AdageneCares - Adagene

* Indicates required fields

Requesting Physician Details

Name:

First

Last

E-mail:

Phone Number:

Please include country and city code.

Institution & Address:

Clinical Trial Eligibility

Is the patient ineligible for active ADG126 clinical trials? FDA mandates this under 21 CFR 312.305(a)(2)

No (EA cannot be granted)
Yes (explain)

If you check Yes, please write an explanation below.

Explain:

Patient Information

Please do not enter any patient identifiable information (date of birth, etc.).

Patient Age:

Patient Sex:

Patient Medical History Summary:

Diagnosis:

Prior Therapies:

Pembrolizumab Access

Documentation attached?

Planned Printed Signature:

Source of pembrolizumab:

ADG126 Dosing Plan

The ADG126 is only available in USA ONLY. Your request will be verified and addressed promptly.

Planned dose and schedule:

Planned start date (estimate):

Administration site:

Monitoring plan:

Rationale for ADG126 Request

Details:

Please provide details of the treatment history and the rationale for why you believe ADG126 may be beneficial.

Treating Physician Certification

I certify that the patient has a serious or life-threatening condition, lacks satisfactory alternative therapies, and does not qualify for an appropriate clinical trial. I agree to obtain IRB approval as required, ensure appropriate informed consent, and comply with FDA safety reporting requirements.

Signature:

Date:

Printed Name:

ADG126 Expanded Access Request Form