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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Sacituzumab govitecan
DrugGiven by IV
Naxitamab
DrugGiven by IV
Treatment groups
31 Participants
are divided into 1 treatment groupGroup A: Treatment with Naxitamab and Sacituzumab Govitecan IV Q3WExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Safety and Adverse Events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Time frame
Through study completion; an average of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
M.D. Anderson Cancer Center
Lead sponsor
Y-mAbs Therapeutics
Collaborator
Source ClinicalTrials.gov