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MT-601 dose 200 million cells

Phase 1

Pancreas Cancer | Small molecule | Oncology |Marker Therapeutics, Inc.|Last Updated: May 13, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment38
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06549751MT-601 Administered To Patients With Locally Advanced Unresectable or Metastatic Pancreatic CancerPHASE1 NOT YET_RECRUITING 38 — — Jul 16, 2026Sep 16, 2028May 13, 20261 United States
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Study Endpoints
Primary Endpoints
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)

Secondary Endpoints
During Dose Expansion - evaluate the safety profile of MT-601
Through study completion. Approximately 2.5 years
During Dose Escalation and Dose Expansion - determine the Efficacy of MT-601
Through study completion. Approximately 2.5 years
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort 1 / MT-601 dose 400 million cellsEXPERIMENTALMT-601 dose 400 million cells
Cohort 3 / MT-601 1200 million cellsEXPERIMENTALMT-601 dose 1200 million cells
Cohort 2 / MT-601 800 million cellsEXPERIMENTALMT-601 dose 800 million cells
Cohort -1 / MT-601 dose 200 million cellsEXPERIMENTALExperimental: Cohort -1 / MT-601 dose 200 million cells
Dose ExpansionEXPERIMENTALThe Dose Expansion portion will begin after completion of the Dose Escalation portion with recommended dose of MT-601.
Interventions
NameTypeDescription
MT-601 dose 200 million cellsDRUGMT-601 Dose 200 million cells
MT-601 dose 400 million cellsDRUGMT-601 Dose 400 million cells
MT-601 dose 800 million cellsDRUGMT-601 Dose 800 million cells
MT-601 dose 1200 million cellsDRUGMT-601 Dose 1200 million cells
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Informed Consent 2. Age ≥ 18 years 3. ECOG performance status of 0 to 1 4. Cytologically or histologically confirmed, locally advanced, unresectable or metastatic pancreatic adenocarcinoma (pancreatic carcinomas with at least some component of adenocarcinoma included). 5. Mea...

Countries:United States
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT06549751Enrollment: 30 → 38
LOWMay 24, 2026NCT06549751studyFirstPostDate: changed