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PTM-101 for Borderline Resectable or Locally Advanced Pancreatic Cancer

This study is testing a new drug called PTM-101, which contains paclitaxel, for people with pancreatic ductal adenocarcinoma (PDAC) that is borderline resectable (meaning surgery might be possible) or locally advanced (meaning it has not spread far). You might be able to join if you are 18 or older, have not had previous treatment for PDAC, and meet certain health requirements. The main goal of this first part of the study is to find the safest dose of PTM-101 when given with standard chemotherapy. Later, the study will look at how well PTM-101 works. The study plans to enroll 26 participants.

Study design
This is an early-stage (Phase 1b), single-arm study, meaning all participants receive the same treatment, and it is open-label, so both you and your doctors will know what treatment you are receiving. It plans to enroll 26 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, dose escalation, is measured within 21 days of PTM-101 placement.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06673017

PTM-101 in Pancreatic Ductal Adenocarcinoma (PDAC)

Recruiting
PHASE1Ages 18+InterventionalTreatment
PanTher Therapeutics
~26 participants
Updated 2026-09-02 on ClinicalTrials.gov
What's tested:PTM-101

At a glance

Recruiting sites
8 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose Escalation
Measured over Within 21 days of PTM-101 placement

Conditions

Pancreatic Ductal Adenocarcinoma
Borderline Resectable Pancreatic Adenocarcinoma
Locally Advanced Pancreatic Adenocarcinoma
Pancreatic Cancer

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Pancreatic Ductal Adenocarcinoma

NCT06673017

Where you'd take part

This study runs at 8 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, Californiastudy coordinator listed

    Recruiting

  • Karmanos Cancer Institute

    Detroit, Michiganstudy coordinator listed

    Recruiting

  • Northwell Health Zuckerberg Cancer Center

    Lake Success, New Yorkstudy coordinator listed

    Recruiting

  • The Alfred

    Melbourne, Victoria, Australiastudy coordinator listed

    Recruiting

  • The University of Texas MD Anderson Cancer Center

    Houston, Texasstudy coordinator listed

    Recruiting

  • University of Miami Sylvester Cancer Center

    Miami, Floridastudy coordinator listed

    Recruiting

  • University of Texas Southwestern Medical Center

    Dallas, Texasstudy coordinator listed

    Recruiting

  • Virginia Mason Medical Center

    Seattle, Washingtonstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Chelsea Reinhold
[email protected]
2032419779
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Dose EscalationWithin 21 days of PTM-101 placement

    Number of subjects with PTM-101/PTM-101 placement-related adverse events as assessed by CTCAE v5.0