Participation in a clinical trial is generally the most appropriate way to access an investigational medicine. Clinical trials are designed to evaluate the safety and efficacy of new therapies and to generate the data required by regulatory authorities. Patients and healthcare providers are encouraged to review available clinical trials to determine whether participation may be an option.

At Adlai Nortye, we are committed to developing innovative therapies for patients with cancer and other serious diseases. We understand that some patients may seek access to investigational medicines outside of a clinical trial when no appropriate treatment options remain.

Our Approach

Access to investigation products outside of a clinical trial is referred to as expanded access. Adlai Nortye generally does not provide access to our early-stage investigational products outside of our clinical trials. This includes products in Phase 1 and Phase 2 clinical development.  In Phase I and 2 clinical development, safety, dosing, and early signs of efficacy are still being evaluated, available data may be limited, and, depending on the development program, drug supply may be limited; such that preserving the integrity of ongoing clinical trials remains important.

For late-stage products (i.e. post phase IIa), where registration trials have met primary safety and efficacy endpoints, petitions for expanded access will be accepted and reviewed.

For late-stage products, where primary endpoints may not have been met, formal direct patient access programs will not be established. In specific circumstances, where scientifically and ethically justified, Adlai Nortye may consider supporting investigator-initiated trials or compassionate use programs, provided that drug supply is available.

Expanded access requests may be considered only where permitted by applicable laws and regulations. Please note that investigational medicines have not yet been approved by regulatory authorities, and their risks and benefits may not be fully established. Patients and treating physicians should carefully consider the potential risks and possible benefits before requesting expanded access.

Adlai Nortye believes that participation in a clinical trial remains the most appropriate method for gaining access to our investigational therapies. These trials are essential for generating the data required by global regulatory authorities to assess the safety and efficacy of our products. Patients and healthcare providers interested in potential trial opportunities are encouraged to review clinical studies listed at (Clinical Study page).

Future Considerations

As our investigational programs advance and more clinical data become available, Adlai Nortye will continue to evaluate our position on expanded access. Any updates to this policy will be made available through our corporate website and in compliance with applicable regulations, including, but not limited to, the U.S. 21st Century Cures Act, relevant regulations in China, and those in other countries.

Patients or healthcare providers interested in the expanded access program should contact us through the contact link on the Adlai Nortye website at https://www.adlainortye.com/index.php/contact