CX-5461-HER2 Positive Solid Tumors and Breast Cancer
Study Focus
CX-5461-HER2 Positive Solid Tumors and Breast Cancer
Sponsor
National Cancer Institute (NCI)
Estimated Enrollment
36
Objective
Primary Endpoints:
1. Dose Escalation: Determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of CX-5461 in combination with T-DXd.
Eligible patient populations include:
HER2-positive solid tumors
HER2-low breast cancer
HR-positive breast cancers with HER2-positive/low/ultralow expression, or triple-negative HER2-low breast cancer
2. Dose Expansion: Evaluate safety and tolerability of CX-5461 combined with T-DXd at the RP2D in HER2-low and HR-positive HER2-ultralow breast cancer patients.
Secondary Endpoints:
1. Assess preliminary antitumor activity.
2. Evaluate pharmacokinetics (PK) of CX-5461 combined with T-DXd.
3. Collect tumor biopsies pre- and on-treatment during dose expansion to evaluate DNA damage response (DDR) biomarkers (pharmacodynamic targets).
