NCT07011654 Study of Naxitamab and Sacituzumab Govitecan in Patients With Metastatic Triple-negative Breast Cancer (TNBC)
| NCT ID | NCT07011654 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | M.D. Anderson Cancer Center |
| Condition | Metastatic Triple-Negative Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 31 participants |
| Start Date | 2025-09-19 |
| Primary Completion | 2028-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 31 participants in total. It began in 2025-09-19 with a primary completion date of 2028-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Clinton Yam, MD
PRINCIPAL INVESTIGATOR
M.D. Anderson Cancer Center
Frequently Asked Questions
Who can join the NCT07011654 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Metastatic Triple-Negative Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07011654 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07011654 currently recruiting?
Yes, NCT07011654 is actively recruiting participants. Contact the research team at TNBC-NOW@mdanderson.org for enrollment information.
Where is the NCT07011654 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT07011654 clinical trial?
NCT07011654 is sponsored by M.D. Anderson Cancer Center. The principal investigator is Clinton Yam, MD at M.D. Anderson Cancer Center. The trial plans to enroll 31 participants.
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