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RECRUITING
NCT06854653
PHASE2

A Phase 2 Study of PTX 100 in Patients With Relapsed/Refractory CTCL

Sponsor: Prescient Therapeutics, Ltd.

View on ClinicalTrials.gov

Summary

This is an open-label, phase 2 randomized study to evaluate the efficacy, safety, pharmacokinetics (PK) and pharmadynamics (PD), of PTX-100 monotherapy at 500 or 1000 mg/m2 in patients with relapsed/refractory Cutaneous T-Cell Lymphoma (CTCL). PTX-100 will be administered by IV infusion over 60 minutes on days 1 to 5 of a 14-day cycle for 4 cycles, then 21 day cycle thereafter. Subjects will be treated or followed up, if subjects discontinue treatment, for up to 18 months.

Official title: An Open-Label, Phase 2 Study of PTX-100 Monotherapy in Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

115

Start Date

2025-03-28

Completion Date

2028-06

Last Updated

2026-03-31

Healthy Volunteers

No

Conditions

Interventions

DRUG

PTX-100

Peptidomimetic inhibitor of GGTase 1

Locations (15)

City of Hope Comprehensive Cancer Cente

Duarte, California, United States

University of California Irvine

Irvine, California, United States

Yale Cancer Center

New Haven, Connecticut, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Rochester Skin Lymphoma Medical Group. PLLC

Rochester, New York, United States

Virginia Commonwealth University Massey Comprehensive Cancer Cente

Richmond, Virginia, United States

Westmead Hospital

Westmead, New South Wales, Australia

Epworth Healthcare

Melbourne, Victoria, Australia

Linear Clinical Research

Nedlands, Western Australia, Australia

CHU de Bordeaux - Hopital Saint André

Bordeaux, Bordeaux, France

Hopital Lyon Sud

Lyon, Pierre-Benite, France

Hopital Saint Louis

Paris, Île-de-France Region, France

IRCCS Azienda Ospedaliero Universitaria di Bologna - Policlinico S. Orsola-Malpighi

Bologna, Bologna, Italy

Universita degli Studi Di Brescia-Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Brescia, Brescia, Italy

Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario San Raffaele)

Milan, Milano, Italy