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Open-Label Study to Evaluate the Safety, Tolerability, PK, and Efficacy of INX-315 in Patients With Advanced Cancer

Study to test safety and effects of INX-315 for advanced cancer.

Recruiting
18 years and older
All
Phase 1/2

Incyclix Bio is testing a new drug called INX-315 for patients with advanced cancer. This drug is a small molecule inhibitor, which means it can block certain proteins involved in cancer growth. The study is divided into three parts:

  • Part A: Tests different doses of INX-315 to find the safest dose. Up to 60 patients with advanced cancer will participate.
  • Part B: Focuses on patients with advanced ovarian cancer. This part will test at least two doses selected from Part A.
  • Part C: Involves patients with a specific type of breast cancer and tests INX-315 with other treatments.

To join, patients must have advanced cancer that has worsened after standard treatments. They should have good organ function and no history of certain diseases or conditions. They should not have taken similar treatments before.

  • Study involves multiple visits over an extended period.
  • Potential benefits include access to a new cancer treatment.
  • Risks include side effects and the possibility of not responding to the treatment.
Study details
    Breast Cancer
    Breast Cancer Metastatic
    Hormone Receptor Positive Tumor
    Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
    Ovarian Cancer
    CCNE1 Amplification
    Solid Tumor
    Advanced Cancer
    Metastatic Cancer

NCT05735080

Incyclix Bio

3 May 2025

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What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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