Recruiting NCT07441694
Study of INCA036978 in Participants With Myeloproliferative Neoplasms
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: INCA036978, Standard disease-directed therapy.
- Who it may be relevant to
- Registry conditions: Myeloproliferative Neoplasms. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, Belgium, Canada, France +6
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 1, Open-Label, Multicenter Study of INCA036978 in Participants With Myeloproliferative Neoplasms
Overview
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.
Interventions
- Drug INCA036978
INCA036978 will be administered at protocol defined dose. - Drug Standard disease-directed therapy
A standard disease-directed therapy will be administered according to Prescribing Information/SmPC.
Primary outcome measures
- Number of participants with Dose Limiting Toxicities (DLT)s in Part 1 [Time frame: Up to 28 days]
- Number of participants with Treatment-emergent Adverse Events (TEAEs) [Time frame: Up to approximately 2 years]
- Number of participants with TEAEs leading to dose modification or discontinuation [Time frame: Up to approximately 2 years]
Secondary outcome measures (12)
- Pharmacokinetics Parameter: Cmax of INCA036978 [Time frame: Up to approximately 2 years]
- Pharmacokinetics Parameter: Tmax of INCA036978 [Time frame: Up to approximately 2 years]
- Pharmacokinetics Parameter: Cmax,ss of INCA036978 [Time frame: Up to approximately 2 years]
- Pharmacokinetics Parameter: Cmin,ss of INCA036978 [Time frame: Up to approximately 2 years]
- Pharmacokinetics Parameter: AUC(0-t) of INCA036978 [Time frame: Up to approximately 2 years]
- Pharmacokinetics Parameter: AUC 0-∞ of INCA036978 [Time frame: Up to approximately 2 years]
- Pharmacokinetics Parameter: CL/F of INCA036978 [Time frame: Up to approximately 2 years]
- Pharmacokinetics Parameter: Vz/F of INCA036978 [Time frame: Up to approximately 2 years]
- Pharmacokinetics Parameter: t1/2 of INCA036978 [Time frame: Up to approximately 2 years]
- For participants with myelofibrosis (MF): Percentage of participants achieving spleen volume reduction as defined in the protocol [Time frame: Week 12 and Week 24]
- For participants with MF and anemia: Anemia Response as defined in the protocol [Time frame: Up to approximately 2 years]
- For participants with polycythemia vera (PV): Peripheral blood count remission as defined by the protocol. [Time frame: Up to approximately 2 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 23 centers
- University of Alabama At Birmingham — Birmingham
- City of Hope-Lennar Foundation Cancer Center — Irvine
- Usc Norris Comprehensive Cancer Center — Los Angeles
- UCLA Medical Hematology & Oncology — Los Angeles
- Yale Cancer Center — New Haven
- University of Miami — Miami
- Moffitt Cancer Center — Tampa
- Winship Cancer Institute of Emory University — Atlanta
- … and 15 more centers
Australia · 5 centers
- Concord General Repatriation Hospital — Concord
- Royal North Shore Hospital — St Leonards
- Icon Cancer Centre — Auchenflower
- Epworth Health Care — East Melbourne
- Linear Clinical Research — Nedlands
Germany · 5 centers
- University Medical Center Rwth Aachen — Aachen
- Charite Universitaetsmedizin Berlin - Campus Charite Mitte — Berlin
- Universitatklinikum Freiburg — Freiburg im Breisgau
- Universitatsklinikum Halle (Saale) — Halle
- Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii — Mainz
Italy · 4 centers
- Aou Policlinico S. Orsola-Malpighi — Bologna
- Fondazione Irccs Ca' Granda - Ospedale Maggiore Policlinico — Milan
- A. Gemelli University Hospital, Catholic University of the Sacred Heart — Roma
- Azienda Sanitaria Universitaria Friuli Centrale Asu Fc — Udine
France · 3 centers
- Institut Bergonie — Bordeaux
- Hospital Saint Louis — Paris
- Institut Gustave Roussy — Villejuif
Spain · 3 centers
- Hospital Universitari Germans Trias I Pujol — Badalona
- Hospital Universitario de Gran Canaria Dr. Negrin — Las Palmas de Gran Canaria
- Hospital Universitario 12 de Octubre — Madrid
United Kingdom · 3 centers
- Guy'S Hospital - Guy'S & St Thomas' Nhs Foundation Trust — London
- Nottingham University Hospitals — Nottingham
- University of Oxford — Oxford
Belgium · 2 centers
- Centre Hospitalier Universitaire (Chu) de Liege — Liège
- AZ DELTA — Roeselare
Canada · 2 centers
- Princess Margaret Cancer Center — Toronto
- McGill University Jewish General Hospital — Montreal
Japan · 2 centers
- National Cancer Center Hospital East — Kashiwa Chiba
- Ehime University Hospital — Toon, Ehime
South Korea · 2 centers
- Seoul National University Hospital — Jongno-gu, Seoul
- The Catholic University of Korea Seoul St. Mary'S Hospital — Seocho-gu, Seoul
Identifiers
NCT: NCT07441694 · INCA036978-101 · 2026-525217-31-00