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: 30
• Locations: 0 countries
• Sites: N/A

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

Pancreas Cancer

Outcome Measures

Primary Outcomes (3)

• During Dose Escalation - assess the safety and tolerability of escalating doses of MT-601 administered during the off week of chemotherapy regimen.

  * Dose-limiting toxicities (DLTs) * Safety (including but not limited to): treatment-emergent adverse events, SAEs, deaths, and clinical laboratory abnormalities per NCI CTCAE, Version 5.0

  Through study completion. Approximately 3 years

• During Dose Expansion - estimate overall response rate (ORR) of MT-601

  To estimate overall response rate (ORR) of MT-601 administered during the off week of chemotherapy regimen (RECIST v1.1) ORR to be measured by disease assessments conducted prior to treatment, at baseline, 8 weeks, 16 weeks and during active follow-up visits which will occur every 8 weeks (starting from Week 24), using RECIST v1.1

  Through study completion. Approximately 3 years

• During Dose Expansion - estimate duration of response (DOR) of MT-601

  To estimate duration of response (DOR)of MT-601 administered during the off week of chemotherapy regimen (RECIST v1.1) DRR to be measured by disease assessments conducted prior to treatment, at baseline, 8 weeks, 16 weeks and during active follow-up visits which will occur every 8 weeks (starting from Week 24), using RECIST v1.1

  Through study completion. Approximately 3 years

Secondary Outcomes (2)

• During Dose Escalation and Dose Expansion - determine the Efficacy of MT-601

  Through study completion. Approximately 3 years

• During Dose Expansion - assess safety and tolerability of MT-601

  Through study completion. Approximately 3 years

Other Outcomes (2)

• Exploratory: During Dose Escalation and Dose Expansion - examine the expansion, persistence, clonality and anti-tumor immune effects of the adoptively transferred, autologous MT-601, as well as the presence of epitope spreading in all groups

  Through study completion. Approximately 3 years

• Exploratory: During Dose Escalation and Dose Expansion - assess anti-tumor activity of MT-601 administered during the off week of chemotherapy regimen based on iRECIST

  Through study completion. Approximately 3 years

Study Arms (2)

Escalation

EXPERIMENTAL

Cohort -1 / 100 million cells / 3-6 patients Cohort 1 / 200 million cells / 3-6 patients Cohort 1 / 400 million cells / 3-6 patients

Biological: MT-601

Expansion

EXPERIMENTAL

The Dose Expansion portion will begin after completion of the Dose Escalation portion and focus on the efficacy of MT-601 as add-on to front-line chemotherapy. The dose level for the expansion portion of the study will be selected based on totality of the data. The primary objective is to evaluate clinical efficacy for the dose expansion. A total of 20 to 25 patients are planned to be enrolled.

Biological: MT-601

Interventions

MT-601 BIOLOGICAL

Cellular Therapy

Escalation; Expansion

Eligibility Criteria

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

You may qualify if:

• Cytologically or histologically confirmed newly diagnosed locally advanced, unresectable or metastatic pancreatic adenocarcinoma (excluding other pancreatic malignancies such as acinar cell carcinomas or neuroendocrine cell neoplasms, etc.).
• Eligible for reassessment following 2 months of front-line chemotherapy (FOLFIRINOX or gemcitabine/nab-paclitaxel): Patient must have experienced a response of SD, PR, or CR per RECIST v1.1 after 2 months of front-line chemotherapy (FOLFIRINOX or gemcitabine/nab-paclitaxel).
• ≥18 years of age prior to administration of MT-601.
• Measurable or evaluable disease per RECIST v1.1 at the time of screening.
• Must have sufficient leukapheresis material to manufacture autologous MT601.
• Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale.
• Life expectancy ≥12 weeks.
• Pulse oximetry of \>90% on room air in patients with previous radiation therapy.
• Adequate organ function, as defined below:
• Absolute neutrophil count (ANC) ≥1.5 × 109/L
• Platelets ≥75 × 109/L
• Hemoglobin ≥9 g/dL (can be transfused)
• International normalized ratio (INR) or prothrombin time (PT) ≤1.5 × upper limit of normal (ULN) (unless patient receiving stable dose of anticoagulant therapy as long as PT or INR in therapeutic range of intended anticoagulant)
• Partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) PTT or aPTT ≤ 5 seconds above ULN (unless patient receiving stable dose of anticoagulant therapy "a" as long as PT or INR in therapeutic range of intended anticoagulant)
• Total bilirubin ≤2 × ULN

You may not qualify if:

• N/A

Sponsors & Collaborators

• Marker Therapeutics, Inc.: lead

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

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: September 1, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 12, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share