Our Goal is to Transform Care for Patients with GIST
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.
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.
We are developing therapies to treat the large majority of GIST tumors driven by mutations in the KIT enzyme. This approach utilizes a primary therapy (IDRX-42) which has the potential to be the best-in-class treatment for these tumors. IDRX-42 is designed to potently inhibit both the primary mutations that drive the progression of most cases of GIST, and also the secondary mutations that contribute to loss of response to treatment. We are also pursuing a second therapy (IDRX-73) designed to selectively enhance activity against a key drug resistance mutation, which we hope will offer superior benefit to some patients. We aim to intervene earlier in the course of patients' disease, to address and prevent the emergence of these mutations. We believe this approach has the potential to offer prolonged, durable, and better tolerated therapeutic responses for people living with GIST.
Patient Organizations
These groups may offer information, resources and support for patients living with GIST.
Currently Enrolling Clinical Trials
IDRX-42
IDRx is conducting a Phase 1 first-in-human study of IDRX-42, a small molecule tyrosine kinase inhibitor designed to target key genetic driver and resistance mutations in GIST. The study is currently enrolling adult participants with metastatic and/or unresectable GIST in the U.S. and Europe.
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