BridgeMD
New treatment option for Pancreatic Ductal Adenocarcinoma
Official title PTM-101 in Pancreatic Ductal Adenocarcinoma (PDAC)
ClinicalTrials.gov ID: NCT06673017
What this study is testing
What is PTM-101?
PTM-101 is an investigational medicine, being studied as a potential treatment for pancreatic ductal adenocarcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Imaging consistent with primary borderline resectable or locally advanced PDAC. PDAC may be confirmed by histology/cytology either at study-mandated...
- Indicated for laparoscopy
- No prior therapy of any kind for PDAC
- Acceptable laboratory values
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2
You likely can't join if
- Active non-pancreatic cancer that currently requires treatment or is being treated; diagnosis of another malignancy within the past 2 years. This...
- Contraindications or allergies to paclitaxel, PLGA (poly(lactic-co-glycolic ) acid), or contraindications to implantation of PTM-101 or...
- 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...
- Inability to comply with activities and therapeutic interventions as outlined in the schedule of events
- Currently enrolled in another investigational drug or device trial
See the full eligibility 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, how well it works results or prevent the subject from study participation
- people 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. This criterion excludes a history of carcinoma in situ of the cervix...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Newport Beach, California, United States
- Detroit, Michigan, United States
- Lake Success, New York, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Newport Beach, California, United States; Detroit, Michigan, United States; Lake Success, New York, United States; Dallas, Texas, United States; Houston, Texas, United States; Seattle, Washington, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.