Actively Recruiting
Study of Naxitamab and Sacituzumab Govitecan in Patients With Metastatic Triple-negative Breast Cancer (TNBC)
Led by M.D. Anderson Cancer Center · Updated on 2026-04-16
31
Participants Needed
1
Research Sites
249 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
Y
Y-mAbs Therapeutics
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Study of Naxitamab and Sacituzumab Govitecan in Patients With Metastatic Triple-negative Breast Cancer (TNBC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female participants aged 18 years or older able to understand and provide written informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 for phase I and 0 to 2 for phase II
- Life expectancy of at least 3 months
- Histologically confirmed metastatic triple-negative breast cancer (ER ≤10%, PgR ≤10%, HER2-negative)
- Willingness to provide archival tumor tissue for correlative studies
- Received at least one prior line of systemic chemotherapy for metastatic TNBC or eligible for sacituzumab govitecan as standard care
- Measurable disease by CT or MRI according to RECIST Version 1.1 criteria
- Adequate organ and marrow function as defined by the study
You will not qualify if you...
- Positive pregnancy test or currently lactating
- Known or severe (Grade 3 or higher) allergy to naxitamab or sacituzumab govitecan
- Grade 3 or greater peripheral neuropathy
- Previous treatment with anti-GD2 antibodies
- Prior TROP2-targeting antibody drug conjugates in the metastatic setting; prior neoadjuvant or adjuvant use allowed if at least 6 months since last dose
- Active second malignancy, except for low-risk tumors or those cured surgically
- Known active central nervous system metastases or carcinomatous meningitis
- History of allogenic tissue or solid organ transplant
- Uncontrolled hypertension (systolic BP >160 mmHg despite treatment)
- Clinically significant heart disease
- Inadequate lung function
- Active chronic inflammatory bowel disease or recent gastrointestinal perforation within 6 months
- Uncontrolled seizure disorders within 3 months prior to enrollment
- Active serious infections requiring systemic antibiotics
- HIV positive with history of Kaposi sarcoma or Multicentric Castleman Disease
- Active hepatitis B or C infection
- Diagnosed immunodeficiency or receiving immunosuppressive therapy (including corticosteroids >10 mg prednisone daily) within 14 days before treatment
- Radiation therapy within 1 week before starting study treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
A
Akshara S Raghavendra
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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