Pancreatic Ductal Adenocarcinoma (mPDAC)NCT07399015
Expanded Access to Mifomelatide for Cachexia in Adults With Advanced PDAC
A study testing mifomelatide in people with Pancreatic Ductal Adenocarcinoma (mPDAC) and Unresectable Pancreatic Ductal Adenocarcinoma, run by Endevica Bio.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma (mPDAC), Unresectable Pancreatic Ductal Adenocarcinoma, Metastatic PDAC
- What is being tested?
- mifomelatide
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
About this study
Official title: 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
Read the 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).
- Conditions
- Pancreatic Ductal Adenocarcinoma (mPDAC), Unresectable Pancreatic Ductal Adenocarcinoma, Metastatic PDAC
- Being tested
- mifomelatide
- Keywords
- cancer weight loss, advanced pancreatic cancer, metastatic pancreatic cancer, cancer cachexia, advanced pancreatic ductal adenocarcinoma, weight loss in pancreatic cancer
- Medical subject headings
- Anophthalmia with pulmonary hypoplasia, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mifomelatideDrug
Eligible participants will receive 25 mg mifomelatide daily by subcutaneous (SC) injection for up to 13 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Ductal Adenocarcinoma (mPDAC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Endevica Bio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Meghan Joly, PhD, Study director, Endevica Bio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07399015
- Sponsor's protocol ID
- Mifomelatide-EAP-01
- Status last verified
- Feb 2026
- First submitted
- 23 Jan 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermediate-size Expanded Access Protocol (EAP): Mifomelatide for the Treatment of Cachexia in Adults With Advanced, Unresectable PDAC
- ClinicalTrials.gov ID
- NCT07399015
- Acronym / sponsor ID
- Mifomelatide-EAP-01
- 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
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Endevica BioIndustry (pharma, biotech, devices)
- First posted
- 10 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
- Eastern Cooperative Oncology Group (ECOG) status of ≤ 3 and life expectancy ≥ 4 months
- Lack of satisfactory therapeutic alternatives for their cancer cachexia
Key exclusion criteria (12 listed)
- 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
- Currently pregnant, breastfeeding or planning to become pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mifomelatideEligible participants will receive 25 mg mifomelatide daily by subcutaneous (SC) injection for up to 13 weeks. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meghan Joly, PhD study director
Endevica Bio
Questions about this trial
What is this clinical trial studying?
A study testing mifomelatide in people with Pancreatic Ductal Adenocarcinoma (mPDAC) and Unresectable Pancreatic Ductal Adenocarcinoma, run by Endevica Bio.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.