Phase 1 Colorectal Cancer Trial, Recruiting NCT07416552 Sponsor: Hoffmann-La Roche Condition: Colorectal Cancer
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Phase 1 Colorectal Cancer Trial, Recruiting

NCT07416552
Recruiting Phase 1

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:

  • People who have been diagnosed with bowel cancer (starting in the colon or rectum) that has spread to other parts of the body (Stage IV), confirmed by a tissue test
  • People whose cancer has been tested and found to be a specific type called MSS and/or "proficient mismatch repair" (confirm with trial site if unsure what this means)
  • People whose cancer got worse during treatment, or within 3 months after finishing their last cancer treatment for the spread of the disease
  • People whose cancer can be measured on scans, using a standard set of measurement rules called RECIST v1.1
  • People who are expected by their doctor to live at least 12 weeks or more
  • People who are reasonably active and able to care for themselves, as measured by a standard scale called ECOG Performance Status 0 or 1 (confirm with trial site)
  • People whose heart, blood, and kidney function meet the required levels based on test results

Who may not be able to join:

  • People who are pregnant, breastfeeding, or planning to become pregnant
  • People who have cancer that has spread to the brain or spinal cord and is currently active
  • People who have had a different type of cancer in the past (other than the one being studied in this trial)
  • People who still have unresolved side effects from previous cancer treatments such as radiation, chemotherapy, targeted therapy, or surgery
  • People who have had major surgery or a serious physical injury within 4 weeks before the start of the trial treatment, or who are expected to need major surgery during the trial (routine tissue biopsies are not included in this)
  • People who have a confirmed positive test result for HIV
  • People who test positive for Hepatitis B at the screening stage
  • People who test positive for Hepatitis C at the screening stage
  • People who have received any cancer treatment or experimental treatment within 4 weeks (or a shorter period depending on how the treatment works in the body) before the trial begins
  • People who have previously been treated with a therapy that targets a protein called CEA, or who have received systemic radiation therapy in the past

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 6 July 2026
Phase 1: approximately ~10% 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: Clinical Trials, Hoffmann-La Roche

Phone: 888-662-6728 (U.S. and Canada)

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 1
Registry
ClinicalTrials.gov
Start date
16 June 2026
Est. completion
12 February 2034

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Part 1: Serum Concentration of SPLIT Abs; Part 1: Time Course of Blood, Plasma, and Urine Radioactivity for 203Pb-DOTAM; Part 1 to 2: Absorbed Radiation Dose of 212Pb-DOTAM extrapolated from 203Pb-DOTAM; Part 1 to 3: Percentage of Participants With Adverse Events (AE)

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: 6 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