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RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

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)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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).

Who May Be Eligible (Plain English)

Inclusion criteria - Male and female participants aged 18 years or older and able to understand and give written willing to sign a consent form - Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 (for the phase I portion of the study) and You should be able to carry out daily activities with 0 level of ability (ECOG 0)-2 (for the phase II portion of the study) - expected to live at least 3 months - diagnosed by tissue sample (biopsy-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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

Sacituzumab govitecan

Given by IV

DRUG

Naxitamab

Given by IV

Locations (1)

The University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States