Phase I/II Study of Naxitamab and Sacituzumab Govitecan in Patients With Metastatic Triple-negative Breast Cancer (TNBC)
M.D. Anderson Cancer Center
Summary
This phase I/II trial tests the safety, best dose, and effectiveness of naxitamab in combination with sacituzumab govitecan in treating patients with triple-negative breast cancer (TNBC) that has spread from where it first started (primary site) to other places in the body (metastatic).
Description
1. Primary Objectives * To determine the safety and tolerability and establish the maximum tolerated dose/recommended phase 2 dose (MTD/RP2D) of the combination of naxitamab and sacituzumab govitecan in participant s with metastatic TNBC. * To determine the objective response rate (ORR) of naxitamab in combination with sacituzumab govitecan per RECIST v1.1 criteria in participant s with metastatic TNBC at the MTD/RP2D. 2. Secondary Objectives * To determine the duration of response, progression-free survival, and overall survival for participant s with metastatic TNBC treated with t…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion criteria * Male and female participants aged 18 years or older and able to understand and give written informed consent * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 (for the phase I portion of the study) and ECOG performance status of 0-2 (for the phase II portion of the study) * Life expectancy of at least 3 months * Histologically confirmed metastatic TNBC. (Estrogen receptor \[ER\] ≤10%; Progesterone receptor \[PgR\] ≤10%, HER2-negative as per ASCO/CAP guidelines) * Willingness to provide archival tumor tissue for correlative studies associated w…
Interventions
- DrugSacituzumab govitecan
Given by IV
- DrugNaxitamab
Given by IV
Location
- The University of Texas M. D. Anderson Cancer CenterHouston, Texas