Study of Vimseltinib (DCC-3014) in Patients With Advanced Tumors and Tenosynovial Giant Cell Tumor

Exclusion Criteria

• •Dose Escalation Phase:
• •1. Received anticancer therapy or therapy for TGCT, including investigational therapy, within 2 weeks or 28 days for therapies with half-life (t1/2) longer than 3 days prior to the administration of study drug.
• •2. Unresolved toxicity (Grade \>1 or baseline) from previous anticancer therapy or TGCT therapy, excluding alopecia.
• •3. Known active central nervous system (CNS) metastases.
• •4. History or presence of clinically relevant cardiovascular abnormalities.
• •5. Systemic arterial or venous thrombotic or embolic events.
• •6. QT interval corrected by Fridericia's formula (QTcF) \>450 ms in males or \>470 ms in females or history of long QT syndrome.
• •7. Left ventricular ejection fraction (LVEF) \<50%.
• •8. Concurrent treatment with proton-pump inhibitor(s).
• •9. Major surgery within 2 weeks of the first dose of study drug.
• •10. Malabsorption syndrome or other illness that could affect oral absorption.
• •11. Known human immunodeficiency virus, active hepatitis B, active hepatitis C, or active mycobacterium tuberculosis infection.
• •12. If female, the patient is pregnant or lactating.
• •13. Known allergy or hypersensitivity to any component of the study drug.
• •14. Any other clinically significant comorbidities.
• •Expansion Phase (Cohorts A and B)
• •1. Expansion Cohort A: received systemic therapy targeting CSF1 or CSF1R; previous therapy with imatinib and nilotinib is allowed.
• •2. Expansion Cohort B: discontinued systemic therapy targeting anti-CSF1 or anti-CSF1R due to drug-induced liver injury.
• •3. Treatment with therapy for TGCT, including investigational therapy, within 2 weeks or 28 days for therapies with a t1/2 longer than 3 days prior to the administration of the study drug.
• •4. Known metastatic TGCT or other active cancer that requires concurrent treatment.
• •5. QT interval corrected by Fridericia's formula (QTcF) \>450 ms in males or \>470 ms in females or history of long QT syndrome.
• •6. Left ventricular ejection fraction (LVEF) \<55%.
• •7. Concurrent treatment with proton-pump inhibitor(s).
• •8. Major surgery within 2 weeks of the first dose of study drug.
• •9. Any clinically significant comorbidities
• •10. Malabsorption syndrome or other illness that could affect oral absorption.
• •11. Known human immunodeficiency virus (HIV), active or chronic hepatitis B, active or chronic hepatitis C, or active mycobacterium tuberculosis infection.
• •12. If female, the patient is pregnant or lactating.
• •13. Known allergy or hypersensitivity to any component of the study drug.
• •14. Contraindication for MRI
• •15. Active liver or biliary disease, including evidence of fatty liver, nonalcoholic steatohepatitis (NASH), or cirrhosis