Phase 2 Colorectal Cancer Trial, Recruiting NCT07463599 Sponsor: HonorHealth Research Institute Condition: Colorectal Cancer
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Phase 2 Colorectal Cancer Trial, Recruiting

NCT07463599
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 are 18 years of age or older
  • You have been diagnosed with a specific type of colorectal cancer (adenocarcinoma) that has spread to other parts of the body, confirmed by a tissue or cell sample
  • Your cancer has been tested for certain genetic markers (RAS, BRAF, and MSI/dMMR status) and results are available
  • Your cancer has gotten worse or you could not tolerate at least 2 previous treatments for advanced cancer, which must have included certain standard chemotherapy drugs and a specific type of targeted therapy — and additional treatments depending on your cancer's genetic profile
  • You have at least one area of cancer that can be measured on a scan, as defined by standard medical guidelines
  • You are willing and able to have tumor biopsies (tissue samples) taken during the trial (low-risk biopsies are required; moderate-risk ones are optional; high-risk ones will not be done)
  • You are generally well enough to carry out light activity and care for yourself (this is measured using a standard scale called ECOG, score 0 or 1)
  • Your blood counts, liver function, kidney function, and other blood test results meet specific minimum levels (confirm with trial site)
  • Enough time has passed since your last cancer treatment, radiation, surgery, or other local procedures (specific waiting periods apply depending on the treatment type — confirm with trial site)
  • Any side effects from previous cancer treatment have mostly resolved to mild or no symptoms (some exceptions apply, such as hair loss or mild nerve tingling in the hands/feet)
  • If you previously had Hepatitis C, your treatment is completed, it ended at least one month ago, and the virus is no longer detectable in your blood
  • If you have Hepatitis B, it is being treated and well controlled, with virus levels below a certain threshold in your blood
  • Your blood pressure is adequately controlled (at or below 150/90 mmHg), with or without blood pressure medication, and your medication has not changed in the week before starting the trial

Who may not be able to join:

  • You are currently receiving other cancer treatments or experimental therapies
  • You are taking certain medications that strongly affect how the body processes drugs (called CYP3A4/5 inhibitors or inducers) and cannot stop taking them before the trial starts
  • You have a known inherited condition called Gilbert's syndrome or another genetic condition affecting a specific liver enzyme (UGT1A1) (confirm with trial site)
  • You have had a serious allergic reaction to drugs similar to the ones used in this trial, or to certain yellow food dyes (FD&C Yellow No. 5 or No. 6)
  • You have or have had another active cancer, with some exceptions (such as certain skin cancers treated successfully, cancers fully treated more than 3 years ago, or slow-growing cancers that have never needed treatment)
  • You do not have suitable vein access for blood draws or receiving the trial drug, or have a condition that would make drug delivery or sample collection difficult
  • You are unable to swallow capsules or tablets
  • Your cancer has spread to the brain or the lining around the brain or spinal cord
  • You have an active or ongoing infection (other than controlled Hepatitis B)
  • You have large swollen veins (varices) at risk of serious bleeding that are not being managed with standard treatments
  • You have had a blood clot, stroke, or similar serious blood vessel event within the past 6 months
  • You have significant heart problems, including poorly controlled heart failure, unstable chest pain, irregular heartbeat, certain abnormal heart rhythm measurements on an ECG, a history of a specific heart rhythm disorder, or a heart attack within the past 6 months
  • You are HIV-positive and on combination HIV treatment
  • You are pregnant or breastfeeding
  • You are a woman who could become pregnant, or a man whose partner could become pregnant, and you are not willing to use effective contraception during the trial and for at least 6 months after finishing treatment
  • You have any other significant health condition that the trial doctor believes would make participation unsafe or unsuitable

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 5 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.

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Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
HonorHealth Research Institute
Registry
ClinicalTrials.gov
Start date
17 February 2026
Est. completion
1 January 2029

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]; Maximum Tolerated Dose (MTD)/Administered Dose

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: 5 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