Phase I Study With an Expansion Cohort of Tulmimetostat (DZR123) in Patients With Mycosis Fungoides and Sézary Syndrome

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

The hypotheses of this study are that single agent DZR123 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, DZR123 will demonstrate efficacy and be worth of further study.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Histologically or cytologically confirmed mycosis fungoides or Sézary syndrome, stages IB to IVB with measurable disease and/or detectable blood involvement based on the Global Response Criteria for CTCL (Olsen et al., 2022).

• Received at least one prior line of systemic therapy.

• At least 18 years of age.

• ECOG performance status ≤ 2

• Adequate counts and organ function as defined below:

‣ ANC ≥ 0.7 x 109/L, without growth factor support (filgrastim or pegfilgrastim) for at least 14 days

⁃ Platelets ≥ 75 x 109/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

⁃ AST(SGOT)/ALT(SGPT) ≤ 2.5 x IULN

⁃ Creatinine clearance \> 30 mL/min by Cockcroft-Gault (using actual body weight) for patients with creatinine levels above institutional normal OR serum creatinine ≤ 1.5 x ULN

• Patients with treated brain metastases are eligible if follow-up brain imaging after CNS-directed therapy shows no evidence of progression.

• The effects of DZR123 on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use highly effective methods of contraception for the duration of study participation and for 183 days after the last dose of DZR123 for female patients and female partners of male patients, or for 93 days after the last dose of DZR123 for male patients and male partners of female patients. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.

• Ability to understand and willingness to sign an IRB approved written informed consent document.

Locations
United States
Missouri
Washington University School of Medicine
RECRUITING
St Louis
Contact Information
Primary
Neha Mehta-Shah, M.D.
mehta-n@wustl.edu
314-747-7510
Time Frame
Start Date: 2024-01-09
Estimated Completion Date: 2030-01-31
Participants
Target number of participants: 36
Treatments
Experimental: Dose De-Escalation Cohort: Tulmimetostat (DZR123)
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.
Experimental: Dose Expansion Cohort: Tulmimetostat (DZR123) - 300 mg
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.
Experimental: Dose Expansion Cohort: Tulmimetostat (DZR123) - 200 mg
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.
Sponsors
Leads: Washington University School of Medicine
Collaborators: The Foundation for Barnes-Jewish Hospital, Swim Across America, Daniel E. Corbin Jr. Lymphoma Fund, Novartis

This content was sourced from clinicaltrials.gov