Tulmimetostat for Skin Cancer

Overseen by Neha Mehta-shah, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Washington University School of Medicine

Must not be taking: CYP3A inducers/inhibitors, Immunosuppressants

Disqualifiers: CNS lymphoma, Active infection, HIV, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The hypotheses of this study are that single agent CPI-0209 will be safe and well tolerated in patients with advanced (stage IB-IVB) mycosis fungoides (MF)/Sézary syndrome (SS) who have had at least one prior systemic therapy, and that in these patients, CPI-0209 will demonstrate efficacy and be worth of further study.

Will I have to stop taking my current medications?

The trial requires a washout period (time without taking certain medications) for some treatments before starting the study drug. You may need to stop certain medications, especially if they are systemic therapies for mycosis fungoides/Sézary syndrome or strong CYP3A inducers or inhibitors. It's best to discuss your specific medications with the trial team.

Research Team

Neha Mehta-shah, M.D.

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

This trial is for adults with advanced mycosis fungoides or Sézary syndrome who have tried at least one systemic therapy. They should be relatively healthy, able to perform daily activities, and have adequate organ function and blood counts. Pregnant women can't participate, and participants must use contraception.

Inclusion Criteria

I have confirmed mycosis fungoides or Sézary syndrome, stages IB to IVB.

- Serum total bilirubin ≤ 1.5 x IULN

- Platelets ≥ 75 x 10^9/L, without platelet transfusion for at least 14 days

Exclusion Criteria

I have lymphoma in my central nervous system.

I have been treated with an EZH2 inhibitor before.

I had local radiation therapy at least 2 weeks ago.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily CPI-0209 by mouth for days 1-28 of each 28-day cycle. Dose will depend on dose level assignment.

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

36 months

Treatment Details

Interventions

• Tulmimetostat (Histone Methyltransferase Inhibitor)

Trial Overview The trial tests Tulmimetostat (CPI-0209) on patients with specific skin lymphomas to see if it's safe and effective after other treatments failed. It's given as a single agent, meaning no other drugs are combined in the treatment regimen.

Participant Groups

Group I: Dose Expansion Cohort: Tulmimetostat (CPI-0209) - 300 mg Experimental Treatment 1 Intervention

Daily CPI-0209 by mouth for days 1-28 of each 28-day cycle. Dose will be the maximum-tolerated dose found during the dose de-escalation cohort which was 300 mg.

Group II: Dose Expansion Cohort: Tulmimetostat (CPI-0209) - 200 mg Experimental Treatment 1 Intervention

Daily CPI-0209 by mouth for days 1-28 of each 28-day cycle. Dose will be 200 mg as the maximum tolerated dose of 300 mg found during the initial dose expansion cohort caused numerous dose reductions.

Group III: Dose De-Escalation Cohort: Tulmimetostat (CPI-0209) Experimental Treatment 1 Intervention

Daily CPI-0209 by mouth for days 1-28 of each 28-day cycle. Dose will depend on dose level assignment of 300 mg daily, 250 mg daily, or 200 mg daily.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Swim Across America

Collaborator

Trials

8

Recruited

290+

The Foundation for Barnes-Jewish Hospital

Collaborator

Trials

43

Recruited

6,600+

MorphoSys AG

Industry Sponsor

Trials

27

Recruited

6,600+

Daniel E. Corbin Jr. Lymphoma Fund

Collaborator

Trials

1

Recruited

40+

Swim Across America

Collaborator

Trials

11

Recruited

410+