Study of Naxitamab and Sacituzumab Govitecan in Patients With Metastatic Triple-negative Breast Cancer (TNBC)
Phase I/II Study of Naxitamab and Sacituzumab Govitecan in Patients With Metastatic Triple-negative Breast Cancer (TNBC)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests naxitamab with sacituzumab govitecan for adults with triple-negative breast cancer that has spread to other parts of the body. It checks safety, finds the best dose, and tests how well the drugs work.
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).
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Age 18 or older, of any sex, and able to understand and sign a consent form.
- Able to do most daily tasks: an ECOG activity score of 0–1 for phase I or 0–2 for phase II.
- Expected to live at least 3 months.
- Triple-negative breast cancer confirmed by a tissue test that has spread to other parts of the body.
- Willing to provide a stored tumor tissue sample.
- Had at least one round of chemotherapy treatment for cancer that has spread, or qualify for sacituzumab govitecan as standard treatment.
- Cancer that can be measured on a CT or MRI scan.
- Organs and bone marrow, which makes blood cells, must work well enough.
Who can't join
- Pregnant or breastfeeding; known or severe allergy to either study drug or its ingredients; or severe nerve damage outside the brain and spinal cord.
- Past treatment with an anti-GD2 antibody. Past TROP2-targeting antibody-drug treatment for cancer that has spread also excludes you. Treatment before or after surgery is allowed if the last dose was at least 6 months ago.
- Another active cancer, with some exceptions for cancer history or tumors cured by surgery with a low risk of return; or active cancer in the brain, spinal cord, or their lining.
- Past tissue or solid organ transplant from a donor; serious heart disease; poor lung function; or blood pressure that stays above 160 for the top number despite treatment.
- Active long-term bowel inflammation, such as Crohn’s disease or ulcerative colitis; a hole in the stomach or bowel within 6 months; or seizures despite treatment within 3 months.
- A serious active infection needing medicine that works throughout the body; active hepatitis B or C; or HIV with a history of Kaposi sarcoma or Multicentric Castleman Disease.
- A condition that weakens the immune system, or recent medicines that suppress it. This includes prednisone at 10 mg daily or more, or a similar steroid dose, within 14 days before study treatment.
- Radiation treatment within 1 week before study treatment starts.
Simplified for readability. The official criteria below are what the study team uses.
Official 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.
Study sites (1)
TX
- The University of Texas M. D. Anderson Cancer Center · Houston, TX 77030Clinton Yam, MD · Study contact · 713-792-2817 · TNBC-NOW@mdanderson.orgClinton Yam, MD · Principal investigatorMore trials in Houston