To Assess the Safety and Tolerability of INCB000928 in Participants With Myelodysplastic Syndromes or Multiple Myeloma.

• Status: Recruiting
• Trial end date: 2023-12-22
• Target enrollment: 0
• Participant gender: All

Summary

This Phase 1/2, open-label, dose-finding study is intended to evaluate the safety and tolerability, PK, PD, and efficacy of INCB000928 administered as monotherapy in participants with MDS or MM who are transfusion-dependent or present with symptomatic anemia.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Incyte Corporation

Criteria

Inclusion Criteria:

• Agreement to avoid pregnancy or fathering children.

• Participants who are transfusion-dependent or present with symptomatic anemia

For MDS participants:

• Ineligible to receive or have not responded to available therapies for anemia such as ESAs or lenalidomide.

• Not requiring cytoreductive therapy other than hydroxyurea.

• BM and peripheral blood myeloblast count < 10%.

• Histologically confirmed diagnosis of the MDS, CMML and unclassifiable MDS/MPN overlap syndromes.

For MM participants:

• Histologically confirmed diagnosis of MM.

• After failure of available standard treatments such as alkylating agents, glucocorticoids, immunomodulatory drugs (lenalidomide,pomalidomide, or thalidomide), proteasome inhibitors (bortezomib or carfilzomib), and daratumumab.

Exclusion Criteria:

• Any prior allogeneic stem cell transplantation or a candidate for such transplantation.

• Any major surgery within 28 days before the first dose of study drug.

• Any prior chemotherapy, immunomodulatory drug therapy, immunosuppressive therapy, biological therapy, endocrine therapy, targeted therapy, or antibody or hypomethylating agent to treat the participant's disease within 5 half-lives or 28 days (whichever is shorter) before the first dose of study drug.

• Undergoing treatment with another investigational medication or having been treated with an investigational medication within 28 days before the first dose of study drug. -Undergoing treatment with ESAs, granulocyte colony-stimulating factor or granulocyte/macrophage colony-stimulating factor, romiplostin, or eltrombopag at any time within 28 days before the first dose of study drug.

• Undergoing treatment with a strong or potent inhibitor or inducer of CYP3A4/5 within 28 days or 5 half-lives (whichever is longer) before the first dose of study drug or expected to receive such treatment during the study.

• History of clinically significant or uncontrolled cardiac disease.

• History or presence of an abnormal ECG that, in the investigator's opinion, is clinically Meaningful.

• Presence of chronic or current active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment.

• Diagnosis of chronic liver disease.