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NCT07011654Toboroz1/2. fázis

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)

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. júl. 7.

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Rövid összefoglaló (regiszter, angolul)

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).

Állapot (regiszter)
Toboroz
Fázis (regiszter)
1/2. fázis
Vizsgálattípus
Beavatkozással járó
Résztvevők száma
31 (tervezett)
Első benyújtás
2025. máj. 30.
Kezdés
2025. szept. 19.
Elsődleges befejezés
2028. júl. 1.
Fő szponzor
M.D. Anderson Cancer Center
NCT-szám
NCT07011654

Mit vállalsz

  • Vizsgálat típusa: Beavatkozással járó · 1/2. fázis
  • Tervezett résztvevők: 31
  • 2025. szept. 19. és az elsődleges befejezés (2028. júl. 1.) között
  • 1 helyszín, 1 országban
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

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Kiket keres a vizsgálat

  • 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:
    • 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.

Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (1)

Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.

HelyszínVárosOrszágHelyszín állapota
The University of Texas M. D. Anderson Cancer CenterHoustonEgyesült ÁllamokToboroz

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