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

Status: Active

Description

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.

Eligibility 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 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]

Exclusion Criteria

  • 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

Locations & Contacts

California

Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: In review
Contact: Sarah Rosales
Phone: 310-794-7686
Email: srosales@mednet.ucla.edu
San Francisco
UCSF Medical Center-Mount Zion
Status: Active
Contact: Helen Diller Family Comprehensive Cancer Center
Phone: 877-827-3222
Email: cancertrials@ucsf.edu

Colorado

Aurora
University of Colorado Hospital
Status: Active
Name Not Available

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: In review
Name Not Available

New Jersey

New Brunswick
Rutgers Cancer Institute of New Jersey
Status: In review
Name Not Available

New York

New York
Icahn School of Medicine at Mount Sinai
Status: Active
Name Not Available
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: Active
Name Not Available

Ohio

Columbus
Ohio State University Comprehensive Cancer Center
Status: In review
Name Not Available

Pennsylvania

Philadelphia
Thomas Jefferson University Hospital
Status: Approved
Name Not Available
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: Active
Name Not Available

Texas

San Antonio
Cancer Therapy and Research Center at The UT Health Science Center at San Antonio
Status: In review
Contact: Virginia G. Kaklamani
Phone: 210-450-3838
Email: kaklamani@uthscsa.edu

Trial Objectives and Outline

Approximately 400 eligible subjects will be randomized to one of the following 2 treatment arms: Investigational Arm: Sacituzumab Govitecan 10 mg/kg via IV injection administered on Day 1 and Day 8 (21-day cycle). Control Arm: Recommended doses and schedules as per NCCN guidelines (with dose modifications if too toxic). Eribulin; Capecitabine; Gemcitabine; Vinorelbine

Trial Phase & Type

Trial Phase

Phase III

Trial Type

Treatment

Lead Organization

Lead Organization
Immunomedics Inc

Trial IDs

Primary ID IMMU-132-09
Secondary IDs NCI-2019-03005
Clinicaltrials.gov ID NCT03901339