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Our Mission

We are committed to transforming the lives of patients with GIST. At IDRx, we believe that the best treatments for patients target the full range of tumor biology.

Our mission is to improve the lives of patients living with GIST and other cancers that have well-characterized biology and significant unmet medical need. At IDRx, we believe that the best treatments for patients target the full range of tumor biology. IDRX is inspired by the success of therapies that address the full range of disease mechanisms, and that have delivered transformative benefit to the lives of people living with serious conditions.

Our lead program, IDRX-42, is an oral, small molecule KIT TKI designed to selectively target the most prevalent forms of KIT mutations that either drive the initial growth, proliferation, and survival of tumor cells, or confer resistance to currently available therapies.

IDRX-42 has the potential to improve outcomes for patients with GIST as a first- or second-line therapy, where the standards of care have remained unchanged for almost 20 years and significant unmet need remains.

Patient Organizations

These groups may offer information, resources and support for patients living with GIST.

Sarcoma Patient Advocacy Global Network
The Life Raft Group

Currently Enrolling Clinical Trials

StrateGIST 1

IDRx is evaluating IDRX-42 for the treatment of advanced GIST in its ongoing open-label Phase 1/1b clinical trial. Early data support the best-in-class potential of IDRX-42 in patients with GIST. The study is currently enrolling adult participants with metastatic and/or unresectable GIST in the U.S., Europe, and Asia.

Learn More

Expanded Access Policy

Expanded access, also known as “compassionate use,” is a potential pathway that allows patients with serious or immediately life-threatening diseases or conditions to receive an investigational drug for treatment outside of clinical trials when no satisfactory alternative therapy options are available. The following is IDRx’s current expanded access policy for evaluating and responding to requests for expanded access to its investigational drugs in accordance with section 561A of the Federal Food, Drug, and Cosmetic Act:

IDRx is committed to studying and developing our investigational drug candidates through clinical trials designed to generate adequate safety and efficacy data in a comprehensive fashion that may then be used to support regulatory approval of the investigational drugs. This process of clinical trials and regulatory review and approval is intended to ultimately make our therapies more widely available to patients. IDRx encourages patients to speak with their treating physicians about potential treatment options and, when appropriate, to participate in clinical trials.

We understand that, in certain circumstances, patients may not meet the eligibility criteria to participate in a clinical trial and may have exhausted all available treatment options. Currently, IDRx does not have an expanded access program that allows patients to receive our investigational drug candidates outside enrollment in our clinical trials. We encourage you to stay informed regarding our development programs. As more information on the clinical safety and efficacy of our investigational drug candidates becomes available, we will review and may update our policy on expanded access. We may establish different expanded access polices for each investigational drug product.

If you have any questions regarding this policy, please contact IDRx at info@idrx.com. IDRx plans to respond to expanded access inquiries within seven (7) business days of receipt.

As authorized by the 21st Century Cures Act, IDRx may revise this expanded access policy at any time. The availability of this policy or any revised version shall not serve as a guarantee of access to any of our investigational drugs by any individual patient.
April 30th, 2024