A Study of Sacituzumab Govitecan in People With Mesothelioma

Inclusion Criteria:

• Patient, or legally authorized representative (LAR), willing and able to providewritten informed consent for the trial

• Patient age ≥ 18 at time of consent

• Pathologically confirmed diffuse pleural mesothelioma

• Must have received at least one prior systemic therapy (platinum/pemetrexed,immunotherapy or a combination thereof)

• Measurable disease as defined primarily by the modified RECIST criteria formesothelioma (at PI discretion RECIST v1.1 may be used)

• Consent to undergo a biopsy prior to Cycle 1 Day 1 and Cycle 3 Day 1 if deemedmedically safe and feasible

• Eastern Cooperative Oncology Group (ECOG) score 0 or Karnofsky Performance Status ≥ 70%

• Adequate organ function, defined as

• Absolute neutrophil count ≥ 1.5K/mcL

• Platelet count ≥ 100K/mcL

• Adequate renal function defined as creatinine clearance ≥ 30ml/min (ascalculated by Cockcroft-Gault Formula)

• Hemoglobin > 9g/dL (prior transfusion permitted if not within 7 days ofenrollment)

• Total bilirubin ≤1.5 x upper limit of normal (ULN) if no liver metastases or <3 × ULN in the presence of documented Gilbert's Syndrome (unconjugatedhyperbilirubinemia) or liver metastases; subjects with Gilbert's syndrome canenroll if conjugated bilirubin is within normal limits

• AST, ALT ≤ 2.5 x ULN (if liver metastases are present, ≤5 × ULN)

• If of childbearing potential, must be willing to use highly effective mode ofcontraception for at least one month prior, during, and for 2 months after the endof active therapy

Exclusion Criteria:

• Currently participating in another study and receiving another study therapy or hasparticipated in a study of an investigational agent and received study therapy orused an investigational device within 3 weeks of the first dose of treatment

• Prior hypersensitivity to irinotecan or any components of sacituzumab govitecan-hziy

• Prior cytotoxic/immunologic systemic therapy within 3 weeks prior to study Day 1 orhas not recovered (i.e., CTCAE v5 ≥ Grade 1 at baseline; from clinically significantadverse events due to a previously administered agent (excluding Grade 2 neuropathy)

• Known psychiatric or substance abuse disorders that would interfere with therequirements of the trial within the opinion of the investigator

• Known additional malignancy that is progressing or requires active treatment.Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of theskin, early stage prostate cancer, or in situ cervical cancer after definitivetreatment

• Positive hepatitis B (hepatitis B virus [HBV]) surface antigen (HBsAg) o NOTE: Subjects with a prior history of HBV demonstrated by positive hepatitis Bcore antibody are eligible if they have at Screening 1) a negative HBsAg and 2) aHBV DNA (viral load) below the lower limit of quantification, per local testing.Patients who fit these criteria must use Hep B prophylaxis during treatment.Subjects with a positive HBsAg due to recent vaccination are eligible if HBV DNA (viral load) is below the lower limit of quantification, per local testing

• Positive hepatitis C antibody (anti-HCV) o NOTE: Subjects with a prior history of HCV, who have completed antiviral treatmentand have subsequently documented HCV RNA below the lower limit of quantification perlocal testing are eligible

• Participant is positive for human immunodeficiency virus (HIV), with 1 or more ofthe following:

• Receiving ART that may interfere with study treatment (consult sponsor forreview of medication prior to enrollment)

• CD4 count < 350 cells/mm3 at screening

• AIDS-defining opportunistic infection within 6 months of start of screening

• Not agreeing to start ART and be on ART > 4 weeks plus having HIV viral load <400 copies/mL at end of 4-week period (to ensure ART is tolerated and HIVcontrolled)

• Myocardial infarction, unstable angina, stroke, transient ischemic attack (TIA), orcoronary/peripheral artery bypass graft, or any acute coronary syndrome within 6months of start of study drug

• Congestive heart failure defined as New York Heart Association (NYHA) Class III-IVor hospitalization for congestive heart failure (any NYHA class) within 6 months ofstudy Day 1

• Pregnant women or women who are breastfeeding or of childbearing potential and notusing a highly effective method of birth control for at least one month prior toenrollment. If the risk of contraception exists, male and female subjects must usehighly effective contraception throughout the study and for at least 60 days afterlast treatment. Highly effective contraception includes either 2 barrier methods (diaphragm, condom by the partner, copper intrauterine device, sponge, orspermicide), or 1 barrier method and 1 hormonal method (any oral, subcutaneous,intrauterine, or intramuscular registered and marketed contraceptive agent thatcontains an estrogen and/or a progesterone agent)