D3 Bio, Inc., hereafter D3 Bio, is dedicated to developing innovative medicines for patients with serious or life-threatening illnesses or conditions, we are focused on enrolling and conducting the clinical trials necessary to gain regulatory approvals to make our medicines available broadly to patients as quickly as possible.
At the same time, we understand that there are seriously ill patients who will not be eligible for our clinical trials and may not have options for alternative therapies, including investigational therapies in trials being conducted by other sponsors.
In these circumstances, D3 Bio is willing to provide our investigational drug, D3S-001, for the treatment of eligible patients with KRASG12C-mutated advanced Colorectal cancer (CRC), in compliance with FDA’s Expanded Access (Compassionate Use) to investigational drugs regulations.
The purpose of this policy is to describe the requirements for Expanded Access to D3 Bio’s investigational products under the 21st Century Cures Act for the use of investigational drugs outside of clinical trial settings, when certain conditions are met.
This policy applies to provision of access to a D3 Bio’s investigational product that is not approved for any purpose in the country from which the request is intended to be used. This also includes the time period between regulatory approval of an investigational product and its commercial availability in a country. All expanded access programs must be conducted in agreement with applicable country-specific legal and regulatory requirements related to providing an investigational drug under expanded access.
D3 Bio believes that participation in one of our clinical trials is the best way to access our investigational drug. Whenever possible, D3 Bio’s investigational drug should be used as part of a clinical trial. Therefore, we encourage patients to speak with their physicians regarding participating in clinical trials. In rare cases where it is not feasible for patients with serious diseases to participate in clinical trials (e.g., patient ineligibility, lack of ongoing clinical trials, etc.) and have exhausted all available treatment options, D3 Bio will consider providing a requesting physician with pre-approval access to the investigational drug, for the treatment of an individual patient outside of a clinical trial, when following conditions are met.
Additional information about D3 Bio’s clinical trials is available on the NIH’s website by searching “D3 Bio” at www.clinicaltrials.gov.
D3 Bio shall reserve the right to revise the policy from time to time.
For EAP contact: