Currently, GI Innovation has an investigational therapy available for consideration under single-patient expanded access:
• GI-102 (CD80-IL2v): for the treatment of patients with advanced, unresectable, or metastatic solid tumors. GI-102 was designated for fast track from FDA for advanced or metastatic melanoma who have been previously treated with immunotherapy.
Each request is evaluated with fairness and integrity, taking into account the patient’s medical condition, the strength of the available scientific evidence, and the potential impact on ongoing studies and regulatory objectives.
Our top priority when evaluating requests for expanded access is to ensure patient safety and to avoid exposing patients to unnecessary risk.
To that end, GI Innovation will consider an expanded access program, or a single-patient expanded access request, if all of the following criteria are met:
1. The qualifications of the physician, including experience with the therapy or expertise with the specific disease or condition and ability to administer and monitor the patient’s safety
2. The patient has a serious or life-threatening illness and fulfills objective clinical criteria demonstrating critical medical need.
3. There are no comparable or satisfactory alternative therapies approved and available to treat the disease or condition.
4. The patient is not eligible for, or unable to participate in, any ongoing GI Innovation clinical trial of the investigational product.
5. Expanded access is permitted under applicable laws and regulations.
6. The investigational medicine has sufficient evidence to support a preliminary assessment that the potential benefit to patient outweighs the potential risks.
Information about our clinical trials can be found on the Pipeline tab of this GI Innovation’s website and by using health authority websites, including ClinicalTrials.gov.
All questions and requests regarding GI Innovation’s expanded access or compassionate use programs should be submitted to by email: eap@gi-innovation.com. In the case of requests by treating physicians, the email should contain information sufficient for GI Innovation to evaluate the request consistent with this policy.
Expanded access or compassionate use may be discontinued at any time at the discretion of GI Innovation. The EAP policy may change from time to time without prior notice.
What is the anticipated length of time necessary to acknowledge receipt of a request?
We anticipate acknowledging receipt of messages sent to these email addresses within ten business days (Korea Standard Time, KST).