PTM-101 in Pancreatic Ductal Adenocarcinoma (PDAC)

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)

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).

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Cancer; Pancreatic Ductal Adenocarcinoma; Locally Advanced Pancreatic Adenocarcinoma; Borderline Resectable Pancreatic Adenocarcinoma
• Intervention / Treatment: Drug: PTM-101

Detailed Description

This is a multi-center, non-randomized, single-arm, open-label, phase Ib dose escalation/dose expansion study of PTM-101 in subjects with pancreatic ductal adenocarcinoma (PDAC). Dose escalation will assess the safety of PTM-101 containing escalating doses of paclitaxel to establish the preliminary Recommended Phase II Dose (RP2D) when combined with neoadjuvant chemotherapy for subjects who are treatment-naïve, have borderline resectable or locally advanced PDAC and are eligible for neoadjuvant chemotherapy. Subsequently, the dose expansion portion will expand the number of subjects at the preliminary RP2D to assess the efficacy of PTM-101.

• Study Type: Interventional
• Enrollment (Estimated): 26
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Chelsea Reinhold; Phone Number: 2032419779; Email: ClinOps@panthertx.com

Study Locations

• United States
  • California
    • Newport Beach, California, United States, 92658
      • Recruiting
      • Hoag Memorial Hospital Presbyterian
      • Principal Investigator: Tara Seery, MD
      • Contact: Patrice Jones; Phone Number: 949-764-5501; Email: Patrice.Jones@hoag.org
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Recruiting
      • Karmanos Cancer Institute
      • Contact: Eliza Beal, MD; Phone Number: 800-KARMANOS; Email: beale@karmanos.org
      • Principal Investigator: Eliza Beal, MD
  • New York
    • Lake Success, New York, United States, 11042
      • Recruiting
      • Northwell Health Zuckerberg Cancer Center
      • Contact: Jenna Battaglia; Phone Number: 516-734-8812; Email: JBattaglia2@northwell.edu
      • Principal Investigator: Danielle Deperalta, MD
  • Texas
    • Dallas, Texas, United States, 75390
      • Recruiting
      • University of Texas Southwestern Medical Center
      • Contact: Emilia Callahan; Phone Number: 214-648-5870; Email: emilia.callahan@utsouthwestern.edu
      • Principal Investigator: Matthew Porembka, MD
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas MD Anderson Cancer Center
      • Contact: Ching-Wei Tzeng, MD; Phone Number: 713-792-0386; Email: cdtzeng@mdanderson.org
      • Principal Investigator: Ching-Wei Tzeng, MD
  • Washington
    • Seattle, Washington, United States, 98101
      • Recruiting
      • Virginia Mason Medical Center
      • Principal Investigator: Vincent Picozzi, MD
      • Contact: Colette Treperinas; Phone Number: 206-287-6286; Email: Colette.Treperinas@commonspirit.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Imaging consistent with primary borderline resectable or locally advanced PDAC. PDAC may be confirmed by histology/cytology either at study-mandated laparoscopy or by prior biopsy/cytology
• Indicated for laparoscopy
• No prior therapy of any kind for PDAC
• Acceptable laboratory values
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2
• Ability to provide informed consent
• No symptomatic 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

Exclusion Criteria:

• Active non-pancreatic cancer that currently requires treatment or is being treated; diagnosis of another malignancy within the past 2 years. This criterion excludes a history of carcinoma in situ of the cervix, superficial non-melanoma skin cancers, or superficial bladder cancer that has been adequately treated, or stage 1 prostate cancer that does not require treatment or requires only treatment with luteinizing hormone-releasing hormone agonists or antagonists if initiated at least 30 days prior to screening). Other potentially indolent cancers may be considered.
• Contraindications or allergies to paclitaxel, PLGA (poly(lactic-co-glycolic ) acid), or contraindications to implantation of PTM-101 or chemotherapies in protocol (e.g., FOLFIRINOX, gemcitabine, nab-paclitaxel)
• Known history of human immunodeficiency virus (HIV) or active viral hepatitis
• Active ongoing infection or autoimmune disease which may preclude laparoscopy, placement of PTM-101, administration of chemotherapy or surgical resection of pancreatic tumor
• Inability to comply with activities and therapeutic interventions as outlined in the schedule of events
• Currently enrolled in another investigational drug or device trial
• Women who are pregnant or breastfeeding or who plan to become pregnant or breastfeed; men who plan to donate sperm or conceive a child
• Any other medical or surgical conditions, including prior abdominal surgery, that would preclude safe laparoscopy or implantation in the opinion of the investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: PTM-101; PTM-101, an absorbable drug product containing paclitaxel
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.	Drug: PTM-101; PTM-101, an absorbable drug product containing paclitaxel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose Escalation	Number of subjects with PTM-101/PTM-101 placement-related adverse events as assessed by CTCAE v5.0	Within 21 days of PTM-101 placement

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose Expansion	Safety: serious adverse events related to PTM-101 or PTM-101 placement	Within 3 months of PTM-101 placement
Dose Expansion	Efficacy: volume response rate (VRR) of ≥ 40% reduction in tumor volume	Within 3 months of PTM-101 placement
Dose Escalation and Dose Expansion	Overall response rate (ORR) by RECIST 1.1 and WHO	At 21 days and 3 months post PTM-101 placement
Dose Escalation and Dose Expansion	Progression free survival (PFS) per RECIST 1.1	Within 24 months of PTM-101 placement
Dose Escalation and Dose Expansion	Overall survival (OS)	Within 24 months of PTM-101 placement

Collaborators and Investigators

• Sponsor: PanTher Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: October 31, 2024
• First Submitted That Met QC Criteria: November 1, 2024
• First Posted (Actual): November 4, 2024

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: PT-22-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No