Phase 1 Colorectal Cancer Trial, Recruiting NCT04929223 Sponsor: Hoffmann-La Roche Condition: Colorectal Cancer
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Phase 1 Colorectal Cancer Trial, Recruiting

NCT04929223
Recruiting Phase 1 🇦🇺 Australian site

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 are 18 years of age or older at the time of signing the consent form
  • People who have signed the specific consent form for their group (cohort) in the trial
  • People whose tumour has been tested for certain genetic markers/mutations using an approved, certified laboratory test, with full test results available — this includes blood-based testing done before or during the screening period (confirm with trial site for specific biomarker requirements)
  • People who are reasonably active and able to carry out light daily activities, as measured by a standard performance scale (ECOG score of 0 or 1)
  • People who are expected to live at least 3 months or more, as judged by the treating doctor
  • People who have been diagnosed with bowel cancer (colon or rectal cancer) confirmed by laboratory tissue analysis, that has spread to other parts of the body (metastatic disease)
  • People who have already received prior treatment for their metastatic disease
  • People who have at least one measurable tumour that can be tracked using standard imaging criteria
  • People who have adequate blood counts and organ function within 14 days before starting the study treatment
  • People who are able to follow the study requirements, in the doctor's judgement
  • Women who could become pregnant must agree to either avoid heterosexual intercourse or use contraception during the study
  • Men must agree to either avoid intercourse or use contraception, and must agree not to donate sperm during the study
  • People who are willing to provide a baseline tumour tissue sample for research purposes

Who may not be able to join:

  • People who are currently enrolled and actively participating in another clinical trial that involves a treatment (those in the follow-up phase of a previous trial may still be considered)
  • People who have received any systemic cancer treatment within 2 weeks, or within 5 half-lives of the drug (whichever is shorter), before starting the study treatment
  • People who have received an experimental (investigational) treatment within 28 days before starting the study treatment
  • People who are pregnant, breastfeeding, or planning to become pregnant during the study
  • People with a serious medical condition or abnormal laboratory results that, in the doctor's opinion, would make participation unsafe or make it difficult to interpret the study results
  • People who have had a severe infection in the 4 weeks before starting the study treatment, or who have an active infection that the doctor considers a safety risk
  • People who have not fully recovered from a previous surgery in a way that could affect the safety or results of the study
  • People with uncontrolled build-up of fluid around the lungs, heart, or abdomen that requires drainage more than once a month
  • People with cancer-related pain that is not adequately controlled
  • People with uncontrolled or symptomatic high calcium levels in the blood
  • People with clinically significant active liver disease
  • People with HIV, unless they have been stable on HIV treatment for at least 4 weeks, have adequate immune cell counts, have an undetectable viral load, and have not had a serious HIV-related infection in the past 12 months
  • People with brain or central nervous system (CNS) metastases that are causing symptoms, have not been treated, or are actively getting worse
  • People with a history of cancer spreading to the membranes surrounding the brain or spinal cord
  • People who have had a different cancer (other than bowel cancer) within the past 2 years, unless that cancer carries a very low risk of spreading or causing death
  • People with any other condition, unresolved side effects from previous treatment, or laboratory finding that would make use of the study drug unsafe or affect the results
  • People who need to take a medication that is known to interact with or interfere with the study treatments

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 27 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)

Australian sites

Peter Maccallum Cancer Centre, Melbourne, Victoria

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
22 October 2021
Est. completion
31 August 2030

Where this trial is recruiting

🇦🇺 Australia 🇨🇦 Canada 🇩🇰 Denmark 🇩🇪 Germany 🇮🇹 Italy 🇵🇱 Poland 🇰🇷 South Korea 🇪🇸 Spain 🇹🇼 Taiwan 🇬🇧 United Kingdom 🇺🇸 United States

1 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Objective Response Rate

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: 27 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