Study of Naxitamab and Sacituzumab Govitecan in Patients With Metastatic Triple-negative Breast Cancer (TNBC)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center
About this trial
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).
Eligibility criteria
Qualifiers
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)
Disqualifiers
Positive serum pregnancy test or women who are lactating.
Known or severe (≥ Grade 3) hypersensitivity or allergy to naxitamab and/or sacituzumab govitecan, their metabolites, or formulation excipient.
Grade 3 or greater peripheral neuropathy
Have previously received treatment with an anti-GD2 antibody
Trial design
Treatments tested in this trial
- Sacituzumab govitecan
- Naxitamab
Treatment groups
31 Participants
are divided into 1 treatment groupSponsors and collaborators
M.D. Anderson Cancer Center
Lead sponsor
Y-mAbs Therapeutics
Collaborator
Source ClinicalTrials.gov