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MT-601 for Locally Advanced or Metastatic Pancreatic Cancer

This study is testing a new treatment called MT-601 for people with pancreatic cancer that has spread or cannot be removed by surgery. Researchers want to find out the safest and most effective dose of MT-601 when given during a break from chemotherapy (like FOLFIRINOX or NALIRIFOX) and while you are receiving maintenance capecitabine. The study will look at how safe MT-601 is, how well it works to shrink tumors, and how long those effects last. You may be able to join if you are at least 18 years old, have a good performance status (meaning you can perform daily activities), and have pancreatic adenocarcinoma that is measurable.

Study design
This study will enroll 38 participants and uses a modified 3+3 design to find the right dose of MT-601. It will then expand to further test the chosen dose.
What's involved
MT-601 will be given as a single intravenous (into a vein) dose after you finish your initial chemotherapy and have started maintenance capecitabine. You will also need to provide apheresis material (a blood donation where certain cells are collected).
Compensation
Not stated in the trial record.
Follow-up
The study will follow participants through study completion, which is approximately 24 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06549751

MT-601 Administered To Patients With Locally Advanced Unresectable or Metastatic Pancreatic Cancer

Not Yet Recruiting
PHASE1Ages 18+InterventionalTreatment
Marker Therapeutics, Inc.
~38 participants
Updated 2026-05-13 on ClinicalTrials.gov
What's tested:MT-601 dose 200 million cellsMT-601 dose 400 million cellsMT-601 dose 800 million cellsMT-601 dose 1200 million cells

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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).
Measured over Through study completion. Approximately 24 months

Conditions

Pancreas Cancer
Pancreatic Cancer Metastatic
Pancreatic Cancer (Unresectable)

Explore related trials

Pancreatic Carcinoma

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Patricia Allison, BS · STUDY_DIRECTOR · Marker Therapeutics

Who to contact

Patricia Allison, BS
[email protected]
7174715205
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Absolute neutrophil count (ANC) ≥1.0 × 109/L (growth factor support allowed)
Platelets ≥75,000/mm3 (supportive medications allowed)
Hemoglobin ≥9 gm/dL (transfusion allowed)
Total bilirubin ≤2.0 × ULN unless considered due to Gilbert's syndrome in which case, ≤ 3.0 x ULN
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 × ULN OR ≤5 × ULN if known tumor involvement of liver
Serum creatinine ≤2 × ULN OR estimated glomerular filtration rate (using institutional standard) ≥50 mL/min 11. Willingness to use adequate contraception throughout study and for a period of 3 months after last dose of any study drugs

What this trial measures

  • 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).Through study completion. Approximately 24 months

    Dose-limiting toxicities (DLTs)