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

NCT06549751 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: MRKR-22-601-02
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreatic Cancer Metastatic; Pancreas Cancer; Pancreatic Cancer (Unresectable)

Outcome Measures

Primary Outcomes (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).

  Dose-limiting toxicities (DLTs)

  Through study completion. Approximately 24 months

Secondary Outcomes (2)

• 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

Other Outcomes (3)

• Exploratory: During Dose Escalation and Dose Expansion - evaluate the relationship between potential biomarkers and response

  Through study completion. Approximately 2.5 years

• Exploratory: During Dose Escalation and Dose Expansion - evaluate improvement in response rate with administration of MT-601

  Through study completion. Approximately 2.5 years

• During Dose Escalation and Dose Expansion evaluate survival rates

  through study completion - approximately 2.5 years

Study Arms (5)

Cohort 1 / MT-601 dose 400 million cells

EXPERIMENTAL

MT-601 dose 400 million cells

Drug: MT-601 dose 400 million cells

Cohort 3 / MT-601 1200 million cells

EXPERIMENTAL

MT-601 dose 1200 million cells

Drug: MT-601 dose 1200 million cells

Cohort 2 / MT-601 800 million cells

EXPERIMENTAL

MT-601 dose 800 million cells

Drug: MT-601 dose 800 million cells

Cohort -1 / MT-601 dose 200 million cells

EXPERIMENTAL

Experimental: Cohort -1 / MT-601 dose 200 million cells

Drug: MT-601 dose 200 million cells

Dose Expansion

EXPERIMENTAL

The Dose Expansion portion will begin after completion of the Dose Escalation portion with recommended dose of MT-601.

Drug: MT-601 dose 200 million cells; Drug: MT-601 dose 400 million cells; Drug: MT-601 dose 800 million cells; Drug: MT-601 dose 1200 million cells

Interventions

MT-601 dose 200 million cells DRUG

MT-601 Dose 200 million cells

Cohort -1 / MT-601 dose 200 million cells; Dose Expansion

MT-601 dose 400 million cells DRUG

MT-601 Dose 400 million cells

Cohort 1 / MT-601 dose 400 million cells; Dose Expansion

MT-601 dose 800 million cells DRUG

MT-601 Dose 800 million cells

Cohort 2 / MT-601 800 million cells; Dose Expansion

MT-601 dose 1200 million cells DRUG

MT-601 Dose 1200 million cells

Cohort 3 / MT-601 1200 million cells; Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Adequate pulmonary function with partial pressure of oxygen (pO2) on room air of at least 90%
• Adequate cardiac function with an ejection fraction ≥ 45%
• Adequate organ function, as defined below:
• 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

You may not qualify if:

• 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
• Known HIV
• Evidence of active hepatitis B as defined by:
• Positive hepatitis B surface antigen (HBsAg), or
• Negative HBsAg but a positive hepatitis B surface antibody (HBsAb) or positive hepatitis B core antibody (HBcAb) with a positive hepatitis B virus (HBV) DNA
• Evidence of active hepatitis C as defined by:
• a. Positive anti-hepatitis C virus antibody (HCVAb) with a positive hepatitis C virus (HCV) RNA by PCR
• Pregnant or currently breast-feeding

Sponsors & Collaborators

• Marker Therapeutics, Inc.: lead
• M.D. Anderson Cancer Center: collaborator

Study Sites (1)

The University of Texas MD Anderson

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Patricia Allison, BS

  Marker Therapeutics

  STUDY DIRECTOR

Central Study Contacts

Patricia Allison, BS

CONTACT

7174715205; pallison@markertherapeutics.com

Kaylor Hopkins

CONTACT

(817) 395-2275

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2024
• First Posted: August 12, 2024
• Study Start: July 16, 2026
• Primary Completion (Estimated): July 16, 2028
• Study Completion (Estimated): September 16, 2028
• Last Updated: May 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)