Study of Sacituzumab Govitecan in Patients With Solid Tumor

Key Inclusion Criteria:

• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.

• Histologically or cytologically-documented, incurable locally advanced or metastaticsolid tumor of one of the following types:

• Cohort A: oesophageal squamous-cell carcinoma that was refractory or intolerantto fluoropyrimidine-based, platinum-based, and taxane-based chemotherapy.

• Cohort B: gastric adenocarcinoma that was refractory or intolerant tofluoropyrimidine-based, platinum-based, and taxane-based chemotherapy.

• Cohort C: cervical cancer that was refractory or intolerant to platinum-basedand taxane-based chemotherapy.

• Cohort D: biliary tract cancer, including intrahepatic cholangiocarcinoma (IHCC), extrahepatic cholangiocarcinoma (EHCC), and gallbladder cancer (GBC),with exception of ampullary carcinoma, progressed during or after first lineplatinum-based or fluoropyrimidine-based chemotherapy.

• Cohort E: lung adenocarcinoma with activating genomic alterations (EGFR/ ALK/ROS1/ BRAF/ MET/ RET) that was refractory or intolerant to targeted tyrosinekinase inhibitors (TKIs) and had not received platinum-based chemotherapy forunresectable local advanced or metastatic disease, and no suitable or willingto receive platinum-based chemotherapy.

• Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI)in accordance with RECIST v 1.1, bone-only disease is not measurable and is notpermitted.

• Availability of archival tumor tissue or newly acquired biopsy (unstaining tumorslides, recommended from metastasis sites).

• Adequate bone marrow, hepatic and renal function.

• Recovered from all prior treatment-related toxicities to Grade 1 or less byNCI-CTCAE v 5.0 (except alopecia or peripheral neuropathy that may be Grade 2 orless).

• Individuals must have completed all prior cancer treatments at least 2 weeks priorto the first dose including chemotherapy , radiotherapy and major surgery. Priorantibody treatment for cancer must have been completed at least 3 weeks prior to thefirst dose.

• Individuals must have at least a 3-month life expectancy.

Key Exclusion Criteria:

• Previous treatment with topoisomerase I inhibitors as a free form or as otherformulations.

• Previous treatment with Trop-2 targeted therapy.

• Individuals with a history of or current central nervous system (CNS) metastases.

• Known additional malignancy within 3 years prior to enrollment with the exception ofcuratively treated basal cell carcinoma of the skin, squamous cell carcinoma of theskin and/or curatively resected in situ cancers.

• Individuals known to be human immunodeficiency virus positive.

• Individuals with active hepatitis B virus (HBV), or hepatitis C virus (HCV)infection. Hepatitis B core antibody (HBcAb) testing is required and if positive,then HBV DNA testing will be performed and if positive the individual will beexcluded.

• Known history of unstable angina, myocardial infarction (MI), or chronic heartfailure present within 6 months of first dose or clinically significant cardiacarrhythmia (other than stable atrial fibrillation) requiring anti-arrhythmia therapyor left ventricular ejection fraction < 50%.

• Known history of clinically significant active chronic obstructive pulmonarydisease, or other moderate-to-severe chronic respiratory illness present within 6months of the first dose.

• Infection requiring systematic antibiotic use within 1 week of the first dose.

• Individuals with active chronic inflammatory bowel disease (ulcerative colitis,Crohn disease) and individuals with a history of bowel obstruction orgastrointestinal (GI) perforation.

• High dose systemic corticosteroids within 2 weeks prior to the first dose (however,low dose corticosteroids ≤ 10 mg prednisone or equivalent daily are permittedprovided the dose is stable for 4 weeks).

• Individuals who have received a live vaccine within 30 days of first dose.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.