PTM-101 in Pancreatic Ductal Adenocarcinoma (PDAC)

NCT06673017 | Recruiting Phase 1 FDA Drug

• 1 other identifier: PT-22-001
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 6

Brief 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).

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Dose Expansion

  Within 3 months of PTM-101 placement

• Dose Expansion

  Within 3 months of PTM-101 placement

• Dose Escalation and Dose Expansion

  At 21 days and 3 months post PTM-101 placement

• Dose Escalation and Dose Expansion

  Within 24 months of PTM-101 placement

• Dose Escalation and Dose Expansion

  Within 24 months of PTM-101 placement

Study Arms (2)

Dose Escalation

EXPERIMENTAL

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

Dose Expansion

EXPERIMENTAL

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

Interventions

PTM-101 DRUG

PTM-101, an absorbable drug product containing paclitaxel

Dose Escalation; Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• PanTher Therapeutics: lead

Study Sites (6)

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92658, United States

RECRUITING

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

RECRUITING

Northwell Health Zuckerberg Cancer Center

Lake Success, New York, 11042, United States

RECRUITING

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Central Study Contacts

Chelsea Reinhold

CONTACT

2032419779; ClinOps@panthertx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: November 4, 2024
• Study Start: April 14, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): June 1, 2028
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)