Expanded Access to Mifomelatide for Cachexia in Adults With Advanced PDAC

February 16, 2026 updated by: Endevica Bio

Intermediate-size Expanded Access Protocol (EAP): Mifomelatide for the Treatment of Cachexia in Adults With Advanced, Unresectable PDAC

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

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Detailed Description

This is an expanded access program (EAP) providing access to mifomelatide for participants with advanced, unresectable pancreatic ductal adenocarcinoma (PDAC) and cachexia, prior to approval by local regulatory agencies.

Availability of the EAP is dependent upon physician request, country eligibility and local/country regulations. Physicians may request access to the EAP for participants who they feel may benefit from mifomelatide and meet the eligibility criteria.

Once enrolled, participants will receive mifomelatide by subcutaneous injection once daily for up to 13 weeks.

Participants will be asked to follow the standard of care treatment for their cancer as outlined by their treating physician. Participants will be followed for safety up to 30 days after their final treatment. Physicians will be required to report safety data to Kalohexis (a spin off company from Endevica Bio).

Study Type

Expanded Access

Expanded Access Type

  • Intermediate-size Population

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Description

Inclusion Criteria:

  1. Must be at least 18 years of age
  2. Documented histologic or cytologic diagnosis of advanced, unresectable PDAC

  3. 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:

    1. Weight loss of at least 5%
    2. Weight loss of at least 2% together with a BMI <20 kg/m2 and/or
    3. Weight loss of at least 2% together with sarcopenia
  4. Eastern Cooperative Oncology Group (ECOG) status of ≤ 3 and life expectancy ≥ 4 months
  5. Lack of satisfactory therapeutic alternatives for their cancer cachexia
  6. Willing and able to safely self-inject or be injected by a caregiver daily
  7. Not eligible to participate in ongoing clinical trials of the investigational drug
  8. Willing and able to sign informed consent

Exclusion Criteria:

  1. Patients with BMI > 35
  2. Known hypersensitivity to mifomelatide or its formulation

  3. 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%
  4. Currently pregnant, breastfeeding or planning to become pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Endevica Bio

Collaborators

Kalohexis

Investigators

  • Study Director: Meghan Joly, PhD, Endevica Bio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

January 23, 2026

First Submitted That Met QC Criteria

February 2, 2026

First Posted (Actual)

February 10, 2026

Study Record Updates

Last Update Posted (Actual)

February 18, 2026

Last Update Submitted That Met QC Criteria

February 16, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mifomelatide-EAP-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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