Study of Naxitamab and Sacituzumab Govitecan in Patients With Metastatic Triple-negative Breast Cancer (TNBC)

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

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.

Conditions3

Locations1 site

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