PTM-101 In Pancreatic Ductal Adenocarcinoma (PDAC)

Study Overview

PTM-101 in 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).

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.

Pancreatic Ductal Adenocarcinoma
Borderline Resectable Pancreatic Adenocarcinoma
Locally Advanced Pancreatic Adenocarcinoma

DRUG: PTM-101

PT-22-001

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2024-10-31	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-07-08
First Submitted that Met QC Criteria 2024-11-01	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-07-11
First Posted (ACTUAL) 2024-11-04	Results First Posted N/A	Last Verified 2025-07

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Sequential

Masking:
None

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 prelimina	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 locall	DRUG: PTM-101 PTM-101, an absorbable drug product containing paclitaxel

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 prelimina

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 locall

DRUG: PTM-101

PTM-101, an absorbable drug product containing paclitaxel

Primary Outcome Measures	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	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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Chelsea Reinhold

Phone Number: 2032419779

Email: creinhold@panthertx.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

Active non-pancreatic cancer that currently requires treatment or is being treated; diagnosis of another malignancy within the past 2 years (excluding 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)
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 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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