART0380 MESILATE is still being established. The clinical trial is carefully monitoring for any side effects or adverse reactions. Some general considerations for patients participating in the trial include:

  • Patients should not be pregnant, breastfeeding, or planning to become pregnant during the study or for several months after[1].
  • Patients should not have certain pre-existing medical conditions, such as significant cardiovascular disease or ongoing interstitial lung disease[1].
  • Patients should inform their doctor about all medications they are taking, as there may be interactions with other drugs[1].

It’s important to note that as an investigational drug, ART0380 MESILATE is not yet approved for general use and is only available through clinical trials. Patients interested in this treatment should discuss their options with their oncologist to determine if they might be eligible for a clinical trial.

Aspect Details
Drug Name ART0380 Mesilate
Drug Type ATR Kinase Inhibitor
Administration Oral tablet
Target Conditions Advanced or metastatic solid tumors, including ovarian, fallopian tube, peritoneal, endometrial, and colorectal cancers
Study Phase Phase I/IIa
Study Design Open-label, multi-center study
Treatment Approaches Monotherapy and combination therapy with gemcitabine or irinotecan
Primary Objectives Safety, tolerability, pharmacokinetics, and preliminary efficacy
Key Endpoints Incidence of dose-limiting toxicities, adverse events, progression-free survival
Patient Selection Includes patients with specific genetic alterations (e.g., ATM gene alterations) and those resistant to platinum-based therapies

FAQ

  • What is ART0380 Mesilate? ART0380 Mesilate is an investigational drug being studied for the treatment of advanced or metastatic solid tumors. It is an ATR kinase inhibitor, which means it targets a specific protein involved in cancer cell growth and survival.
  • What types of cancer is ART0380 being tested for? ART0380 is being tested for various types of advanced or metastatic solid tumors, including ovarian cancer, fallopian tube cancer, primary peritoneal cancer, endometrial cancer, and colorectal cancer. It is also being studied in patients with tumors that have specific genetic alterations.
  • How is ART0380 administered? ART0380 is administered orally in tablet form. This means patients can take the medication by mouth, which is generally more convenient than other forms of cancer treatment like intravenous infusions.
  • Is ART0380 being tested alone or in combination with other drugs? ART0380 is being tested both as a single agent (monotherapy) and in combination with other drugs. The clinical trials are evaluating its use alone and in combination with gemcitabine or irinotecan, which are existing chemotherapy drugs.
  • What are the main goals of the ART0380 clinical trials? The main goals of the ART0380 clinical trials are to assess the safety and tolerability of the drug, determine the appropriate dosage, evaluate its effectiveness in treating various types of cancer, and study how the drug behaves in the body (pharmacokinetics). The trials also aim to identify potential biomarkers that may predict which patients are most likely to benefit from the treatment.

Ongoing Clinical Trials on Art0380 Mesilate

  • Study on the Safety and Effectiveness of ART0380 Alone or with Gemcitabine or Irinotecan for Patients with Advanced or Metastatic Solid Tumors

    Recruiting

    2 1 1 1
    Investigated drugs:
    France Spain

Glossary

  • ATR Kinase Inhibitor: A type of drug that blocks the activity of the ATR protein, which is involved in DNA repair and cell cycle regulation in cancer cells.
  • Advanced or Metastatic Solid Tumors: Cancers that have spread from their original site to other parts of the body or have grown significantly and cannot be completely removed by surgery.
  • Pharmacokinetics (PK): The study of how a drug moves through the body, including how it's absorbed, distributed, metabolized, and eliminated.
  • RECIST: Response Evaluation Criteria in Solid Tumors, a standard way to measure how well a cancer patient responds to treatment.
  • Dose-Limiting Toxicity (DLT): Side effects of a drug that are severe enough to prevent increasing the dose or require a dose reduction.
  • Maximum Tolerated Dose (MTD): The highest dose of a drug that can be given without causing unacceptable side effects.
  • Recommended Phase II Dose (RP2D): The dose of a drug determined to be safe and potentially effective, which is then used in further studies.
  • Progression-Free Survival (PFS): The length of time during and after treatment that a patient lives with cancer without it getting worse.
  • Objective Response Rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment.
  • Duration of Response (DOR): The length of time that a tumor continues to respond to treatment without growing or spreading.

References

  1. http://clinicaltrials.eu/trial/study-on-the-safety-and-effectiveness-of-art0380-alone-or-with-gemcitabine-or-irinotecan-for-patients-with-advanced-or-metastatic-solid-tumors/