MT-601 Administered To Patients With Locally Advanced Unresectable or Metastatic Pancreatic Cancer (NCT06549751) | Clinical Trial Compass
Not Yet RecruitingPhase 1
MT-601 Administered To Patients With Locally Advanced Unresectable or Metastatic Pancreatic Cancer
United States38 participantsStarted 2026-07-16
Plain-language summary
The goal of this clinical trial is to assess safety and tolerability of escalating doses of MT-601 administered during the off week of chemotherapy regimen for patients with pancreatic cancer. The main question\[s\] it aims to answer are: safety and efficacy • overall response rate and duration of response. Participants will meet all applicable inclusion criteria prior to chemotherapy and must agree to provide apheresis material.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Informed Consent
. Age ≥ 18 years
. ECOG performance status of 0 to 1
. Cytologically or histologically confirmed, locally advanced, unresectable or metastatic pancreatic adenocarcinoma (pancreatic carcinomas with at least some component of adenocarcinoma included).
. Measurable or evaluable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
. Prior receipt of at least 4 doses (\~2 months) of FFX or NLX with plans for completion of 12 doses (\~6 months)
. Absence of progression during treatment with FFX or NLX (eg. CR, PR, or SD at study entry)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
During Dose Escalation - determine the MTD, recommended expansion dose, or MPD of MT-601 administered during maintenance capacitabine following treatment with FOLFIRINOX (FFX) or NALIRIFOX (NLX).
Timeframe: Through study completion. Approximately 24 months
. Adequate pulmonary function with partial pressure of oxygen (pO2) on room air of at least 90%
Exclusion criteria
. Known CNS metastases or meningeal carcinomatosis unless treated and controlled for ≥ 3 months prior to the first administration of MT-601 without the need for increasing doses of steroids
. Other known active cancer likely to require additional treatment in the next 2 years unless approved by Medical Monitor
. Active bacterial, viral, or fungal infection requiring systemic therapy. Patients may be re-evaluated for eligibility upon completion of infection treatment.
. Significant cardiovascular risk (eg, coronary stenting within 4 weeks, myocardial infarction within 6 months)
. Diagnosis of significant immunodeficiency that in the Investigator or Medical Monitor's judgment would preclude participation in the study.
. Administration of systemic steroid therapy (\> 10 mg/day of prednisone equivalent) ≤ 7 days prior to the first administration of MT-601
. Active autoimmune disease that required systemic treatment in the past 2 years (replacement therapies excluded \[eg, thyroxine, insulin, physiologic corticosteroids\])
. History of solid organ or hematologic transplant