PTM-101 for Pancreatic Cancer

Recruiting at 2 trial locations

Overseen By Tremaine Brown

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

Trial Summary

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.

What is the purpose of this trial?

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).

Eligibility Criteria

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

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.

* Acceptable laboratory values

Timeline

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

Treatment Details

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.

Participant Groups

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+