Phase 2 Colorectal Cancer Trial, Recruiting NCT07405476 Sponsor: Emory University Condition: Colorectal Cancer
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Phase 2 Colorectal Cancer Trial, Recruiting

NCT07405476
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have been diagnosed with colon and/or rectal cancer (confirmed by a lab test) and your doctors are planning to treat it with the goal of curing it at Emory University's Winship Cancer Institute or a partner center
  • Your tumor tests positive for a protein called HER2, confirmed through specific lab testing methods
  • Your tumor has a specific genetic profile called "RAS wildtype" (meaning no RAS gene mutation is present)
  • Your cancer can be measured on a scan using standard medical guidelines
  • You are 18 years of age or older
  • You are reasonably able to carry out daily activities (your doctor will assess your general fitness level)
  • Your blood cell counts, liver function, kidney function, and heart function are all within acceptable ranges, confirmed by blood tests taken within 28 days before starting treatment
  • Your heart is pumping at least 50% efficiency, confirmed within 28 days before starting treatment
  • If you are a woman who could become pregnant, you must have a negative pregnancy test before starting the study
  • If you could become pregnant or could father a child, you must agree to use reliable contraception during the study and for 3 months after finishing treatment
  • You are willing and able to attend all scheduled visits, follow the treatment plan, complete required tests, and have blood samples taken for research purposes
  • You have read and signed an informed consent form showing you understand what the study involves, including its experimental nature, risks, and alternatives

Who may not be able to join:

  • Your colon or rectal cancer has spread to other parts of the body (stage IV), even if surgery with curative intent is being planned
  • Your tumor's HER2 test results do not meet the specific requirements described above
  • Your tumor has a RAS gene mutation
  • You have rectal cancer that is classified as MSI-H or mismatch repair deficient (a specific genetic characteristic — confirm with trial site)
  • You have significant heart problems, such as uncontrolled high blood pressure, serious heart rhythm issues, a history of heart failure with symptoms, or a heart attack or unstable chest pain within the past 6 months
  • You have taken part in another clinical trial or used an experimental treatment within the past 28 days
  • You have a history of serious allergic reactions to drugs that are similar to the ones used in this trial
  • You currently have an uncontrolled illness, such as an active infection, heart problems, or a mental health or personal situation that would make it difficult to follow the study requirements

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Olumide B. Gbolahan, MBBS, MSc, Emory University Hospital/Winship Cancer Institute

Phone: 404-778-1900

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
7 April 2026
Est. completion
18 December 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Rate of Complete and Major Pathologic Regression (Cohort 1); Radiologic Response (Cohort 2); Tumor Regression Grades (Cohort 2)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov