This phase Ib/II trial aims to evaluate the safety and preliminary efficacy of combining Trastuzumab Deruxtecan (T-DXd) with Azeliragon, a receptor for advanced glycation end products (RAGE) inhibitor in patients with T-DXd-resistant HER2-positive or HER2-low metastatic breast cancer at Houston Methodist Neal Cancer Center (HMNCC). Adults, 18 years of age or older, with histologically confirmed HER2-positive or HER2-low metastatic breast cancer with prior progression on T-DXd will be eligible to participate in the study.
Male or female ≥18 years of age at time of consent.
Written informed consent is required before performing any trial-specific tests or procedures. Signing of the informed consent form can occur outside the 28-day screening period.
Histologically confirmed HER2-positive or HER2-low or ultra low metastatic breast cancer.
Prior systemic progression in metastatic setting on T-DXd and have measurable disease per RECIST v1.1 Criteria.
Positive pregnancy test, pregnant, or breastfeeding for all women of child-bearing potential.
Per treating physician's assessment, any other clinically significant laboratory abnormality that would compromise patient safety or the outcome of the study.
Symptomatic valvular disease
Symptomatic congestive heart failure is classified by the New York Heart Association as Class III or IV
Sequential
Azeliragon
Drug* Starting Dose Level 1: Loading Dose for 6 Days is 15mg once daily; Maintenance Dose for days 7 and onward 5mg once daily * Dose level 2: Loading dose for 6 days is 15mg twice daily; maintenance dose for days 7 and onward is 10mg once daily * Dose level 3: Loading dose for 6 days is 30 mg twice daily; maintenance dose for days 7 and onward is 20mg once daily
T-DXd
Drug5.4 mg/kg IV q3w
RP2D of Azeligaron
Phase Ib (Dose Escalation): To assess the safety, tolerability (according to the NCI CTCAE (v6.0)) and to determine the RP2D of T-DXd plus a RAGE inhibitor (Azeliragon) in patients with T-DXd-resistant HER2-positive or HER2-low metastatic breast cancer.
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This trial is not recruiting at the moment. You can still explore other options:
