A Phase 2 Study of PTX 100 in Patients With Relapsed/Refractory CTCL (NCT06854653) | Clinical Trial Compass
RecruitingPhase 2
A Phase 2 Study of PTX 100 in Patients With Relapsed/Refractory CTCL
United States115 participantsStarted 2025-03-28
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion 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 Criteria.
✓. 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.
Exclusion criteria
✕. 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 these medications at Screening can be enrolled into the trial if they discontinue them for at least 14 days or 5 half-lives, whichever is longer, before they commence PTX-100. An alternative pharmacological treatment should be instituted by the treating clinician based on clinical judgement.
What they're measuring
1
To determine the efficacy of PTX-100 as determined by ORR.
Timeframe: 18 months from day of first treatment until disease progression, unacceptable toxicity, participant or Investigator decision.