A Study of Avutometinib + Defactinib in Recurrent Low-Grade Serous Ovarian Cancer in Japanese Patients

Inclusion Criteria:

• Histologically proven LGSOC (ovarian, peritoneal)

• Documented mutational status of KRAS by validated diagnostic test of tumor tissue

• Documented disease progression (radiographic or clinical) or recurrence of LGSOC andhave received at least one platinum-based chemotherapy agent

• Measurable disease according to RECIST 1.1

• An Eastern Cooperative Group (ECOG) performance status ≤ 1.

• Adequate organ function

• Adequate recovery from toxicities related to prior treatments

• Agreement to use highly effective method of contraceptive, if necessary

Exclusion Criteria:

• Systemic anti-cancer therapy within 4 weeks of the first dose of study therapy

• Co-existing high-grade ovarian cancer or another histology

• History of prior malignancy, excluding ovarian cancer, with recurrence <3 years fromthe time of enrollment

• Major surgery within 4 weeks

• Symptomatic brain metastases requiring steroids or other interventions

• Known SARS-Cov2 infection (clinical symptoms) ≤28 days prior to first dose of studytherapy

• For subjects with prior MEK exposure, Grade 4 toxicity deemed related to the MEKinhibitor

• Active skin disorder that has required systemic therapy within the past year

• History of rhabdomyolysis

• Concurrent ocular disorders

• Concurrent heart disease or severe obstructive pulmonary disease

• Patients with the inability to swallow oral medications