Health TrialsbyHealthPanel

Zanidatamab Before Surgery for the Treatment of HER2 Positive Colon and Rectal Cancer in Patients Planned for Curative Intent Treatment

ConditionsColon CarcinomaColorectal CarcinomaRectal CarcinomaStage I Colon Cancer AJCC v8Stage I Colorectal Cancer AJCC v8Stage I Rectal Cancer AJCC v8Stage II Colon Cancer AJCC v8Stage II Colorectal Cancer AJCC v8Stage II Rectal Cancer AJCC v8Stage III Colon Cancer AJCC v8Stage III Colorectal Cancer AJCC v8Stage III Rectal Cancer AJCC v8
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorEmory University

About this trial

This phase II trial studies how well giving zanidatamab before surgery (neoadjuvant) works in treating patients with colon and rectal cancer that is human epidermal growth factor receptor 2 positive (HER2+ve) who are planned for curative intent treatment. Zanidatamab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Zanidatamab

    Biological/Vaccine

    Given IV

  • Resection

    Procedure/Surgery

    Undergo surgical resection

  • Patient Observation

    Other intervention

    Undergo observation

  • Echocardiography Test

    Procedure/Surgery

    Undergo echocardiography

  • Multigated Acquisition Scan

    Procedure/Surgery

    Undergo MUGA scan

  • Endoscopic Procedure

    Procedure/Surgery

    Undergo sigmoidscopy

  • Computed Tomography

    Procedure/Surgery

    Undergo CT

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo MRI

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood and/or archival tissue sample collection

  • Biopsy Procedure

    Procedure/Surgery

    Undergo biopsy

  • Digital Rectal Examination

    Procedure/Surgery

    Undergo digital rectal examination

  • Electronic Health Record Review

    Other intervention

    Ancillary studies

Treatment groups

38 Participants
are divided into 2 treatment groups
Group A: Cohort 1 (zanidatamab, surgical resection)Experimental treatment 12 interventions
Group B: Cohort 2 (zanidatamab)Experimental treatment 12 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
At time of surgical resection
2

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.

Time frame
At 6 and 12 weeks
3

Tumor Regression Grades (Cohort 2)

Will be assessed in those who undergo surgical resection.

Time frame
At time of surgical resection

Secondary outcomes

1

Rate of Circulating Tumor Deoxyribonucleic Acid Clearance

Time frame
Before cycle 1 day 1 of treatment and preoperatively for colon cancer patients or at 6 and 12 weeks for rectal cancer patients
2

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.

Time frame
At 2 years
3

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.

Time frame
At 2 years
4

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.

Time frame
Up to 30 days post-discontinuation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Emory University

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
Apply now