Recruiting
Phase 1

PTM-101

Sponsor:

PanTher Therapeutics

Code:

NCT06673017

Conditions

Pancreatic Ductal Adenocarcinoma

Borderline Resectable Pancreatic Adenocarcinoma

Locally Advanced Pancreatic Adenocarcinoma

Pancreatic Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PTM-101

Study Details

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 Ductal Adenocarcinoma

Borderline Resectable Pancreatic Adenocarcinoma

Locally Advanced Pancreatic Adenocarcinoma

Pancreatic Cancer

Study ID

NCT06673017

Start date

Apr 14, 2025

Status verified date

Sep, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

26 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

PTM-101

PTM-101, an absorbable drug product containing paclitaxel

Primary outcome measure

  • Dose Escalation [ Time Frame: Within 21 days of PTM-101 placement ]

Central Contacts and Locations

Central contacts

Chelsea Reinhold

2032419779ClinOps@panthertx.com

Locations

Hoag Memorial Hospital Presbyterian

Recruiting

Newport Beach, California, United States, 92658

Contacts

Rana Najjar

949-764-5559Rana.Najjar@Hoag.org

Principal Investigator:

Ronald Wolf, MD

University of Miami Sylvester Cancer Center

Recruiting

Miami, Florida, United States, 33136

Contacts

Caitlin Hester, MD

305-243-4902chester@miami.edu

Principal Investigator:

Caitlin Hester, MD

Karmanos Cancer Institute

Recruiting

Detroit, Michigan, United States, 48201

Contacts

Eliza Beal, MD

800-KARMANOSbeale@karmanos.org

Principal Investigator:

Eliza Beal, MD

Northwell Health Zuckerberg Cancer Center

Recruiting

Lake Success, New York, United States, 11042

Contacts

Gina Carrara

516-734-8891gcarrara@northwell.edu

Principal Investigator:

Danielle Deperalta, MD

University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Emilia Callahan

214-648-5870emilia.callahan@utsouthwestern.edu

Principal Investigator:

Matthew Porembka, MD

The University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Ching-Wei Tzeng, MD

713-792-0386cdtzeng@mdanderson.org

Principal Investigator:

Ching-Wei Tzeng, MD

Virginia Mason Medical Center

Recruiting

Seattle, Washington, United States, 98101

Contacts

Marie Hwang

206-287-6280Marie.Hwang@commonspirit.org

Principal Investigator:

Vincent Picozzi, MD

More Information

Sponsor

PanTher Therapeutics

Last update posted

Sep 2, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by PanTher Therapeutics on 2026-09-02.