PTX-100 for Cutaneous T-Cell Lymphoma

Recruiting at 9 trial locations

Overseen ByDavid Wong

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Prescient Therapeutics, Ltd.

Must not be taking: CYP inhibitors, Immunomodulatory drugs

Disqualifiers: CNS involvement, Cardiovascular disease, Active infection, Other malignancy, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires a washout period of 2 weeks (or 4 weeks for monoclonal antibodies) since any prior anti-cancer therapy. If you are on strong inhibitors or inducers of certain enzymes, you must stop them for at least 14 days before starting the trial. It's best to discuss your current medications with the trial team to see if any adjustments are needed.

How is the drug PTX-100 different from other treatments for cutaneous T-cell lymphoma?

PTX-100 is unique because it is a targeted therapy, which means it is designed to specifically attack cancer cells while minimizing damage to normal cells, unlike many conventional treatments that affect both. This approach may offer a more effective and potentially less harmful option for patients with cutaneous T-cell lymphoma.¹ ² ³ ⁴ ⁵

Eligibility Criteria

This trial is for individuals with Cutaneous T-Cell Lymphoma (CTCL) that has come back or didn't respond to previous treatments. Specific details about who can join are not provided, but typically participants need to meet certain health standards and may be required to have a particular stage of disease.

Inclusion Criteria

Life expectancy of 3 months or greater

A WOCBP must have a negative serum pregnancy within 72 hours of the first dose of study treatment

My cancer is at least Stage Ib.

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Exclusion Criteria

Has a known psychiatric disorder that would interfere with compliance with the requirements of the study

A history or current evidence of any condition, laboratory abnormality or other circumstance that might confound the results of the study or interfere with patient participation for the full duration of the study

Is a consumer of illicit or recreational drugs or has a recent history (within the last year) of drug or alcohol abuse or dependence that in the judgment of the Investigator, would interfere with compliance with the requirements of the study

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Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Treatment

PTX-100 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

18 months

Multiple visits per cycle for infusion and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

18 months

Treatment Details

Interventions

PTX-100

Trial OverviewThe study tests PTX-100 at two different doses (500 or 1000 mg/m2) given through an IV over an hour on the first five days of a cycle. Initially, cycles are 14 days each for four cycles, then extend to 21-day cycles. Participants will be observed or continue treatment up to 18 months.

Participant Groups

3Treatment groups

Experimental Treatment

Group I: Phase 2b PTX-100 Recommended Optimal Dose (ROD).Experimental Treatment1 Intervention

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.

Group II: Phase 2a PTX-100 500mg/m2Experimental Treatment1 Intervention

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.

Group III: Phase 2a PTX-100 1000mg/m2Experimental Treatment1 Intervention

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.