Phase 1 Open‑Label Multicenter Study of INCA036978 in Adults with Myeloproliferative Neoplasms

The trial enrolled 158 individuals diagnosed with Myeloproliferative Neoplasms. Both female and male participants were included, and the cohort encompassed vulnerable subjects as defined by regulatory criteria. Subjects were classified as patients and were selected to represent the age categories corresponding to codes 3 and 4. Enrollment required a confirmed diagnosis of the specified condition; no additional lifestyle restrictions such as diet or physical activity were stipulated in the provided information.

The study is a Phase 1, open‑label, multicenter trial evaluating INCA036978 in adults with myeloproliferative neoplasms. The design is non‑randomized and uncontrolled, with participants screened during an initial visit to confirm eligibility, followed by a baseline visit in which the investigational product is administered. Subsequent follow‑up visits occur at predefined intervals to assess safety, pharmacokinetics, and tolerability, culminating in an end‑of‑study visit during which final assessments are performed. Participant involvement extends from the screening visit through the end‑of‑study visit, with the overall trial period spanning from the projected recruitment start on 1 September 2026 to the estimated study completion on 9 June 2030. Early termination may occur if a participant experiences a serious adverse event, withdraws consent, or fails to comply with protocol requirements.

No product information was provided for the experimental medication, comparator, or standard‑of‑care treatments; therefore, specific details regarding formulation, dosage, administration route, frequency, dosing schedule, or compliance monitoring cannot be described.

Efficacy will be evaluated using predefined endpoints as outlined in the study protocol.