Expanded Access Policy

We are committed to conducting clinical trials to evaluate the safety and efficacy of investigational therapies to obtain the necessary marketing approvals that allow physicians to prescribe them so individuals may have broad access.

In some circumstances, a treating physician may make a request to provide an unapproved therapy to a qualifying individual, which must be approved by the U.S. Food and Drug Administration (FDA) and supported by the pharmaceutical manufacturer. This is called an expanded access program (EAP), sometimes known as “compassionate use,” and refers to a potential pathway for a patient with a serious or life-threatening disease or condition to try an investigational therapy outside of a clinical trial when there is no comparable or satisfactory therapy available.

We currently have investigational medicines in our product pipeline for the treatment of cancer. While we understand that some patients may wish to access our unapproved investigational drugs, our goal is to provide access to our medicines at the appropriate time and in a manner that is most beneficial to the relevant patient population.  At this stage of our development, we do not have sufficient evidence of clinical safety and efficacy of our investigational drugs to support an expanded access program. Therefore, OncoC4 does not currently offer an expanded access program. We believe enrollment in our ongoing clinical trials is the safest and most effective way of achieving this goal and we encourage all patients and physicians who are interested in accessing our investigational medicines to visit the clinicaltrials.gov website to find out about enrolling.

OncoC4 may revise this expanded access policy at any time. Additionally, the posting of this policy by OncoC4 does not serve as a guarantee of access to any specific investigational new drug by any individual patient.

If you have any questions, please reach out to us at admin@oncoc4.com.