New drug duo takes on tough breast cancer
NCT ID NCT07011654
First seen Jun 27, 2026 · Last updated Jul 08, 2026 · Updated 2 times
Summary
This early-phase trial is testing whether combining two drugs, naxitamab and sacituzumab govitecan, is safe and effective for people with metastatic triple-negative breast cancer. The study aims to find the best dose and check for side effects in 31 adults whose cancer has spread. If successful, this could offer a new treatment option for a hard-to-treat cancer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- naxitamab and sacituzumab govitecan
- What this could lead to
- If it works, this could point toward a new combination treatment for metastatic triple-negative breast cancer that may help shrink tumors or slow disease progression.
- What could go wrong
- This is an early-phase trial with only 31 participants, so results may not apply to all patients. The combination may cause side effects or not work better than existing treatments.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 31 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Jul 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 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: 2\. Exclusion Criteria Participants who meet any of the following exclusion criteria are not eligible to be enrolled in this study. * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The University of Texas M. D. Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
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