PTM-101 for Pancreatic Cancer

Recruiting at 4 trial locations

Overseen By Chelsea Reinhold

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: PanTher Therapeutics

Must not be taking: Paclitaxel, FOLFIRINOX, Gemcitabine, others

Disqualifiers: Active cancer, HIV, Hepatitis, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

26 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called PTM-101 for individuals with a specific type of pancreatic cancer that hasn't spread and remains untreated. The study evaluates the safety of PTM-101 when combined with standard chemotherapy. Eligible participants must have imaging-confirmed pancreatic cancer, no prior cancer treatments, and no signs of cancer spreading. Participants should also be free of other active health issues or infections that could interfere with the study. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the PTM-101 trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that PTM-101 is likely to be safe for humans?

Research has shown that PTM-101 has been studied for its safety in treating pancreatic cancer. In earlier studies, PTM-101 was tested in patients with pancreatic ductal adenocarcinoma (PDAC) to determine the appropriate dose and assess patient tolerance. The results indicated that PTM-101 was safe at the tested doses, with most patients managing the treatment well.

In one study, the first group of patients received PTM-101 along with standard chemotherapy, and it was generally well-tolerated. No unexpected safety issues arose, meaning that while side effects can occur, they were mostly anticipated based on the medication's mechanism and similar treatments.

This ongoing research helps ensure that PTM-101 can be used safely in more patients. For those considering joining a trial, this information suggests that PTM-101 has been manageable for patients in the past. However, it is essential to consult a healthcare provider to understand what this might mean personally. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for pancreatic cancer, which typically involve chemotherapy drugs like gemcitabine and FOLFIRINOX, PTM-101 is unique because it offers a novel approach through a potentially new mechanism of action. Researchers are excited about PTM-101 because it is designed to be combined with standard neoadjuvant chemotherapy, potentially enhancing its effectiveness against treatment-naïve, borderline resectable, or locally advanced pancreatic ductal adenocarcinoma (PDAC). This combination aims to improve the overall safety and pharmacokinetic profile, possibly leading to better outcomes for patients. The study also seeks to establish a recommended phase 2 dose, which could pave the way for more effective treatment regimens in the future.

What evidence suggests that PTM-101 might be an effective treatment for pancreatic cancer?

Research shows that PTM-101 might deliver drugs more effectively to tumors in pancreatic cancer. In earlier animal studies, PTM-101 allowed more chemotherapy to reach the tumor compared to traditional methods. Early results from human studies indicate that PTM-101 can be safely placed in the body and might shrink tumors without causing the usual side effects of chemotherapy. In this trial, participants will receive PTM-101 combined with standard-of-care neoadjuvant chemotherapy. These initial findings are encouraging, suggesting PTM-101 could be useful in treating pancreatic ductal adenocarcinoma (PDAC). However, more research is needed to confirm these results. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with a specific type of pancreatic cancer (PDAC) that hasn't spread and who haven't had previous treatments. They should have no signs of pancreatitis, be in good physical condition (ECOG 0 or 1), have certain lab values within range, and not be dealing with other medical issues that could affect the study.

Inclusion Criteria

* Acceptable laboratory values

My scans show signs of pancreatic cancer, confirmed by biopsy.

My cancer has not spread to other parts of my body as shown by scans or physical exams.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Dose escalation to establish the preliminary Recommended Phase II Dose (RP2D) and assess safety and pharmacokinetics of PTM-101 with neoadjuvant chemotherapy

3 months

Regular visits as per protocol

Dose Expansion

Expansion to assess the efficacy of PTM-101 at the preliminary RP2D with neoadjuvant chemotherapy

3 months

Regular visits as per protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

What Are the Treatments Tested in This Trial?

Interventions

• PTM-101

Trial Overview The trial is testing PTM-101 combined with standard chemotherapy in patients with PDAC that's borderline resectable or locally advanced. It's an early-phase study to figure out the right dose and see how well it works when given before any potential surgery.

How Is the Trial Designed?

Group I: Dose Expansion Experimental Treatment 1 Intervention

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.

Group II: Dose Escalation Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

PanTher Therapeutics

Lead Sponsor

Trials

1

Recruited

30+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06673017

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 in subjects with pancreatic ductal ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.4_suppl.TPS775

Phase I study of PTM-101 as neoadjuvant therapy for ... This Phase I trial will assess the addition of PTM-101 prior to mFOLFIRINOX in 6 subjects with newly diagnosed borderline resectable or locally advanced PDAC.

3. asco.org asco.org/abstracts-presentations/ABSTRACT393742

Phase I study of PTM-101 as neoadjuvant therapy for ... Preclinical animal studies demonstrate that PTM-101 results in enhanced drug levels in the tumor compared with comparable systemic paclitaxel dosing leading ...

4. panthertx.com panthertx.com/wp-content/uploads/2024/04/PanTher-AACR-Poster-9505-Final.pdf

First in Human Phase 1 Study of Paclitaxel-Eluting PTM- ... Improvements in the treatment of pancreatic cancer have been very limited, in part due to the inability to deliver chemotherapy to the tumor at efficacious.

5. aacrjournals.org aacrjournals.org/cancerres/article/84/7_Supplement/CT106/742393/Abstract-CT106-First-in-human-phase-1-study-of

Abstract CT106: First-in-human phase 1 study of paclitaxel ... This study demonstrated that a PTM-101 implant was surgically feasible, safe, resulted in no systemic paclitaxel exposure, and caused a tumor size reduction in ...

6. biospace.com biospace.com/press-releases/panther-completes-first-cohort-in-pancreatic-cancer-phase-1b-trial-ahead-of-expectations

PanTher Completes First Cohort in Pancreatic Cancer ... The ongoing dose escalation and expansion study builds on findings from PanTher's first-in-human trial that confirmed the safety of PTM-101 at ...

7. targetedonc.com targetedonc.com/view/fda-clears-ind-application-of-novel-paclitaxel-administration-in-pancreatic-cancer

FDA Clears IND Application of Novel Paclitaxel ... A phase 1b study will investigate PTM-101, a directed administration of paclitaxel, in patients with nonmetastatic pancreatic cancer.