Overview

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.