Study Evaluating Treatment of Sacituzumab-govitecan for Patients With Metastatic Esophagogastric Adenocarcinoma

Inclusion Criteria:

1. Patient* has given written informed consent.

2. Patient is, in the investigator's judgement, willing and able to comply with thestudy protocol.

3. Patient is ≥ 18 years of age at time of signing the written informed consent.

4. Patient has been diagnosed with histologically confirmed metastatic (stage IV)esophagogastric adenocarcinoma.

5. Patient has received at least one prior therapy containing platinum compound and afluoropyrimidine, potentially combined with immunotherapy, in the metastaticsetting. Neoadjuvant/adjuvant platinum-fluoropyrimidine treatment is counted asfirst-line therapy if disease progression occurred within 6 months after completionof treatment. NOTE: patients with advanced MSI-h/dMMR tumors who have not previously been treatedwith pembrolizumab, nivolumab or any other PD-1/PD-L1 inhibitor are not permittedfor inclusion.

6. Patient has an ECOG performance status ≤ 1.

7. Patient must have an estimated life expectancy of at least 12 weeks.

8. Patient has at least one measurable lesion on radiographic imaging as defined byRECIST v1.1.

9. Patient has adequate hematological, hepatic and renal function as indicated by thefollowing parameters:

10. Leukocytes ≥ 2,500/μL, platelets ≥ 100,000/μL without transfusion, absoluteneutrophil count (ANC) ≥ 1,500/μL without granulocyte colony-stimulating factorsupport, hemoglobin ≥ 90 g/L (9 g/dL) - Patients may be transfused to meet thiscriterion.

11. Bilirubin ≤ 1.5 x upper limit of normal (ULN), aspartate transaminase andalanine transaminase ≤ 2.5 x ULN (≤ 5 x ULN in case of liver metastases),alkaline phosphatase ≤ 2.5 x ULN (≤ 5 x ULN in case of liver metastases)

12. Serum creatinine ≤ 1.5 x ULN, or glomerular filtration rate > 45 mL/min (calculated per institutional standard)

13. Serum albumin ≥ 25 g/L (2.5 g/dL)

14. For patients not receiving therapeutic anticoagulation: INR or aPTT ≤ 1.5 xULN; for patients receiving therapeutic anticoagulation: stable anticoagulantregimen

15. Patient must be willing to provide liquid biopsy samples for the translationalresearch program.

16. Female patients of childbearing potential and male patients with female partners ofchildbearing potential must agree to remain abstinent (refrain from heterosexualintercourse) or use contraceptive methods that result in a failure rate of <1% peryear during the treatment period and for at least 6 months after the last studytreatment. Male patients must refrain from donating sperm during this same period.Male patients with a pregnant partner must agree to

Exclusion Criteria:

1. Patient has known hypersensitivity to any component of the Sacituzumab-govitecanformulation as well as a known history of severe allergic, anaphylactic or otherhypersensitivity reactions to chimeric or humanized antibodies or fusion protein.

2. Patient has received previously topoisomerase 1 inhibitors such as irinotecan, ornal-irinotecan

3. Patient has an active second malignancy. Note: patients with a history of malignancythat have been completely treated, with no evidence of active cancer for 3 yearsprior to enrollment, or patients with surgically cured tumors with low risk ofrecurrence (e.g., non-melanoma skin cancer, histologically confirmed completeexcision of carcinoma in situ, or similar) are allowed to enroll

4. Patients with known, untreated and active (not stable within the last 4 weeks orsymptomatic) brain metastases and patients with leptomeningeal disease.

5. Patient meets any of the following criteria for cardiac disease:

6. Myocardial infarction or unstable angina pectoris within 6 months prior toinitiation of study treatment

7. History of serious ventricular arrhythmia (i.e., ventricular tachycardia orventricular fibrillation), high-grade atrioventricular bock, or other cardiacarrhythmias requiring antiarrhythmic medications (except for atrialfibrillation that is well controlled with antiarrhythmic medication); historyof QT interval prolongation

8. New York Heart Associated (NYHA) class III or greater congestive heart failureor left ventricular ejection fraction (LVEF) of < 40% if echocardiography hasbeen performed

9. Patient has an active chronic inflammatory bowel disease (ulcerative colitis,Crohn's disease) or gastrointestinal perforation within 6 months prior to initiationof study treatment

10. Patient has an active serious infection requiring antibiotic treatment

11. Patient has known history of human immune deficiency virus (HIV, or positive HIVantibody, if done at screening) with detectable viral load OR taking medicationsthat may interfere with SN-38 metabolism

12. Patient has active hepatitis B or C virus (HBV/HCV). In patients with a history ofHBV or HCV, patients with detectable viral loads will be excluded

13. Patient participated in another interventional clinical study ≤ 14 days prior toinitiation of study treatment or at the same time as this study.

14. Patient has taken an investigational drug within 14 days or 5 half-lives (whicheveris longer) prior to initiation of study treatment.

15. Patient received anticancer biologic agent within 28 days or targeted smallmolecule, radiation or chemotherapy within 14 days prior to initiation of the studytreatment.

16. Patient has not recovered from AEs due to previously administered drug (i.e., ≥grade 2 is concerned as not recovered)

17. Patients with any grade of alopecia are an exception to this criterion and willqualify for the study

18. If patients received major surgery, they must have recovered adequately fromthe toxicity and/or complications from the intervention prior to starting studytreatment

19. Patient has evidence of any other disease, neurologic or metabolic dysfunction,physical examination finding or laboratory finding giving reasonable suspicion of adisease or condition that contraindicates the use of any of the study medications,puts the patient at higher risk for treatment-related complications or may affectthe interpretation of study results.

20. Female patients, who are pregnant or breast feeding or planning to become pregnantwithin and 6 months after the end of treatment. Female patients of childbearingpotential must have a negative serum pregnancy test result within 7 days prior toinitiation of study treatment.