RecruitingPhase 2

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

A Phase II Clinical Trial of Neoadjuvant Zanidatamab for HER2+ Localized Colorectal Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 2 years
  • Procedures mentioned: Blood draws, MRI scans, CT scans, Biopsies

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Additionally, patients undergo echocardiography or multigated acquisition (MUGA) scan, sigmoidscopy, computed tomography (CT) or magnetic resonance imaging (MRI), and blood sample collection throughout the study."
  • "Patients also undergo archival tissue sample collection or biopsy during screening."
  • "Additionally, patients undergo echocardiography or MUGA scan, sigmoidscopy, CT, MRI, blood sample collection, and digital rectal exam throughout the study."
  • "After completion of study treatment, patients are followed up at 30 days and then every 12 weeks for up to 2 years."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests zanidatamab before surgery for adults with HER2-positive colon or rectal cancer who plan to get treatment aimed at a cure. HER2 is a protein that can help cancer grow. Zanidatamab is a protein-based drug that may stop cancer cells from growing and spreading.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older, with colon or rectal cancer confirmed by tissue or cell tests. Plan to get treatment aimed at a cure at Emory's Winship Cancer Institute or a partner center.
  • The tumor must test HER2-positive and have no RAS gene changes.
  • The cancer must be measurable on scans.
  • Be able to care for yourself and be out of bed or a chair for at least half of your waking hours.
  • Blood counts and liver and kidney tests must meet study limits. A heart test must show that the heart pumps out at least 50% of the blood in its main pumping chamber.
  • If you can become pregnant, have a negative pregnancy test before treatment.
  • Men and women who can become pregnant must agree to use birth control or avoid sex before and during the study, and for 3 months after the last study drug dose.
  • Sign a consent form and agree to study visits, treatment, tests, required blood draws, and other study rules.

Who can't join

  • Stage IV cancer, meaning cancer that has spread to distant parts of the body, even if surgery aimed at a cure is planned.
  • A tumor that does not meet the study's HER2-positive test rules, or that has a RAS gene change.
  • Rectal cancer with MSI-H or mismatch repair deficiency, meaning certain problems with how cancer cells repair their DNA.
  • Serious heart disease, such as a heart rhythm problem needing treatment, uncontrolled high blood pressure, or past heart failure with symptoms. Past heart failure caused by cancer treatment must have been mild and fully resolved.
  • A heart attack or unstable chest pain within 6 months before the planned first treatment.
  • Use of another experimental drug or device within 28 days before the first study dose.
  • Past allergic reactions to drugs similar to the study drug.
  • An uncontrolled illness, such as an active infection, or a mental health condition or social situation that would make it hard to follow study rules.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Study sites (4)

GA