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Recruiting NCT06673017

PTM-101 in Pancreatic Ductal Adenocarcinoma (PDAC)

Phase I Interventional Pancreatic Ductal Adenocarcinoma Borderline Resectable Pancreatic Adenocarcinoma Locally Advanced Pancreatic Adenocarcinoma Pancreatic Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PTM-101.
Who it may be relevant to
Registry conditions: Pancreatic Ductal Adenocarcinoma, Borderline Resectable Pancreatic Adenocarcinoma, Locally Advanced Pancreatic Adenocarcinoma, Pancreatic Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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)

Overview

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).

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.

Interventions

  • Drug PTM-101
    PTM-101, an absorbable drug product containing paclitaxel

Primary outcome measures

  • Dose Escalation [Time frame: Within 21 days of PTM-101 placement]
Secondary outcome measures (5)
  • Dose Expansion [Time frame: Within 3 months of PTM-101 placement]
  • Dose Expansion [Time frame: Within 3 months of PTM-101 placement]
  • Dose Escalation and Dose Expansion [Time frame: At 21 days and 3 months post PTM-101 placement]
  • Dose Escalation and Dose Expansion [Time frame: Within 24 months of PTM-101 placement]
  • Dose Escalation and Dose Expansion [Time frame: Within 24 months of PTM-101 placement]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 6 centers
  • Hoag Memorial Hospital Presbyterian — Newport Beach
  • Karmanos Cancer Institute — Detroit
  • Northwell Health Zuckerberg Cancer Center — Lake Success
  • University of Texas Southwestern Medical Center — Dallas
  • The University of Texas MD Anderson Cancer Center — Houston
  • Virginia Mason Medical Center — Seattle

Identifiers

NCT: NCT06673017 · PT-22-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗