assignment
Not Yet Recruiting

First-in-Human, Open-Label Study of INCA035784 in Adults with Myeloproliferative Neoplasms

Trial ID
2026-525360-18-00
Protocol
INCA035784-101

Trial statistics

location_city
10
research sites
public
3
countries
medical_information
1
disease
person_search
10
investigators

Diseases & Conditions

Participants

The trial enrolled a total of 80 participants diagnosed with Myeloproliferative Neoplasms. Both female and male subjects were included, and the cohort comprised individuals falling within the age range codes “4” and “3”. All enrolled individuals were classified as patients meeting the disease-specific diagnostic criteria, and were selected based on the sponsor’s predefined eligibility parameters. General health status was limited to the presence of the target condition, with no additional lifestyle restrictions reported.

Plans and Procedures

The study is a first‑in‑human, phase 1 investigation of INCA035784 in adults diagnosed with Myeloproliferative Neoplasms, conducted from October 2026 through April 2030. After an initial screening visit to confirm eligibility, participants enter a baseline assessment followed by administration of the investigational product. Subsequent scheduled visits include regular safety and pharmacokinetic assessments, dose‑escalation evaluations, and follow‑up examinations to monitor tolerability and preliminary efficacy. The trial concludes with an end‑of‑study visit during which final safety data are collected and participants are withdrawn from study medication. Overall participant involvement extends from the screening encounter through the end‑of‑study visit, encompassing the full duration of the protocol‑defined treatment and follow‑up periods.

Treatment

No experimental medication, comparator, or standard‑of‑care treatments are specified in the provided source data.

Trial Status by Country

Country Status Start of Recruitment Planned Patients
Belgium BelgiumNot Yet Recruiting30 Oct 202612
Germany GermanyNot Yet Recruiting30 Oct 202612
Italy ItalyNot Yet Recruiting30 Oct 202616

Sites & Investigators

Conditions Studied in This Trial