OncoMatch/Clinical Trials/NCT06695845
A Phase 2 Study of Zanidatamab in Patients With HER2-expressing Tumors
Is NCT06695845 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies Zanidatamab for breast cancer.
Treatment: Zanidatamab — The purpose of this study is to evaluate the efficacy and safety of zanidatamab for the treatment of participants with previously treated solid tumors that have Human Epidermal Growth Factor Receptor 2 (HER2) Immunohistochemistry (IHC) 3+ overexpression.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Cancer type
Breast Carcinoma
Gastric Cancer
Esophageal Carcinoma
Colorectal Cancer
Endometrial Cancer
Non-Small Cell Lung Carcinoma
Ovarian Cancer
Urothelial Carcinoma
Head and Neck Squamous Cell Carcinoma
Pancreatic Cancer
Biomarker criteria
Required: HER2 (ERBB2) overexpression (IHC 3+)
HER2 overexpression (IHC 3+) must be determined by a sponsor designated central laboratory
Required: KRAS mutation
Colorectal Cancer (CRC) participants with known KRAS/NRAS and BRAF mutations [excluded]
Required: NRAS mutation
Colorectal Cancer (CRC) participants with known KRAS/NRAS and BRAF mutations [excluded]
Required: BRAF mutation
Colorectal Cancer (CRC) participants with known KRAS/NRAS and BRAF mutations [excluded]
Required: ALK mutation
Non-Small Cell Lung Cancer (NSCLC) participants with known ALK, EGFR mutations and ROS1 fusion [excluded]
Required: EGFR mutation
Non-Small Cell Lung Cancer (NSCLC) participants with known ALK, EGFR mutations and ROS1 fusion [excluded]
Required: ROS1 fusion
Non-Small Cell Lung Cancer (NSCLC) participants with known ALK, EGFR mutations and ROS1 fusion [excluded]
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: HER2-targeted therapy
Exception: Cohort 1 only
Prior treatment with HER2-targeted therapy is not permitted (Cohort 1 only)
Cannot have received: HER2-targeted therapy
Prior treatment with HER2-targeted therapy (Cohort 1 only) [excluded]
Cannot have received: trastuzumab deruxtecan (trastuzumab deruxtecan)
prior therapy with trastuzumab deruxtecan (T-DXd) is required [for breast cancer (Cohort 2) or GEA (Cohort 3)]
Cannot have received: zanidatamab (zanidatamab)
Received zanidatamab at any time prior to the current study
Lab requirements
Blood counts
Kidney function
Liver function
Adequate organ functions.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Arizona Oncology Associates, PC - NAHOA · Prescott, Arizona
- Rocky Mountain Cancer Center · Littleton, Colorado
- Florida Cancer Specialists - South · Fort Myers, Florida
- Florida Cancer Specialists - Lake Nona · Orlando, Florida
- Florida Cancer Specialists - North · St. Petersburg, Florida
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06695845 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior HER2-targeted therapy, HER2-targeted therapy, trastuzumab deruxtecan disqualifies patients from enrollment.
Does this trial require ERBB2?
Yes, ERBB2 overexpression is a required biomarker for enrollment.
Does this trial require KRAS?
Yes, KRAS mutation is a required biomarker for enrollment.
Does this trial require NRAS?
Yes, NRAS mutation is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify