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Study of Trastuzumab Deruxtecan (T-DXd) in Combination With a RAGE Inhibitor in Patients With T-DXd-Resistant HER2-Positive or HER2-Low Metastatic Breast Cancer

NCT07785856 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2026-08-25

No results posted yet for this study

Summary

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.

Conditions

  • T-dxd Resistant HER2-Positive
  • HER2 Low Metastatic Breast Cancer

Interventions

DRUG

Azeliragon

* 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

DRUG

T-DXd

5.4 mg/kg IV q3w

Sponsors & Collaborators

  • The Methodist Hospital Research Institute

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-12-31
Primary Completion
2028-12-31
Completion
2029-12-31
FDA Drug
Yes

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07785856 on ClinicalTrials.gov