Our commitment
to patients and

FAMILIES

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.

Our Clinical trial

StrateGIST 1, a first-in-human Phase 1/1b open-label clinical trial, is currently enrolling GIST patients.

The trial is designed to evaluate the safety, tolerability, pharmacokinetics and preliminary antitumor activity of IDRX-42 in adult participants with advanced (metastatic and/or surgically unresectable) GIST. Initial data from the ongoing study support the potential of IDRX-42 to provide meaningful clinical benefit for GIST patients as a second-line therapy.

.

trial site
clinicaltrials.gov

We are here to make a

DIFFERENCE

IDRx partners with leading patient organizations that are dedicated to the causes we care about. Together, we aim to do more for the patient communities we serve, starting with those who suffer from GIST.

visit site
visit site

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 policies for each investigational drug product.

If you have any questions regarding this policy, please contact IDRx at info@www.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

learn more