Phase 3 study for people with Colorectal Cancer

Recruiting Phase 3

Sources: ClinicalTrials.gov Checked: 15 October 2026 Not medical advice

This trial at a glance

Status Recruiting
Phase Phase 3
Sponsor EMD Serono Research & Development Institute, Inc.
Registry number NCT07549412
Started 6 May 2026 Today 16 October 2026 Estimated completion 16 October 2029

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
GenesisCare North Shore (Oncology) St Leonards NSW Recruiting
Icon Cancer Centre Chermside Chermside QLD Recruiting
Mater Misericordiae Ltd - PARENT South Brisbane QLD Recruiting
Flinders Medical Centre Bedford Park SA Recruiting

voxsanity.com.au · trial sites from public registries · registry record synced 15 October 2026 · not medical advice

Who can join

Age 18 Years and over
Sex Anyone, regardless of sex
Healthy volunteers Not accepted
Enrolment target 1020

The official eligibility criteria

Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.

Inclusion Criteria:

* Participants with documented histopathological diagnosis of metastatic colorectal cancer, who were intolerant to, or whose disease was refractory to, or progressed after standard systemic therapies and no more than 2 previous systemic treatment regimens in the metastatic setting.

* Participants must have received and progressed on no more than 2 previous systemic treatment regimens in the metastatic setting

* Eastern Cooperative Oncology Group (ECOG) performance status less than equal to 1

* Participants must be able to swallow oral tablets, and to comply with the study requirements for all scheduled evaluations

* Other protocol defined inclusion criteria may apply

Exclusion Criteria:

* If Adverse Events related to previous therapies have not recovered to less than Grade 1 by National Cancer Institute - Common Terminology Criteria for Adverse Events version 6.0

* Participant has a history of additional malignancy within 3 years before randomization

* Participants with known brain metastases

* Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months prior to randomization

* Participants with ileus of more than Grade 1, or chronic inflammatory bowel disease (example ulcerative colitis, Crohn's disease) and/or bowel obstruction, or participants with chronic gastrointestinal disorders that, in the Investigator's opinion, might significantly interfere with proper absorption of the study treatments

* Other protocol defined exclusion criteria may apply

Dates on the record

Started 6 May 2026
Estimated completion 16 October 2029
Registry last updated 8 October 2026
Checked by Voxsanity 15 October 2026

Results, publications and the official record

Sources and dates

  • ClinicalTrials.gov – the record this page reformats
  • ClinicalTrials.gov processing date: 8 October 2026.
  • This page last checked by Voxsanity: 15 October 2026.

Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.

Not medical advice.

Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.

Letter for your doctor

A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.