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

NCT07405476 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2026-04-17

No results posted yet for this study

Summary

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).

Conditions

  • 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

Interventions

BIOLOGICAL

Zanidatamab

Given IV

PROCEDURE

Resection

Undergo surgical resection

OTHER

Patient Observation

Undergo observation

PROCEDURE

Echocardiography Test

Undergo echocardiography

PROCEDURE

Multigated Acquisition Scan

Undergo MUGA scan

PROCEDURE

Endoscopic Procedure

Undergo sigmoidscopy

PROCEDURE

Computed Tomography

Undergo CT

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

PROCEDURE

Biospecimen Collection

Undergo blood and/or archival tissue sample collection

PROCEDURE

Biopsy Procedure

Undergo biopsy

PROCEDURE

Digital Rectal Examination

Undergo digital rectal examination

OTHER

Electronic Health Record Review

Ancillary studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Emory University

    lead OTHER

Principal Investigators

  • Olumide B. Gbolahan, MBBS, MSc · Emory University Hospital/Winship Cancer Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-07
Primary Completion
2028-12-18
Completion
2029-12-18
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT07405476 on ClinicalTrials.gov