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

Conditions

• CTCL

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• PTX-100 — DRUG
  Peptidomimetic inhibitor of GGTase 1

Study Details

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.

Key Dates

Start date

Mar 28, 2025

Status verified

Jan 2026

Primary completion

Jan 31, 2028

Completion

Jun 30, 2028

Study Design

Enrollment

115 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Phase 2a PTX-100 500mg/m2
  Phase 2a PTX-100 will be 500mg/m2 IV infusion over 60 minutes on days 1 to 5 of a 14-day cycle for 4 cycles. This is then followed by IV infusion over 60 minutes on days 1 to 5 of a 21-day cycle for up to 18months.
• Experimental: Phase 2a PTX-100 1000mg/m2
  Phase 2a PTX-100 will be 1000mg/m2 IV infusion over 60 minutes on days 1 to 5 of a 14-day cycle for 4 cycles. This is then followed by IV infusion over 60 minutes on days 1 to 5 of a 21-day cycle for up to 18months.
• Experimental: Phase 2b PTX-100 Recommended Optimal Dose (ROD).
  Phase 2b PTX-100 will be the Recommended Optimal Dose form Phase 2a and follow the same infusion timeline outlined previously. IV infusion of RD over 60 minutes on days 1 to 5 of a 14-day cycle for 4 cycles then followed by IV infusion of RD over 60 minutes on days 1 to 5 of a 21-day cycle up to 18months.

Primary Outcome Measure

To determine the efficacy of PTX-100 as determined by ORR. [ Time Frame: 18 months from day of first treatment until disease progression, unacceptable toxicity, participant or Investigator decision. ]

Central Contacts

• Upaly Bahadure
  +61 3 9692 7222
  [email protected]
• David Wong
  [email protected]

Locations (6)

Find similar trials in Duarte, CA

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