A Study to Evaluate INCA035784 in Participants With Myeloproliferative Neoplasms
ConditionMyeloproliferative Neoplasms
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorIncyte Corporation
About this trial
This study is being conducted to evaluate the safety and tolerability of INCA035784 in participants with myeloproliferative neoplasms.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
DIPSS+ intermediate-2/high-risk MF with prior JAKi, <20% blasts, and measurable spleen
Disqualifiers
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.
Trial design
Design model
Sequential
Treatments tested in this trial
INCA035784
DrugINCA035784 will be administered at the assigned dose in the dose escalation part and at the protocol defined dose in the dose expansion part.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Part 1a: Dose escalationExperimental treatment 1 intervention
Group B: Part 1b: Dose expansionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants with Dose Limiting Toxicities (DLTs)
Dose-limiting toxicity will be defined as the occurrence of any of the toxicities as per protocol.
Time frame
Up to 28 days2
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug up to 90 days after the last dose of study drug.
Time frame
Up to approximately 2 years and 90 days3
Number of participants with TEAEs leading to treatment interruption, discontinuation, or delay
Number of participants with TEAEs leading to treatment interruption, discontinuation, or delay.
Time frame
Up to approximately 2 years and 90 daysSecondary outcomes
1
Number of participants with TEAEs leading to dose modification or discontinuation
Number of participants with TEAEs leading to dose modification or discontinuation.
Time frame
Up to approximately 2 years and 90 days2
Participants with MF: Response using the revised International Working Group for Myelofibrosis Research and Treatment (IWG-MRT) and European LeukemiaNet (ELN) response criteria for myelofibrosis (MF)
Defined as the percentage of participants with Response using the revised IWG-MRT and ELN response criteria.
Time frame
Up to approximately 2 years and 90 days3
Participants with essential thrombocythemia (ET): Response using the revised IWG-MRT and ELN response criteria for ET
Defined as the percentage of participants with Response using the revised IWG-MRT and ELN response criteria.
Time frame
Up to approximately 2 years and 90 days4
Participants with symptomatic anemia: Anemia response
Anemia response as defined in the protocol.
Time frame
Up to approximately 2 years and 90 daysSponsors and contacts
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Source ClinicalTrials.gov