Expanded Access to Mifomelatide for Cachexia in Adults With Advanced PDAC

NCT07399015 | Unknown

• 1 other identifier: Mifomelatide-EAP-01
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

An expanded access program (EAP) allows doctors to give medicine to seriously ill patients before it is approved by local regulatory agencies. The goal of this Expanded Access Protocol is to provide access to mifomelatide for eligible cachectic adult patients with advanced, unresectable pancreatic ductal adenocarcinoma (PDAC) who lack satisfactory therapeutic alternatives for their cancer cachexia and are not eligible for current mifomelatide clinical trials. A participant may receive mifomelatide under this EAP if:

• A licensed doctor submits a request,
• The participant is eligible
• The country allows the EAP

Conditions

Pancreatic Ductal Adenocarcinoma (mPDAC); Unresectable Pancreatic Ductal Adenocarcinoma; Metastatic PDAC

Keywords

cancer weight loss; advanced pancreatic cancer; metastatic pancreatic cancer; cancer cachexia; advanced pancreatic ductal adenocarcinoma; weight loss in pancreatic cancer

Interventions

mifomelatide DRUG

Eligible participants will receive 25 mg mifomelatide daily by subcutaneous (SC) injection for up to 13 weeks.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be at least 18 years of age
• Documented histologic or cytologic diagnosis of advanced, unresectable PDAC
• Current cachexia (documented in medical records) as defined by Fearon criteria based on at least one of the following three weight loss conditions in the 6 months prior to enrollment:
• Weight loss of at least 5%
• Weight loss of at least 2% together with a BMI \<20 kg/m2 and/or
• Weight loss of at least 2% together with sarcopenia
• Eastern Cooperative Oncology Group (ECOG) status of ≤ 3 and life expectancy ≥ 4 months
• Lack of satisfactory therapeutic alternatives for their cancer cachexia
• Willing and able to safely self-inject or be injected by a caregiver daily
• Not eligible to participate in ongoing clinical trials of the investigational drug
• Willing and able to sign informed consent

You may not qualify if:

• Patients with BMI \> 35
• Known hypersensitivity to mifomelatide or its formulation
• Significant medical conditions or illnesses that might increase the risk-benefit ratio of participating in this EAP as determined by the
• Treating Physician, which may include:
• Patients with swallowing abnormalities, malabsorption syndromes, severe short or inflammatory bowel syndromes, or other conditions that in the Treating Physician's opinion could impair food consumption or metabolism
• Receiving exclusive tube feeding or parenteral nutrition at the time of enrollment
• History of weight loss surgery including gastric stapling, or bypass
• ANC \< 1.5 x 109/L
• AST and/or ALT \> 3 x ULN (\> 5 x ULN in the presence of documented liver metastases)
• Total bilirubin \> 1.5 x ULN (\> 3 x ULN in the presence of documented Gilbert's Syndrome)
• Creatinine clearance calculated by Cockcroft and Gault equation \< 50 mL/min Uncontrolled diabetes defined as HbA1c \>7%
• Currently pregnant, breastfeeding or planning to become pregnant

Sponsors & Collaborators

• Endevica Bio: lead

MeSH Terms

Conditions

Anophthalmia with pulmonary hypoplasia; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Meghan Joly, PhD

  Endevica Bio

  STUDY DIRECTOR

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2026
• First Posted: February 10, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02