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Omx-0407

A new drug called OMX-0407 is currently being studied in clinical trials for patients with solid tumors that cannot be removed surgically. This article will provide an overview of the ongoing research, including the study’s purpose, design, and expected outcomes. The information presented here is based on a Phase I/Ib clinical trial aimed at evaluating the safety, effectiveness, and proper dosing of OMX-0407 in patients with previously treated solid tumors.

Table of Contents

What is OMX-0407?

OMX-0407 is a new drug being studied for the treatment of solid tumors that cannot be surgically removed[1]. It belongs to a class of drugs called salt-inducible kinase inhibitors. Kinases are proteins in our body that help control various cell functions. By inhibiting specific kinases, OMX-0407 may be able to slow down or stop the growth of cancer cells.

How is OMX-0407 Being Studied?

OMX-0407 is currently being investigated in a clinical trial that has two main phases[1]:

  1. Dose Escalation Phase (Phase I): This initial phase aims to determine the safety of different doses of OMX-0407. Researchers start with a low dose and gradually increase it to find the highest dose that can be given safely.
  2. Dose Expansion Phase (Phase Ib): Once a safe dose is determined, more patients are given this dose to further evaluate its effectiveness, safety, and tolerability.

What Conditions Does OMX-0407 Target?

OMX-0407 is being studied in patients with previously treated solid tumors that cannot be removed surgically[1]. The study is particularly interested in its effects on several types of cancer, including:

  • Renal Cell Cancer: A type of kidney cancer
  • Non-Small Cell Lung Cancer: The most common type of lung cancer
  • Urothelial Cancer: Cancer that typically occurs in the urinary system
  • Angiosarcoma: A rare cancer that forms in the lining of blood vessels and lymph vessels

How is OMX-0407 Administered?

OMX-0407 is taken orally (by mouth)[1]. In the dose escalation phase, patients start with a daily dose of 20 mg, split into two 10 mg doses taken twice a day. In the expansion phase, patients receive 100 mg twice daily. The exact dosing may be adjusted based on the results of the study.

What Are the Study Goals?

The main goals of the study include[1]:

  • Identifying the highest safe dose of OMX-0407
  • Determining how well OMX-0407 works against different types of solid tumors
  • Understanding how the body processes OMX-0407 (pharmacokinetics)
  • Assessing the drug’s impact on patients’ quality of life

What Are the Potential Benefits?

While it’s too early to know for certain, researchers hope that OMX-0407 may provide several benefits for cancer patients[1]:

  • Tumor Shrinkage: The study will measure how many patients experience tumor shrinkage (objective response rate).
  • Longer Survival: Researchers will track how long patients live without their cancer getting worse (progression-free survival) and overall survival times.
  • Quality of Life Improvements: The study will assess whether OMX-0407 helps improve patients’ overall well-being and daily functioning.

What Are the Side Effects?

As with any new drug, understanding the side effects of OMX-0407 is a crucial part of the study[1]. The researchers will be closely monitoring for any adverse events, particularly those that might limit the dose that can be given safely (dose-limiting toxicities). The specific side effects are not yet known and will be determined through the course of the study.

Future Research

Beyond the main goals, the study also aims to explore several other important aspects of OMX-0407[1]:

  • Target Kinase Inhibition: Researchers will examine how OMX-0407 affects specific kinases and T cells (a type of immune cell) in blood, skin, and tumor samples.
  • Metabolite Analysis: The study will investigate how OMX-0407 is broken down in the body and what byproducts (metabolites) are produced.
  • Tumor Biology: By analyzing tumor samples before and after treatment, researchers hope to understand which patients might benefit most from OMX-0407.

These additional investigations may help guide future research and potentially lead to more personalized treatment approaches for cancer patients.

Aspect Details
Drug Name OMX-0407
Trial Phase Phase I/Ib
Target Condition Previously treated unresectable solid tumors
Administration Oral, twice daily
Initial Dose 20 mg daily (10 mg twice daily)
Expansion Phase Dose 100 mg twice daily
Primary Outcomes Identify dose-limiting toxicities and objective response rate
Secondary Outcomes Maximum tolerated dose, safety, tolerability, pharmacokinetics, duration of response, progression-free survival, overall response rates, overall survival, quality of life
Study Duration Up to approximately 3 years

FAQ

  • What is OMX-0407? OMX-0407 is a new drug being tested in clinical trials for patients with solid tumors that cannot be surgically removed. It is a salt-inducible kinase inhibitor, which means it targets specific proteins in cancer cells.
  • What is the main purpose of this clinical trial? The main purpose of this clinical trial is to determine the safety of different doses of OMX-0407 in the dose escalation phase, and to evaluate its effectiveness, safety, and tolerability at a specific dose in the expansion phase.
  • How is the drug administered to patients? OMX-0407 is administered orally (by mouth) to patients. In the expansion phase, patients receive a dose of 100 mg twice daily.
  • What types of cancer are being studied in this trial? The trial focuses on patients with previously treated solid tumors that cannot be surgically removed. Specific cancer types mentioned include renal cell cancer, non-small cell lung cancer, urothelial cancer, and angiosarcoma.
  • How long does the study last? The study is estimated to last up to approximately 3 years. During this time, patients will be evaluated regularly, with some assessments occurring every 4 or 12 weeks.

Ongoing Clinical Trials on Omx-0407

  • Study of OMX-0407 for Patients with Previously Treated Unresectable Solid Tumors

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Spain

Glossary

  • Solid Tumor: A mass of tissue that doesn't contain cysts or liquid areas. Solid tumors may be benign (not cancer) or malignant (cancer). Examples include carcinomas and sarcomas.
  • Salt-inducible Kinase Inhibitor: A type of drug that blocks the action of specific enzymes called salt-inducible kinases, which are involved in various cellular processes including cancer growth.
  • Dose Escalation: A method in clinical trials where the dose of a drug is gradually increased to find the optimal balance between its effectiveness and side effects.
  • Maximum Tolerated Dose: The highest dose of a drug that can be given without causing unacceptable side effects.
  • Pharmacokinetics: The study of how a drug moves through the body, including how it's absorbed, distributed, metabolized, and eliminated.
  • Objective Response Rate: The proportion of patients whose cancer shrinks or disappears after treatment.
  • Progression-Free Survival: The length of time during and after treatment that a patient lives with cancer without it getting worse.
  • Overall Survival: The length of time from the start of treatment that patients are still alive.
  • RECIST 1.1: Response Evaluation Criteria in Solid Tumors version 1.1, a standard way to measure how well a cancer patient responds to treatment.
  • Dose-Limiting Toxicity: Side effects of a drug that are severe enough to prevent an increase in dosage or require a decrease in dosage.

References