A Phase Ib Dose Escalation/Dose Expansion Study of PTM-101 as an Adjunct to Neoadjuvant Therapy for Treatment Naïve, Borderline Resectable and Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC)
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
This is a multi-center, non-randomized, single-arm, open-label, phase Ib, dose escalation/dose expansion study of PTM-101 when combined with neoadjuvant chemotherapy for the treatment of treatment-naïve subjects with borderline resectable and locally advanced pancreatic ductal adenocarcinoma (PDAC).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Imaging consistent with primary PDAC (if PDAC is to be confirmed at study-mandated laparoscopy) or imaging consistent with primary PDAC with prior biopsy/cytology
• No radiographic or physical exam evidence of metastatic disease
• No prior chemo-, radio-, or surgical therapy for PDAC
• Acceptable laboratory values
• CA 19-9 \<500 U/mL at baseline after biliary decompression
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Ability to provide informed consent
• No signs or symptoms of pancreatitis
• No other active medical issues which would confound interpretation of safety monitoring, efficacy results or prevent the subject from study participation
• Subjects with childbearing potential must agree to use adequate contraception throughout study participation
Locations
United States
California
Hoag Memorial Hospital Presbyterian
RECRUITING
Newport Beach
Michigan
Karmanos Cancer Institute
RECRUITING
Detroit
New York
Northwell Health Zuckerberg Cancer Center
RECRUITING
Lake Success
Texas
The University of Texas MD Anderson Cancer Center
RECRUITING
Houston
Washington
Virginia Mason Medical Center
RECRUITING
Seattle
Contact Information
Primary
Chelsea Reinhold
ClinOps@panthertx.com
2032419779
Time Frame
Start Date:2025-04-14
Estimated Completion Date:2028-06
Participants
Target number of participants:26
Treatments
Experimental: Dose Escalation
Dose escalation will follow a modified (3+3) design to establish the preliminary RP2D and characterize the safety and pharmacokinetic profile of PTM-101, which will be taken together with all prior clinical data to establish and characterize the preliminary RP2D. A maximum of 12 subjects with treatment-naïve, borderline resectable or locally advanced PDAC will be recruited and receive PTM-101 combined with standard of care neoadjuvant chemotherapy, and be followed for a minimum of 24 months.
Experimental: Dose Expansion
The dose of PTM-101 will be the preliminary RP2D determined from all available clinical data. Up to 20 subjects, inclusive of those already assigned to the preliminary RP2D in the dose escalation part, with treatment-naïve, borderline resectable or locally advanced PDAC will be recruited and receive PTM-101, combined with standard of care neoadjuvant chemotherapy, and be followed for a minimum of 24 months.