PTM-101 in Pancreatic Ductal Adenocarcinoma (PDAC)

Part of paid clinical trials in Newport Beach, California.

Sponsor
PanTher Therapeutics
Study ID
NCT06673017
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PTM-101 — DRUG
    PTM-101, an absorbable drug product containing paclitaxel

Study Details

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).

Key Dates

Start date
Apr 14, 2025
Status verified
May 2026
Primary completion
Sep 30, 2026
Completion
Jun 30, 2028

Study Design

Enrollment
26 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Hoag Memorial Hospital PresbyterianNewport BeachCalifornia92658
Patrice Jones
[email protected]
949-764-5501
Tara Seery, MD (PRINCIPAL_INVESTIGATOR)
Karmanos Cancer InstituteDetroitMichigan48201
Eliza Beal, MD
[email protected]
800-KARMANOS
Eliza Beal, MD (PRINCIPAL_INVESTIGATOR)
Northwell Health Zuckerberg Cancer CenterLake SuccessNew York11042
Jenna Battaglia
[email protected]
516-734-8812
Danielle Deperalta, MD (PRINCIPAL_INVESTIGATOR)
University of Texas Southwestern Medical CenterDallasTexas75390
Emilia Callahan
[email protected]
214-648-5870
Matthew Porembka, MD (PRINCIPAL_INVESTIGATOR)
The University of Texas MD Anderson Cancer CenterHoustonTexas77030
Ching-Wei Tzeng, MD
[email protected]
713-792-0386
Ching-Wei Tzeng, MD (PRINCIPAL_INVESTIGATOR)
Virginia Mason Medical CenterSeattleWashington98101
Colette Treperinas
[email protected]
206-287-6286
Vincent Picozzi, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Newport Beach, CA

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
Hoag Memorial Hospital Presbyterian· Newport Beach, CAKarmanos Cancer Institute· Detroit, MINorthwell Health Zuckerberg Cancer Center· Lake Success, NYUniversity of Texas Southwestern Medical Center· Dallas, TXThe University of Texas MD Anderson Cancer Center· Houston, TXVirginia Mason Medical Center· Seattle, WA

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