Ovarian Cancer Clinical Trials

⁃ For Part 1:

• Histologically or cytologically confirmed FIGO Stage III/IV high-grade serous or endometrioid ovarian, fallopian tube, or peritoneal carcinoma.

• Subjects must have received 1 or 2 prior therapeutic regimens/lines of therapy in the advanced or metastatic setting. At least one regimen must have contained cisplatin or carboplatin.

• The disease must be platinum resistant (ie, the PFI must have been \< 6 months). Platinum refractory disease (ie, PD during first-line platinum-based therapy) is allowed.

⁃ For Part 2 Dose Escalation:

⁃ Prior therapy:

⁃ • Subjects must have received 6 cycles of platinum-based doublet chemotherapy in the 1L or 2L setting as their most recent therapy

⁃ Response to prior platinum therapy:

⁃ In the 1L setting: Complete Response, Partial Response, or Stable Disease to platinum-based chemotherapy.

⁃ In the 2L setting:

∙ Progressive Disease \>183 days after receiving the last dose of platinum chemotherapy in the 1L setting,

‣ Complete Response, Partial Response, or Stable Disease to 2L platinum-based chemotherapy.

• Adequate hematologic, and organ function

⁃ For Part 2 Dose Expansion:

• Subjects must have at least 4 cycles of platinum-based chemotherapy in 2L and have Complete Response, Partial Response, or Stable Disease

• Subjects must have progressed while on a PARP inhibitor for 1L maintenance Additional protocol-defined inclusion criteria may apply