Study of IMMU-132 in HR+/HER2- MBC (TROPICS-02)

Open to people ages 18 years and up

• Female or male subjects aged ≥18 years at the time of signing the informed consent form
• Documented evidence of hormone receptor-positive HER2-negative (HR+/HER2-) MBC confirmed
• Refractory to or relapsed after at least 2, and no more than 4, prior systemic chemotherapy regimens for MBC including:
• At least 1 prior anticancer hormonal treatment.
• At least 1 cyclin-dependent kinase inhibitor 4/6 in the metastatic setting.
• Eligible for one of the chemotherapy options listed in the TPC arm
• Documented disease progression after the most recent therapy
• Adequate bone marrow function (hemoglobin > 9 g/dL, ANC > 1,500 per mm3, platelets > 100,000 per mm3).
• Adequate renal function: calculated creatinine clearance ≥30 mL/minute according to the Cockcroft and Gault formula
• Adequate hepatic function (bilirubin ≤ 1.5 IULN, AST and ALT ≤ 2.5 x IULN or 5.0 x IULN)
• Females must not be lactating or pregnant at Screening or Baseline (as documented by a negative beta human chorionic gonadotropin [ß-hCG]

• Previous treatment with Topoisomerase 1 Inhibitors as a free form or as other formulations
• History of significant cardiovascular disease or clinically significant ECG abnormality
• Patients with Gilbert's disease.
• Active infection requiring intravenous antibiotic use
• Patients with a history of an anaphylactic reaction to irinotecan.
• Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.
• Locally advanced MBC (stage IIIc) in subjects who are candidates for curative intent therapy at the time of study enrollment