A Phase II Trial of Sacituzumab Govitecan in Patients With Advanced Thymic Epithelial Tumors

Inclusion Criteria:

• Age >/= 18 years at time of signing informed consent form (ICF)

• Ability to understand and the willingness to sign a written informed consentdocument

• Patients with histologically confirmed advanced thymoma or thymic carcinoma

• Patients who have experienced disease progression after treatment with at least oneprior systemic therapy

• Measurable disease per RECIST v1.1

• Availability of pre-treatment tumor tissue (archival or fresh); If archival tissueis not available and a fresh biopsy is not considered safe and medically feasible bythe Investigator, the patient may be approved for enrollment after consultation withthe Principal Investigator

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2

• Adequate hematologic and end-organ function, defined by the following laboratorytest results, obtained within 14 days prior to initiation of study treatment:

• Absolute neutrophil count (ANC) >/= 1.5 x 10^9/L (1500/uL) without filgrastimsupport

• Platelet count >/= 100 x 10^9/L (100,000/uL) without transfusion

• Hemoglobin (Hgb) >/= 80 g/L (8 g/dL). Patients may be transfused to meet thiscriterion.

• Aspartate aminotransferase (AST), alanine transaminase (ALT), and alkalinephosphatase (ALP) </= 2.5 x upper limit of normal (ULN), with the followingexceptions:

• Patients with documented liver metastases: AST and ALT </= 5 x ULN

• Patients with documented liver or bone metastases: ALP </= 5 x ULN Serumbilirubin </= 1.5 x ULN with the following exception: patients with knownGilbert disease: serum bilirubin </= 3 x ULN

• Creatinine clearance >/= 30 mL/min (calculated using the Cockcroft-Gault formula,see Appendix 2)

• For patients not receiving therapeutic anticoagulation: INR and aPTT </= 1.5 x ULN

• Patients with human immunodeficiency virus (HIV) on effective anti-retroviraltherapy with undetectable viral load are eligible for this trial

• For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBVviral load must be undetectable or on suppressive therapy, if indicated. Patientswith a history of hepatitis C virus (HCV) infection must have been treated. Forpatients with HCV infection who are currently on treatment, they are eligible ifthey have an undetectable HCV viral load.

• Patients with prior or concurrent malignancy whose natural history or treatment doesnot have the potential to interfere with the safety or efficacy assessment of theinvestigational regimen are eligible for this trial

• For women of childbearing potential: agreement to remain abstinent (refrain fromheterosexual intercourse) or use contraceptive methods, and agreement to refrainfrom donating eggs, as defined below:

• Women must remain abstinent or use contraceptive methods with a failure rate of < 1% per year during the treatment period and for 6 months after the final doseof study treatment. Women must refrain from donating eggs during this sameperiod.

• A woman is considered to be of childbearing potential if she is postmenarchal,has not reached a postmenopausal state (>/= 12 continuous months of amenorrheawith no identified cause other than menopause), and has not undergone surgicalsterilization (removal of ovaries and/or uterus). The definition ofchildbearing potential may be adapted for alignment with local guidelines orrequirements.

• Examples of contraceptive methods with a failure rate of > 1% per year includebilateral tubal ligation, male sterilization, hormonal contraceptives thatinhibit ovulation, hormone-releasing intrauterine devices, and copperintrauterine devices.

• The reliability of sexual abstinence should be evaluated in relation to theduration of the clinical trial and the preferred and usual lifestyle of thepatient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, orpostovulation methods) and withdrawal are not adequate methods ofcontraception.

• For men: agreement to remain abstinent (refrain from heterosexual intercourse) oruse contraceptive measures, and agreement to refrain from donating sperm, as definedbelow:

• With a female partner of childbearing potential who is not pregnant, men whoare not surgically sterile must remain abstinent or use a condom plus anadditional contraceptive method that together result in a failure rate of < 1%per year during the treatment period and for 90 days after the final dose ofsacituzumab govitecan-hziy. Men must refrain from donating sperm during thisthis same period.

• With a pregnant female partner, men must remain abstinent or use a condomduring the treatment period and 90 days after the final dose of sacituzumabgovitecan-hziy to avoid potential exposure to the embryo.

• The reliability of sexual abstinence should be evaluated in relation to theduration of the clinical trial and the preferred and usual lifestyle of thepatient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, orpostovulation methods) and withdrawal are not adequate methods ofcontraception.

Exclusion Criteria:

• Any other disease, metabolic dysfunction, physical examination finding, or clinicallaboratory finding that, in the view of the investigator, contraindicates the use ofan investigational drug, may affect the interpretation of the results, or may renderthe patient at high risk from treatment complications.

• Pregnancy or breastfeeding, or intention of becoming pregnant during study treatmentor within 6 months after the final dose of study treatment.

• Symptomatic brain metastasis requiring corticosteroids. Patients with treated brainmetastases are eligible.

• No concurrent therapy with approved or investigational anticancer therapeutics