7  INCB160058-101 trial HEM 24055

7.1 MF Cohort

7.1.1 Dose level 1 (50 mg OD)

  • US001-001 started on 50 mg OD and increased to 100 mg OD and increased to 200 mg OD
  • Started 08/2024 and discontinued on 09/25/2025

7.1.2 Dose level 2 (100 mg OD)

3 pts

7.1.2.1 US002-001 (Dr. Mascarenhas)

  • Spleen improved

7.1.2.2 US 002-003

  • Discontinued treatment

7.1.2.3 US003-001 (Dr. Pemmaraju)

  • Creatinine getting better

7.1.3 Dose level 3 (200 mg OD)

5 pts

  • 1 patient is being discontinued at Mount Sinai
7.1.3.0.1 US003-002 (Dr. Pemmaraju)
  • Stable disease

7.1.3.1 US-006-001 (Dr. Rampal)

  • C4D15

What is DLT per protocol?

At least 75% of the dose should be received for DLT evaluation

  • Hematologic
  • General (Grade 2)

7.1.4 Dose level 4 (200 mg BID)

screening

7.1.5 Dose level 5 (400mg BID)

7.2 PV/ET cohort

7.2.1 Dose level 1 (100 mg OD)

7.2.1.1 US007-001 (Dr. Yacoub)

7.2.1.2 US007-002

7.2.1.3 US003-004 (Dr. Pemmaraju)

  • ET patient
  • C5D1
  • Stable

7.2.1.4 US003-006 (Dr. Pemmaraju)

  • PV patient

7.2.1.5 US003-007 (Dr. Pemmaraju)

  • PV patient
  • C2d15

7.2.1.6 US003-008 (Dr. Pemmaraju)

  • ET
  • EOT
  • Grade 3 pruritic rash
  • DLT

7.2.1.7 US007-001 (Dr. Yacoub)

7.2.2 Dose level 2 (200 mg OD)

  • 3 pts

7.2.2.1 US007-004 (Dr. Yacoub)

  • Grade 3 lipase asymptomatic elevation
  • C1D22. Drug is HELD
  • Patient will present for C2D1 10/7/2025