A Phase 1 Study of SY-1365, a SelectiveCDK7 Inhibitor, in Adult Patients with Advanced Solid Tumors
Preliminary anti-tumor activity will be evaluated in approximately 102 patients in 5 cohorts of Part 2, with SY-1365 administered alone, in combination with carboplatin, or in combination with fulvestrant. Part 2 will consist of five cohorts:
Cohort 1: approximately 24 patients with advanced ovarian cancer with 3+ previous lines of treatment. Monotherapy
Cohort 2: approximately 24 patients with relapsed ovarian cancer with previous platinum therapy. SY-1365 + Carboplatin
Cohort 3: approximately 12 patients with primary platinum refractory ovarian cancer. Monotherapy
Cohort 4: approximately 20-30 patients with biopsy-accessible, advanced solid tumors of any histology. Monotherapy.
Cohort 5: approximately 12 patients with HR+ metastatic breast cancer post CDK4/6 + aromatase inhibitor treatment. SY-1365 + fulvestrant.
View study details on ClinicalTrials.gov
February 01, 2019