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We are currently evaluating the safety and tolerability of RLY-1971 in a Phase 1 dose escalation study in patients with advanced or metastatic solid tumors.
In August 2021, Genentech initiated the cohort of RLY-1971/GDC-1971, an inhibitor of SHP2, in combination with GDC-6036, an inhibitor of KRAS G12C, in a Phase 1b trial.
We are currently evaluating the safety and tolerability of RLY-4008 in a first-in-human dose escalation study in patients who have FGFR2 alterations in advanced solid tumors.
For questions or interest in participating in our clinical trials, please email us.
Expanded Access Policy
Relay Therapeutics is hyper-focused on bringing life-changing medicines to patients. Our goal is to provide access to our investigational therapies when it is appropriate. Read on to learn more.
Expanded access, also called compassionate use, refers to the use of an investigational therapy outside a clinical trial when the primary purpose is to diagnose, prevent or treat a serious or immediately life-threatening condition in a patient. This is different from a clinical trial, where more comprehensive safety and efficacy data are collected. We understand the need for expanded access programs, and we recognize the importance of having an appropriate policy.
Several factors, consistent with the US Food and Drug Administration (US FDA) and other regulatory agencies’ guidelines should be taken into account when considering expanded access. They include:
- The illness must be serious or life-threatening with no other satisfactory treatment options (such as approved products or open clinical trials)
- There is sufficient evidence that the potential benefit to the patient would likely outweigh the potential risks, based on available safety and efficacy information
- The ability to provide a therapy in a fair and equitable manner, so that there is adequate manufacturing capacity to provide therapies across all ongoing clinical trials and expanded access programs
- Whether granting expanded access would potentially compromise the scientific validity of broader development programs, or interfere with or delay current clinical trials or regulatory filings designed to make the therapy available to many more patients
Given the early state of our development programs, we believe that participation in one of our clinical trials is the most appropriate way to access our investigational therapies. Therefore, we are not currently making our investigational products available through an expanded access program. If you have additional questions, please speak with your physician or contact firstname.lastname@example.org.
In line with the 21st Century Cures Act, Relay Therapeutics may revise this policy at any time. This website and policy will be updated with a hyperlink or other reference to the expanded access record on clinicaltrials.gov after such record becomes active.
We are constantly working with patients, their families, caregivers, and advocacy groups to learn about the challenges patients experience in their daily lives and how we can best support them from a therapeutic perspective and beyond.