Pancreatic Ductal AdenocarcinomaPhase 1NCT06673017
PTM-101 in Pancreatic Ductal Adenocarcinoma (PDAC)
A Phase 1 study testing PTM-101 in people with Pancreatic Ductal Adenocarcinoma and Borderline Resectable Pancreatic Adenocarcinoma, run by PanTher Therapeutics at 9 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma, Borderline Resectable Pancreatic Adenocarcinoma, Locally Advanced Pancreatic Adenocarcinoma
- What is being tested?
- PTM-101
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 14 Apr 2025to Jun 2028
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
9 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
9 sites in 2 countries
United States8 sites, 8 recruiting
- Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Emilia Callahan, 214-648-5870, emilia.callahan@utsouthwestern.edu
Matthew Porembka, MD
- Recruiting
Karmanos Cancer Institute
Detroit, Michigan, 48201
Eliza Beal, MD, 800-KARMANOS, beale@karmanos.org
Eliza Beal, MD
- Recruiting
Henry Ford Health System
Detroit, Michigan, 48202
David Kwon, MD, 313-556-8144, dkwon1@hfhs.org
David Kwon, MD
- Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Ching-Wei Tzeng, MD, 713-792-0386, cdtzeng@mdanderson.org
Ching-Wei Tzeng, MD
- Recruiting
Northwell Health Zuckerberg Cancer Center
Lake Success, New York, 11042
Gina Carrara, 516-734-8891, gcarrara@northwell.edu
Danielle Deperalta, MD
- Recruiting
University of Miami Sylvester Cancer Center
Miami, Florida, 33136
Caitlin Hester, MD, 305-243-4902, chester@miami.edu
Caitlin Hester, MD
- Recruiting
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92658
Rana Najjar, 949-764-5559, Rana.Najjar@Hoag.org
Ronald Wolf, MD
- Recruiting
Virginia Mason Medical Center
Seattle, Washington, 98101
Marie Hwang, 206-287-6280, Marie.Hwang@commonspirit.org
Vincent Picozzi, MD
Australia1 site, 1 recruiting
- Recruiting
The Alfred
Melbourne, Victoria, 3004
SA Antero Pe, 03 9076 7896, S.Pe@alfred.org.au
Charles Pilgrim, MD
About this study
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)
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).
Read the 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.
- Conditions
- Pancreatic Ductal Adenocarcinoma, Borderline Resectable Pancreatic Adenocarcinoma, Locally Advanced Pancreatic Adenocarcinoma, Pancreatic Cancer
- Being tested
- PTM-101
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTM-101Drug
PTM-101, an absorbable drug product containing paclitaxel
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: PTM-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Escalation
Number of subjects with PTM-101/PTM-101 placement-related adverse events as assessed by CTCAE v5.0
Measured: Within 21 days of PTM-101 placement
Secondary outcomes (5)
Dose Expansion
Safety: serious adverse events related to PTM-101 or PTM-101 placement
Measured: Within 3 months of PTM-101 placement
Dose Expansion
Efficacy: volume response rate (VRR) of ≥ 40% reduction in tumor volume
Measured: Within 3 months of PTM-101 placement
Dose Escalation and Dose Expansion
Overall response rate (ORR) by RECIST 1.1 and WHO
Measured: At 21 days and 3 months post PTM-101 placement
Dose Escalation and Dose Expansion
Progression free survival (PFS) per RECIST 1.1
Measured: Within 24 months of PTM-101 placement
Dose Escalation and Dose Expansion
Overall survival (OS)
Measured: Within 24 months of PTM-101 placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start14 Apr 2025
- Primary completionDec 2026 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model 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).
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PanTher Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06673017
- Sponsor's protocol ID
- PT-22-001
- Status last verified
- Oct 2026
- First submitted
- 31 Oct 2024
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No