Study of INCA036978 in Participants With Myeloproliferative Neoplasms

Incyte

Status and phase

Enrolling

Phase 1

Conditions

Myeloproliferative Neoplasms

Treatments

Drug: Standard disease-directed therapy

Drug: INCA036978

Study type

Interventional

Funder types

Industry

Identifiers

NCT07441694

INCA036978-101

Details and patient eligibility

About

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.

Enrollment

218 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Life expectancy > 6 months.
Willingness to undergo a pretreatment and limited on-study BM biopsies and aspirates (as appropriate to disease).
Participants with MF, PV and ET as defined in the protocol.

Exclusion criteria

Presence of any hematological malignancy other than MF, PV, or ET.
Malignancy within the last 3 years prior to enrollment.
Acute or chronic HBV, Active HCV or known HIV or tuberculosis infection.
Clinically significant or uncontrolled cardiac disease.
Has undergone any prior allogeneic stem-cell transplantation or such transplantation is planned in the next 6 months.
Laboratory values outside the Protocol-defined ranges.
Prior history of major bleeding or thrombosis within the last 3 months prior to study enrollment.
Presence of chronic or current active infectious disease requiring systemic treatment.
Treatment with an MPN-directed therapy (approved or investigational) within the per protocol threshold before the administration of study drug.
Prior radiation therapy within 28 days before the first dose of study treatment.

Other protocol-defined Inclusion/Exclusion Criteria may apply.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

218 participants in 4 patient groups

Part 1a: Dose Escalation

Experimental group

Description:

INCA036978 will be administered at a protocol defined starting regimen as monotherapy to identify the MTD and/or RDE(s).

Treatment:

Drug: INCA036978

Part 1b: Dose Escalation

Experimental group

Description:

INCA036978 will be administered at a protocol defined starting regimen in combination with a standard disease-directed therapy to identify the MTD and/or RDE(s).

Treatment:

Drug: INCA036978

Drug: Standard disease-directed therapy

Part 2a: Dose Expansion

Experimental group

Description:

INCA036978 will be administered as monotherapy at the RDE(s) identified during Part 1

Treatment:

Drug: INCA036978

Part 2b: Dose Expansion

Experimental group

Description: