Asian Study of Sacituzumab Govitecan (IMMU-132) in HR+/HER2- MBC

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label, randomized, multicenter Phase 3 study to compare the efficacy and safety of sacituzumab govitecan versus TPC in subjects with metastatic or locally recurrent inoperable HR+/HER2- MBC, after failure of at least 2, and no more than 4, prior chemotherapy regimens for metastatic disease.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Everest Medicines
• Collaborators: Iqvia Pty Ltd; Medidata Solutions; Parexel
• Treatments: Capecitabine; Gemcitabine; Vinorelbine

Criteria

Inclusion Criteria:

• 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

• Should have been previously treated with at least 1 taxane in any setting, at least 1 prior anticancer hormonal treatment in any setting

• Eligible for one of the chemotherapy options listed in the TPC arm

• Documented radiographic disease progression after the most recent therapy

• Measurable disease by CT or MRI in accordance with RECIST v 1.1, bone-only disease is not measurable and is not permitted.

• Adequate bone marrow function, hepatic and renal function

• Females must not be lactating or pregnant at Screening or Baseline (as documented by a negative beta human chorionic gonadotropin [ß-hCG]

Exclusion Criteria:

• Previous treatment with Topoisomerase 1 Inhibitors as a free form or as other formulations

• Subjects who have known brain metastases.

• Have an active second malignancy within 3 years prior to providing informed consent

• Subjects with active hepatitis B virus (HBV), or hepatitis C virus infection (measurable viral RNA load with polymerase chain reaction).

• Active serious infection requiring systemic antibiotic use within 7 days before C1D1.

• 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.

• Known hypersensitivity or intolerance to either of the study treatments or any of the excipients.