NCT07011654

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)

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 31 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

1. 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. 2. 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. 3. 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

Interventions

Type	Name	Description
DRUG	Sacituzumab govitecan	Given by IV
DRUG	Naxitamab	Given by IV

Timeline

• Start date: 2025-09-19
• Primary completion: 2028-07-01
• Completion: 2030-07-01
• First posted: 2025-06-09
• Last updated: 2026-04-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study