Phase 2 Study of PI3K Inhibitor Copanlisib in Combination With Fulvestrant in Selected ER+ and/or PR+ Cancers With PI3K (PIK3CA, PIK3R1) and/or PTEN Alterations

Inclusion criteria

• ✓. Histologically confirmed ER+ and/or PR+ advanced or metastatic solid cancer including ovarian cancer (cohort 1), endometrial cancer (cohort 2), or breast cancer (cohort 3) (Figure 1). ER and/or PR positivity is defined as \>10% immunohistochemical staining of any intensity. Cohort 3 will be enriched to include at least 7 patients naive to any PI3Ki in Stage 1 and also in Stage 2.
• ✓. Presence of one or more PI3K and/or PTEN alterations in tumor tissue. Genetic alterations will include PIK3CA gain of function mutations, PIK3R1 loss of function mutations, PTEN loss of function mutations, and PTEN deletions.
• ✓. Measurable disease per the RECIST 1.1.
• ✓. The patient (or legally acceptable representative, if applicable) provides written informed consent for the study.
• ✓. Female or male ≥18 years of age on the day of informed consent signing.
• ✓. Patients have no available standard therapy known to prolong survival. For cohort 3 only, prior treatment with aPI3Ki or everolimus is not required and patients with or without prior PI3Ki or everolimus will be qualified for enrollment
• ✓. Adequate archived tumor tissue for the analysis for PI3K and PTEN alterations if available.
• ✓. Eastern Cooperative Oncology Group (ECOG) performance status of .2.