BridgeMD
New treatment option for CTCL
Official title A Phase 2 Study of PTX 100 in Patients With Relapsed/Refractory CTCL
ClinicalTrials.gov ID: NCT06854653
What this study is testing
What is PTX-100?
PTX-100 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for ctcl.
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 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 18 months
- 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
- Adult patient ≥18 years of age at the time of signing the informed consent.
- Patient is capable of giving adequate signed informed consent
- Have a confirmed diagnosis of CTCL with histological confirmation
- Patients must have greater than or equal to Stage Ib disease.
- Has received and failed (or intolerant of) at least 2 prior lines of prior systemic therapy for their disease.
You likely can't join if
- Patients with known central nervous system involvement.
- Patients who require the use of strong inhibitors or inducers of CYP enzymes or transporters (e.g., CYP3A4, 2D6, 2C19) or (P-gp, BCRP, OATP1B1...
- Significant cardiovascular disease. A history of, or concurrent interstitial lung disease or severely impaired lung function. 5\. Active viral...
See the full eligibility criteria
- Adult patient ≥18 years of age at the time of signing the informed consent.
- Patient is capable of giving adequate signed informed consent
- Have a confirmed diagnosis of CTCL with histological confirmation
- Patients must have greater than or equal to Stage Ib disease.
- Has received and failed (or intolerant of) at least 2 prior lines of prior systemic therapy for their disease.
- Has measurable disease defined by at least one of the following, within 28 days prior to start of study treatment: by evaluable by mSWAT or quantifiable by flow cytometry or morphology in blood or measurable by Lugano...
- On a stable dose of systemic corticosteroid (\< 10 mg prednisone or equivalent) are permitted. Participants on a stable dose of topical corticosteroids are permitted.
- Washout period- must be 2 weeks (4 weeks for monoclonal antibodies) or 5 -half-lives (whichever is longer) since any prior anti-cancer therapy.
- Must be human T-cell lymphotropic virus type 1 (HTLV1) negative.
- Has an ECOG PS of 0 to 2.
- Life expectancy of 3 months or greater
- Has adequate bone marrow function.
- Has adequate hepatic function.
- Has adequate Renal function.
- Has adequate coagulation function.
- Patients with Human Immunodeficiency virus (HIV) must be on established and stable effective anti-retroviral therapy for at least 4 weeks and have an HIV viral load of less than 400 copies/mL.
- Male patients are eligible to participate if they agree to use a highly effective contraception during the treatment period and for at least 3 months after the last dose of study treatment and refrain from donating...
- Female patients are eligible to participate if they are not pregnant, not breastfeeding, and at least one of the following conditions applies: -Not a woman of childbearing potential (WOCBP).
- A WOCBP who agrees to use a contraceptive method that is highly effective (with a failure rate of \< 1% per year) or be abstinent from heterosexual intercourse as their preferred method and usual lifestyle, beginning...
- A WOCBP must have a negative serum pregnancy within 72 hours of the first dose of study treatment.
- Must be willing and able to adhere to the study as judged by the Investigator.
- Patients with known central nervous system involvement.
- Patients who require the use of strong inhibitors or inducers of CYP enzymes or transporters (e.g., CYP3A4, 2D6, 2C19) or (P-gp, BCRP, OATP1B1, OATP1B3, OAT1. OAT3, OCT2, MATE1 and MATE2-K). Patients who are receiving...
- Significant cardiovascular disease. A history of, or concurrent interstitial lung disease or severely impaired lung function. 5\. Active viral, bacterial, fungal infection or other serious infection requiring ongoing...
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Irvine, California, United States
- New Haven, Connecticut, United States
- Boston, Massachusetts, United States
- Rochester, New York, United States
- Richmond, Virginia, United States
- Westmead, New South Wales, Australia
- Melbourne, Victoria, Australia
- Nedlands, Western Australia, Australia
- Bordeaux, Bordeaux, France
- Lyon, Pierre-Benite, France
- Paris, Île-de-France Region, France
- Bologna, Bologna, Italy
- Brescia, Brescia, Italy
- Milan, Milano, Italy
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 study runs about 18 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you 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 Duarte, California, United States; Irvine, California, United States; New Haven, Connecticut, United States; Boston, Massachusetts, United States; Rochester, New York, United States; Richmond, Virginia, United States and 9 more location(s). 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.