Clinical Trials

Incyclix Bio is developing INX-315 as an antineoplastic treatment for patients with cancer. The IND-opening study (Study INX-315-01) is a First-In Human (FIH), Phase 1/2, open label, dose-escalation and dose-expansion study to evaluate the safety, pharmacokinetics (PK), and preliminary antitumor activity of INX-315 in patients with advanced/metastatic cancer. This study will focus on patients that have ER+/HER2- breast cancer that has progressed on a prior CDK4/6i regimen and CCNE1-amplified solid tumors that have progressed on standard of care treatment.

This study will be conducted in the United States and Australia.  For additional information and to find a participating clinical site, please access the clinical trial link below.

You may contact Incyclix Bio for additional information as well, clinicalinfo@incyclixbio.com.

 

Clinicaltrials.gov

Expanded Access Statement

Incyclix Bio (Incyclix) is a next-generation cell cycle control company advancing precision treatments that target the aberrant proliferation driving many cancers. Incyclix is committed to developing groundbreaking treatments for patients living with cancer. Our mission is to bring these therapies to patients as swiftly and safely as possible.  We believe that the best process to access our current drug candidate in development is through participation in a currently enrolling/recruiting clinical trial.

When enrollment into a clinical trial is not an option and all currently available treatment options have been exhausted, an investigational medicine may be provided prior to regulatory approval or commercial availability under a provision referred to as Expanded Access (also known as Compassionate Use) by the U.S. Food and Drug Administration (FDA). An investigational medicine has not yet been approved or cleared by FDA and FDA has not found these products to be safe and effective for their specific use.

Expanded Access is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational drug for treatment outside of a clinical trial when no comparable or satisfactory alternative therapy exists.

FDA considerations for Expanded Access eligibility:

  1. A patient must have a serious disease or condition, or their life is immediately threatened by their disease or condition.
  2. No comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition exists.
  3. Patient enrollment in a clinical trial is not possible.
  4. Based on available clinical data, potential benefits for a patient justify the potential risks of treatment.
  5. Providing the investigational medical product will not interfere with investigational trials that could support a medical product’s development or marketing approval for the treatment indication.
  6. Adequate supply of the investigational drug must be available.

Incyclix will not provide access to our investigational drug(s) to patients until preliminary safety and efficacy data has been collected to support dose selection from our early phase trials.

In the future, Incyclix may decide to make its drug candidates available via Expanded Access, but all requests and inquiries must come directly from the patient’s treating physician; the information will be evaluated and responded to on a case-by-case basis.  Please email all inquiries to Clinicalinfo@incyclixbio.com. All inquiries will receive email confirmation of the request and a response to the request will be provided within 5 business days.