ADG126 (muzastotug)
Expanded Access Policy for ADG126 (muzastotug)
Policy Summary
Adagene may consider requests for expanded access (compassionate use) to ADG126 from licensed treating physicians on a case-by-case basis. Expanded access will be provided only when all applicable criteria below are met and when providing access will not interfere with clinical development or regulatory review. Expanded access will be provided under the appropriate FDA regulatory mechanism (e.g., single-patient IND or protocol under an intermediate-size expanded access IND), determined in collaboration between the sponsor and the treating physician. ADG126 must be administered in combination with Pembrolizumab, but Adagene cannot provide Pembrolizumab as it is not owned by Adagene. Therefore, patients must secure Pembrolizumab access prior to consideration for ADG126 access.
Eligibility Criteria
Patient condition: The patient has a serious or life-threatening disease or condition for which ADG126 may have efficacy based on the mechanism of action, has no comparable or satisfactory alternative therapies available, and does not qualify for an ongoing clinical trial. Currently, microsatellite stable colorectal cancer (MSS CRC) is the only indication for which evidence of efficacy has been demonstrated in a sizable population.
Potential benefit: The potential benefit to the patient justifies the potential risks of treatment.
Product supply: Adagene’ s priority is to complete clinical trials necessary for regulatory approval to benefit the broader patient population. Expanded access may be paused or limited if necessary to protect clinical trial integrity or supply
Pembrolizumab combination: ADG126 must be administered in combination with Pembrolizumab (Keytruda), which is owned by Merck & Co. Adagene cannot provide Pembrolizumab. Patients must provide proof of access to Pembrolizumab for the duration of ADG126 treatment. Although Merck is not part of this EAP, it has a separate public access program <https://www.merckaccessprogram-keytruda.com/keytrudaqlex/hcp/enrollment.html> for those in need of Pembrolizumab.
Region: Patients must receive treatment within the United States.
Providing access will not compromise ongoing clinical trials or the ability to obtain marketing approval.
How to Request Expanded Access
Treating physicians should submit complete requests, including relevant medical information and a proposed treatment plan for each patient. The treating physician must comply with FDA requirements for safety reporting, including serious and unexpected adverse events, as applicable. Investigators must ensure adequate safety monitoring, including reporting of serious adverse events (SAEs) to FDA per 21 CFR 312.32 and to Adagene within 24 hours. A monitoring plan consistent with FDA expanded access IND requirements must be included in the request. Please send an email to ea-info@adagene.com
Each Patient request should include:
Patient medical history summary
Age and sex
Diagnosis
Prior therapies and concomitant medications
Rationale for requesting ADG126
Proposed monitoring plan
Treating physician’s contact details
The FDA and the Institutional Review Board (IRB) must be contacted as required. The sponsor will collaborate with the treating physician to facilitate FDA submissions as needed