Study of INCA036978 in Participants With Myeloproliferative Neoplasms

Condition(s) studied

Investigational drug(s) / intervention(s)

INCA036978: INCA036978 will be administered at protocol defined dose.

Standard disease-directed therapy: A standard disease-directed therapy will be administered according to Prescribing Information/SmPC.

Study summary

This study will be conducted to determine the safety, tolerability, dose-limiting toxicity (DLT)s, and maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE)s of INCA036978 administered as monotherapy and in combination with a standard disease-directed therapy.

Eligibility

Primary outcome measure(s)

• Number of participants with Dose Limiting Toxicities (DLT)s in Part 1 — Up to 28 days
  Dose-limiting toxicity will be defined as the occurrence of any of the toxicities as per protocol.
• Number of participants with Treatment-emergent Adverse Events (TEAEs) — Up to approximately 2 years
  Defined as adverse events AE (either reported for the first time or the worsening of a pre-existing event) occurring after the first dose of study drug and up to 60 days after last dose of study drug or until the start of a new disease-directed therapy, whichever occurs first.
• Number of participants with TEAEs leading to dose modification or discontinuation — Up to approximately 2 years
  Number of participants with TEAEs leading to study drug modifications (interruptions, dose reduction) or discontinuation.

Trial sites (54)

+ 14 more sites — see the full list on the official registry below.

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