A Study to Evaluate INCA035784 in Participants With Myeloproliferative Neoplasms

Incyte

Status and phase: Enrolling; Phase 1

Conditions: Myeloproliferative Neoplasms

Treatments: Drug: INCA035784

Study type: Interventional

Funder types: Industry

Identifiers

NCT07008118

INCA035784-101

Details and patient eligibility

About

This study is being conducted to evaluate the safety and tolerability of INCA035784 in participants with myeloproliferative neoplasms.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 years or older at the time of signing the ICF

• ECOG performance status of 0 to 1 for the dose escalation (Part 1a) and 0 to 2 for the dose expansion (Part 1b)

• Documented CALR exon-9 mutation

• Confirmed diagnosis of MPN according to the 2022 ICC criteria:

  • DIPSS+ intermediate-2/high-risk MF with prior JAKi, <20% blasts, and measurable spleen
  • High-risk ET with platelets >450×10⁹/L

• Resistant, refractory, intolerant, or has lost response to ≥1 prior line of therapy for MF and ≥2 prior lines for ET

• No prior stem cell transplant and none planned within 6 months

• Minimum Laboratory Requirements:

  • Platelet count ≥50 × 10⁹/L
  • Absolute neutrophil count ≥1 × 10⁹/L
  • International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤1.5 × upper limit of normal (ULN), unless receiving vitamin K antagonists
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <2.5 × ULN
  • Total bilirubin <2 × ULN
  • Estimated creatinine clearance >45 or >30 mL/min (depending on study part)

Exclusion criteria

• Major bleeding or thrombosis (e.g., stroke, DVT, PE) within the past 3 months
• Active or high-risk HBV, HCV, or HIV infection, or other chronic active infections requiring systemic treatment
• Active invasive cancer within the past 2 years, except certain early-stage or low-risk cancers (e.g., resected skin, cervical, thyroid, or prostate cancer)
• Pregnant or unwilling to avoid pregnancy or fathering a child during the study and for a defined period after the last dose.

Other protocol-defined Inclusion/Exclusion Criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Part 1a: Dose escalation

Experimental group

Description:

INCA035784 will be administered at a protocol defined starting regimen in 28-day cycles as monotherapy to identify the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE\[s\]). Participants with myeloproliferative neoplasm (MPN) will enroll in this group.

Treatment:

Drug: INCA035784

Part 1b: Dose expansion

Experimental group

Description:

INCA035784 will be administered as monotherapy at the RDE(s) identified during Part 1a. Participants with myeloproliferative neoplasm (MPN) will enroll in this group.

Treatment:

Drug: INCA035784