A Phase 2 Open Label Study of Sacituzumab Govitecan (IMMU-132) in Subjects With Metastatic Solid Tumors

This is a multi-cohort, open-label, Phase 2 study designed to assess the clinical activity of sacituzumab govitecan in adult subjects with metastatic solid tumors with elevated Trop-2 expression.

Inclusion Criteria:

• Female or male subjects, >18 years of age, able to understand and give written informed consent.
• Subjects with the following histologically documented metastatic (M1, Stage IV) or locally advanced solid tumors. NSCLC (adenocarcinoma or SCC), that has progressed after one line of platinum-based chemotherapy and PD-L1 or PD-1 directed therapy; recurrence/ relapse or lack of response within 6 months of completion of chemotherapy for locally advanced disease, that line of therapy may be counted for eligibility. Relapsed unresectable endometrial cancer that has progressed after prior platinum-based chemotherapy or is refractory to platinum-based chemotherapy.
• Eastern Cooperative Oncology Group (ECOG) Performance status score of 0 or 1 (see Appendix 1)
• Adequate hematologic counts without transfusional or growth factor support within 2 weeks of study drug initiation
• Adequate hepatic function
• Subject must have at least a 3-month life expectancy.
• Have measurable disease by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria (see Appendix 4). Tumor lesions situated in a previously irradiated area may be utilized if they are considered measurable and progression has been demonstrated in such lesions.

Exclusion Criteria:

• Hepatitis B/C
• Has had a prior anti-cancer biologic agent within 4 weeks prior to study Day 1 or have had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1.
• Have not recovered (i.e., ≤ Grade 1) from adverse events due to a previously administered agent
• Have previously received topoisomerase I inhibitors
• Have an active second malignancy
• Have known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they have stable CNS disease for at least 4 weeks prior to the first dose of study drug and all neurologic symptoms have returned to baseline, have no evidence of new or enlarging brain metastases and are taking ≤20 mg/day of prednisone or its equivalent. All subjects with carcinomatous meningitis are excluded regardless of clinical stability