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Naxitamab and Sacituzumab Govitecan for Metastatic Triple-Negative Breast Cancer

This study is testing two drugs, naxitamab and sacituzumab govitecan, to see if they are safe, what the best dose is, and how well they work together for people with triple-negative breast cancer (TNBC) that has spread to other parts of the body (metastatic). You may be able to join if you are 18 or older, have metastatic TNBC, and meet other health requirements. The main goal is to understand the safety and side effects of this drug combination. This study is currently unclear about its recruitment status and plans to enroll 31 participants.

Study design
This is a Phase I/II interventional study, meaning it tests a new treatment in people. It plans to enroll 31 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety and side effects will be measured throughout the study, for an average of 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07011654

Study of Naxitamab and Sacituzumab Govitecan in Patients With Metastatic Triple-negative Breast Cancer (TNBC)

Recruiting
PHASE1Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~31 participants
Updated 2026-07-07 on ClinicalTrials.gov
What's tested:Sacituzumab govitecanNaxitamab

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and Adverse Events (AEs)
Measured over Through study completion; an average of 1 year

Conditions

Metastatic Triple-Negative Breast Cancer

Explore related trials

Breast Carcinoma

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Clinton Yam, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Akshara S Raghavendra
[email protected]
713-792-2817
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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 with this trial.
Received at least 1 prior line of systemic chemotherapy for metastatic TNBC and/or meet criteria to receive sacituzumab govitecan as standard of care
Measurable disease by CT or MRI as per RECIST Version 1.1 criteria
Adequate organ and marrow function as defined below:

Exclusion

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
Prior treatment with TROP2-targeting antibody drug conjugates in the metastatic setting. Participant s who have received TROP2-targeting antibody drug conjugates in the neoadjuvant setting or adjuvant setting are eligible if at least 6 months have elapsed since the last dose of TROP2-targeting antibody drug conjugate.
Have an active second malignancy. Participant s with a history of active cancer for 3 years prior to enrollment, or participant s with surgically cured tumors with low risk of recurrence (eg, nonmelanoma skin cancer, histologically confirmed complete excision of carcinoma in situ, or similar) are allowed to enroll.
Have known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
Have undergone an allogenic tissue or solid organ transplant.
Uncontrolled hypertension, defined as a consistently elevated systolic blood pressure of \>160 mmHg despite optimal medical management
Clinically significant cardiac disease
Inadequate pulmonary function
Active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or GI perforation within 6 months of enrollment.
Uncontrolled seizure disorders despite anticonvulsant therapy (defined as a seizure event within 3 months prior to enrollment)
Active serious infection requiring systemic antimicrobial therapy.
Participants positive for HIV-1 or 2 with a history of Kaposi sarcoma and/or Multicentric Castleman Disease.
Have active hepatitis B or C infection
Has a diagnosis of immunodeficiency or receiving systemic corticosteroid therapy (higher than physiologic doses) ≥ 10 mg of prednisone per day or equivalent\] or any other form of immunosuppressive therapy within 14 days of initiation of study treatment.
Has received prior radiotherapy within 1 weeks of start of study intervention.

What this trial measures

  • Safety and Adverse Events (AEs)Through study completion; an average of 1 year

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0