Metastatic Triple-Negative Breast CancerPhase 1/2NCT07011654
Study of Naxitamab and Sacituzumab Govitecan in Patients With Metastatic Triple-negative Breast Cancer (TNBC)
A Phase 1/2 study testing Sacituzumab govitecan and Naxitamab in people with Metastatic Triple-Negative Breast Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Triple-Negative Breast Cancer
- What is being tested?
- Sacituzumab govitecan and Naxitamab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Sep 2025to 1 Jul 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 27Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030
Clinton Yam, MD, 713-792-2817, TNBC-NOW@mdanderson.org
Clinton Yam, MD
About this study
Official title: Phase I/II Study of Naxitamab and Sacituzumab Govitecan in Patients With Metastatic Triple-negative Breast Cancer (TNBC)
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).
Read the detailed description
- Primary Objectives
- To determine the safety and tolerability and establish the maximum tolerated dose/recommended phase 2 dose (MTD/RP2D) of the combination of naxitamab and sacituzumab govitecan in participant s with metastatic TNBC.
- To determine the objective response rate (ORR) of naxitamab in combination with sacituzumab govitecan per RECIST v1.1 criteria in participant s with metastatic TNBC at the MTD/RP2D.
- Secondary Objectives
- To determine the duration of response, progression-free survival, and overall survival for participant s with metastatic TNBC treated with the combination of naxitamab plus SG:
- To identify GD2-related biomarkers of response and resistance to the combination of naxitamab and sacituzumab govitecan.
- Exploratory/Correlative Objectives • Investigate potential resistance mechanisms to naxitamab and develop a pre-clinical rationale for future therapeutic strategies.
- Conditions
- Metastatic Triple-Negative Breast Cancer
- Being tested
- Sacituzumab govitecan, Naxitamab
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacituzumab govitecanDrug
Given by IV
NaxitamabDrug
Given by IV
| Study group | Role | What they receive |
|---|---|---|
| Treatment with Naxitamab and Sacituzumab Govitecan IV Q3W | Experimental | Patients receive naxitamab IV on days 2, 4, and 6 of cycles 1-8 and sacituzumab govitecan IV days 1 and 8 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: Sacituzumab govitecan; Drug: Naxitamab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2025
- Study start19 Sep 2025
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Triple-Negative Breast CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Y-mAbs Therapeutics
- Responsible party
- Sponsor
- Investigators
- Clinton Yam, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07011654
- Sponsor's protocol ID
- 2025-0438
- Other IDs
- NCI-2025-03798
- Status last verified
- Jul 2026
- First submitted
- 30 May 2025
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of Naxitamab and Sacituzumab Govitecan in Patients With Metastatic Triple-negative Breast Cancer (TNBC)
- ClinicalTrials.gov ID
- NCT07011654
- Acronym / sponsor ID
- 2025-0438
- Conditions
- Metastatic Triple-Negative Breast Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Y-mAbs Therapeutics
- Study start
- 19 Sep 2025 (actual)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jul 2030 (estimated)
- First posted
- 9 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
- Primary Objectives
- To determine the safety and tolerability and establish the maximum tolerated dose/recommended phase 2 dose (MTD/RP2D) of the combination of naxitamab and sacituzumab govitecan in participant s with metastatic TNBC.
- To determine the objective response rate (ORR) of naxitamab in combination with sacituzumab govitecan per RECIST v1.1 criteria in participant s with metastatic TNBC at the MTD/RP2D.
- Secondary Objectives
- To determine the duration of response, progression-free survival, and overall survival for participant s with metastatic TNBC treated with the combination of naxitamab plus SG:
- To identify GD2-related biomarkers of response and resistance to the combination of naxitamab and sacituzumab govitecan.
- Exploratory/Correlative Objectives • Investigate potential resistance mechanisms to naxitamab and develop a pre-clinical rationale for future therapeutic strategies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with Naxitamab and Sacituzumab Govitecan IV Q3W | Experimental | Drug: Sacituzumab govitecan, Drug: NaxitamabPatients receive naxitamab IV on days 2, 4, and 6 of cycles 1-8 and sacituzumab govitecan IV days 1 and 8 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sacituzumab govitecanGiven by IV | Drug | Treatment with Naxitamab and Sacituzumab Govitecan IV Q3W |
| NaxitamabGiven by IV | Drug | Treatment with Naxitamab and Sacituzumab Govitecan IV Q3W |
Primary outcome
Safety and Adverse Events (AEs)
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clinton Yam, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Sacituzumab govitecan and Naxitamab in people with Metastatic Triple-Negative Breast Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 27 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Akshara S Raghavendra (713-792-2817, TNBC-NOW@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Adverse Events (AEs) (time frame: Through study completion; an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.