Tulmimetostat for Skin Cancer

Recruiting at 1 trial location

Overseen By Neha Mehta-shah, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Washington University School of Medicine

Must not be taking: CYP3A inducers/inhibitors, Immunosuppressants

Disqualifiers: CNS lymphoma, Active infection, HIV, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Tulmimetostat (CPI-0209) for individuals with advanced skin conditions, specifically mycosis fungoides and Sézary syndrome. Researchers aim to determine if this medication is safe and effective for those who have not responded to other treatments. Participants will take the medication orally every day in cycles, with dosage varying based on the trial stage. This trial suits those diagnosed with mycosis fungoides or Sézary syndrome who have already undergone at least one other systemic treatment. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new medication.

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.

Is there any evidence suggesting that Tulmimetostat is likely to be safe for humans?

Research has shown that Tulmimetostat, also known as DZR123, is generally safe for use in certain cancer treatments. Previous studies found that most patients tolerated doses of 200 mg and 300 mg well, without severe side effects. Another study indicated that Tulmimetostat had a low rate of serious treatment-related side effects, making it a promising and safe option for some cancer treatments. However, this trial is in its early stages and primarily focuses on testing safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for skin cancer, which often include surgery, radiation, and chemotherapy, Tulmimetostat targets the cancer cells' genetic makeup directly. This innovative drug works by inhibiting specific enzymes that are crucial for cancer cell survival, potentially leading to fewer side effects compared to traditional therapies. Researchers are excited about Tulmimetostat because it is taken orally, making it more convenient for patients, and it has shown promise in targeting the cancer cells more precisely, which could improve treatment effectiveness and patient outcomes.

What evidence suggests that Tulmimetostat might be an effective treatment for skin cancer?

Research has shown that Tulmimetostat blocks certain proteins linked to cancer growth. In a study with patients who had various advanced cancers, Tulmimetostat shrank tumors after other treatments failed. Early results suggest it might be effective for skin cancers like mycosis fungoides (MF) and Sézary syndrome (SS) when other treatments have failed. This trial will evaluate different dosages of Tulmimetostat to determine its effectiveness and safety for advanced skin cancers. Although more research is needed, these findings suggest Tulmimetostat could be a promising option for people with advanced skin cancers. ^{1 2 6 7 8}

Who Is on the Research Team?

Neha Mehta-shah, M.D.

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

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

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

- Hemoglobin ≥ 8.0 g/dL, with or without transfusion

- Serum total bilirubin ≤ 1.5 x IULN

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Tulmimetostat

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.

How Is the Trial Designed?

Group I: Dose Expansion Cohort: Tulmimetostat (DZR123) - 300 mg Experimental Treatment 0 Interventions

Daily DZR123by 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 (DZR123) - 200 mg Experimental Treatment 0 Interventions

Daily DZR123 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 (DZR123) Experimental Treatment 0 Interventions

Daily DZR123 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+

Novartis

Industry Sponsor

Trials

1,646

Recruited

2,778,000+

Vasant Narasimhan

Novartis

Chief Executive Officer since 2018

MD from Harvard Medical School, Bachelor's in Biological Sciences from University of Chicago, Master's in Public Policy from John F. Kennedy School of Government

Shreeram Aradhye

Novartis

Chief Medical Officer since 2022

MD from Yale University, MSc in Clinical Epidemiology from University of Pennsylvania

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04104776

A Study of Tulmimetostat DZR123 (CPI-0209) in Patients ... The purpose of this open-label, first-in-human (FIH) trial is to evaluate the safety, tolerability, and preliminary clinical activity of Tulmimetostat as a ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.3094

EZH2/EZH1 inhibitor tulmimetostat (CPI-0209) in patients ... Results: As of Nov 08, 2022, 62 pts received ≥1 dose (safety evaluable); 48 had ≥1 postbaseline tumor assessment (efficacy evaluable). Pts had ...

3. withpower.com withpower.com/trial/phase-1-mycoses-8-2023-60527

Tulmimetostat for Skin Cancer · Recruiting Participants ... 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 ...

4. clinicaltrials.eu clinicaltrials.eu/trial/study-of-tulmimetostat-cpi-0209-for-patients-with-advanced-solid-tumors-and-lymphomas/

Study of Tulmimetostat (CPI-0209) for Patients with ... The purpose of this study is to determine the best dose of CPI-0209 and to evaluate its effectiveness in treating these advanced cancers. The ...

5. onclive.com onclive.com/view/fda-grants-fast-track-status-to-tulmimetostat-for-endometrial-cancer

FDA Grants Fast Track Status to Tulmimetostat ... - OncLive Moreover, 77.8% of patients had TEAEs that resulted in dose modifications, 38.3% had TEAEs that required dose reductions, and 70.4% had AEs ...

6. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.3102

Phase II dose optimization update with EZH2/EZH1 ... Tulmimetostat showed an improved and acceptable safety profile in OCCC and EC at 200 mg and 300 mg doses (versus 350 mg) with promising antitumor activity.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11781267/

Safety profile of EZH2 inhibitors for cancer - PubMed Central EZH2 inhibitors demonstrate a manageable safety profile with a low incidence of severe TRAEs, emphasizing their potential as safe therapeutic options in cancer ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05942300

CPI-0209 Plus Carboplatin in Patients With Platinum ... This study aims to investigate whether CPI-0209 will enhance ovarian cancer sensitivity to platinum-based chemotherapy and prolong the disease free interval ...