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Clinical Trial NCT07405476 for Colon Carcinoma, Colorectal Carcinoma, Rectal Carcinoma, Stage I Colon Cancer AJCC v8, Stage I Colorectal Cancer AJCC v8, Stage I Rectal Cancer AJCC v8, Stage II Colon Cancer AJCC v8, Stage II Colorectal Cancer AJCC v8, Stage II Rectal Cancer AJCC v8, Stage III Colon Cancer AJCC v8, Stage III Colorectal Cancer AJCC v8, Stage III Rectal Cancer AJCC v8 is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
Emory UniversityZanidatamab Before Surgery for the Treatment of HER2 Positive Colon and Rectal Cancer in Patients Planned for Curative Intent Treatment Phase 2 38 Monoclonal Antibody
I. To determine the activity of neoadjuvant zanidatamab in HER2+ve (RAS wild type \[RAS WT\]) locally advanced colorectal cancer.
SECONDARY OBJECTIVES:
I. To determine the efficacy of neoadjuvant zanidatamab in HER2+ve (RAS WT) locally advanced colorectal cancer.
II. To determine the feasibility and safety of neoadjuvant zanidatamab in human epidermal growth factor receptor 2 positive (HER2+) l...
Show MoreA Phase II Clinical Trial of Neoadjuvant Zanidatamab for HER2+ Localized Colorectal Cancer
- 2025P012862
- WINSHIP6609-25 (Other Identifier) (Emory University Hospital/Winship Cancer Institute)
- NCI-2026-00566 (Registry Identifier) (Clinical Trials Reporting Program)
- P30CA138292 (U.S. NIH Grant/Contract)
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalCohort 1 (zanidatamab, surgical resection) Patients receive zanidatamab IV over 90-150 minutes on day 1 of each cycle. Cycles repeat every 14 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo surgical resection on study followed by adjuvant chemotherapy as per standard of care. Additionally, patients undergo echocardiography or MUGA scan, sigmoidscopy, CT or MRI, and blood sample collection throughou...Show More | Zanidatamab Given IV Resection Undergo surgical resection Patient Observation Undergo observation Echocardiography Test Undergo echocardiography Multigated Acquisition Scan Undergo MUGA scan Endoscopic Procedure Undergo sigmoidscopy Computed Tomography Undergo CT Magnetic Resonance Imaging Undergo MRI Biospecimen Collection Undergo blood and/or archival tissue sample collection Biopsy Procedure Undergo biopsy Digital Rectal Examination Undergo digital rectal examination Electronic Health Record Review Ancillary studies |
ExperimentalCohort 2 (zanidatamab) Patients receive zanidatamab IV over 90-150 minutes on day 1 of each cycle. Cycles repeat every 14 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients then optionally undergo surgical resection or observation as per standard of care. Additionally, patients undergo echocardiography or MUGA scan, sigmoidscopy, CT, MRI, blood sample collection, and digital rectal exam throug...Show More | Zanidatamab Given IV Resection Undergo surgical resection Patient Observation Undergo observation Echocardiography Test Undergo echocardiography Multigated Acquisition Scan Undergo MUGA scan Endoscopic Procedure Undergo sigmoidscopy Computed Tomography Undergo CT Magnetic Resonance Imaging Undergo MRI Biospecimen Collection Undergo blood and/or archival tissue sample collection Biopsy Procedure Undergo biopsy Digital Rectal Examination Undergo digital rectal examination Electronic Health Record Review Ancillary studies |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Rate of Complete and Major Pathologic Regression (Cohort 1) | For colon cancer, will evaluate the rate of complete and major pathologic regression in the surgical specimen based on the modified Dworak grading system. Will be reported as a proportion, and 95% exact binomial confidence interval. Will be estimated using the Clopper-Pearson method. | At time of surgical resection |
Radiologic Response (Cohort 2) | Assessment will be by computed tomography chest, abdomen and magnetic resonance imaging of the rectum. Radiologic tumor response will be based on Response Evaluation Criteria in Solid Tumors 1.1. Will be reported as a proportion, and 95% exact binomial confidence interval. Will be estimated using the Clopper-Pearson method. | At 6 and 12 weeks |
Tumor Regression Grades (Cohort 2) | Will be assessed in those who undergo surgical resection. | At time of surgical resection |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Rate of Circulating Tumor Deoxyribonucleic Acid Clearance | Before cycle 1 day 1 of treatment and preoperatively for colon cancer patients or at 6 and 12 weeks for rectal cancer patients | |
Rate of Tumor Recurrence | Will be estimated using the Kaplan-Meier method, and a 95% confidence interval for median will be estimated using the Brookmeyer-Crowley approach. | At 2 years |
Recurrence Free Survival | Will be estimated using the Kaplan-Meier method, and a 95% confidence interval for median will be estimated using the Brookmeyer-Crowley approach. | At 2 years |
Incidence of Adverse Events | Safety will be determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5. Frequencies and percentages will be used to summarize safety events. | Up to 30 days post-discontinuation |
Proportion of Subjects who Complete Four Treatment Cycles (Feasibility) | Frequencies and percentages will be used to summarize events. | Up to 3 years |
Adverse Even Profile (Feasibility) | Frequencies and percentages will be used to summarize events. | Up to 3 years |
Rate of Perioperative Complications (Feasibility) | Frequencies and percentages will be used to summarize events. | Up to 3 years |
Histologically or cytologically confirmed colon and/or rectal cancer planned for curative intent treatment at gastrointestinal clinics of Emory University's Winship Cancer Institute and collaborating centers
Tumors must be HER2+ve (human epidermal growth factor receptor 2 \[HER2\] overexpression 3+ immunohistochemistry \[IHC\] or 2+ by IHC and positive fluorescence in situ hybridization \[FISH\] or HER2 amplification by next generation sequencing)
Tumors must have RAS wildtype genotype
Radiologically measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Age ≥ 18 years
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 50%)
Platelet count > 100,000 cells/ ul (within 28 days of cycle 1 day 1, at the discretion of the investigator)
Hemoglobin > 9g/dl (within 28 days of cycle 1 day 1, at the discretion of the investigator)
Absolute neutrophil count > 1000 cells/dl (within 28 days of cycle 1 day 1, at the discretion of the investigator)
Aspartate aminotransferase (AST) ≤ 3 × upper limit of normal (ULN) (within 28 days of cycle 1 day 1, at the discretion of the investigator)
Alanine aminotransferase (ALT) ≤ 3 × ULN (within 28 days of cycle 1 day 1, at the discretion of the investigator)
Total bilirubin ≤ 1.5 × ULN, or ≤ 3 × ULN for participants with Gilbert's disease (within 28 days of cycle 1 day 1, at the discretion of the investigator)
Glomerular filtration rate (GFR) > 60ml/min (based on creatine, and Cystatin C estimation where applicable) (within 28 days of cycle 1 day 1, at the discretion of the investigator)
Adequate cardiac function with left ventricular ejection fraction of at least 50% (within 28 days of cycle 1 day 1, at the discretion of the investigator)
Females of child-bearing potential (FCBP) must have a negative serum or urine pregnancy test prior to starting therapy
FCBP and men treated or enrolled on this protocol must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and 3 months after completion of study drug administration. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
* A female of childbearing potential (FCBP) is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
Willingness and ability of the subject to comply with scheduled visits, drug administration plan, protocol-specified laboratory tests, other study procedures, and study restrictions. This includes willingness to undergo mandatory blood sample draws for evaluation of correlatives
Evidence of a personally signed informed consent indicating that the subject is aware of the neoplastic nature of the disease and has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation.
- Participants with stage IV colon and rectal cancer even if curative intent resection is planned
- HER2 expression that does not meet documented inclusion criteria
- RAS mutation
- MSI-H or mismatch repair deficient rectal cancer
- Clinically significant cardiac disease, such as ventricular arrhythmia requiring therapy, uncontrolled hypertension or any history of symptomatic congestive heart failure (CHF). Participants with known myocardial infarction or unstable angina within 6 months prior to expected date of cycle 1 day 1 (C1D1) are also excluded. Previous anticancer therapy-related CHF must have been ≤ grade 1 at the time of occurrence and must have completely resolved
- Participants receiving any other investigational agents or an investigational device within 28 days of administering the first dose of study drug
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to the agents used in study
- Uncontrolled current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
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