Recruiting nowPhase 1Randomised
What this trial is trying to do
The researchers are testing whether ulixertinib, a drug that blocks signalling through the ERK pathway inside cancer cells, can be given with cetuximab and/or encorafenib after previous EGFR- or BRAF-directed treatment. The trial is mainly finding doses that can be given safely in these combinations.
The idea is that blocking a downstream signalling route may help overcome resistance to earlier targeted treatment. The measured outcome is treatment-related side effects, not whether patients live longer or go longer before the cancer grows.
Worth knowing: This is a small, early phase 1 study with no comparison group, so it is designed to assess safety and dosing rather than prove benefit.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
| Registry number | NCT05985954 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 1 |
| Design | randomised, open label |
| Taking part | 27 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | M.D. Anderson Cancer Center |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug Cetuximab
- Drug Ulixertinib
- Drug Encorafenib
What it is measuring
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
Phase 1. Tests safety and dose in a small group. Some people do benefit, but that is not what the trial is designed to find out.
How the researchers describe it
To find the recommended dose of ulixertinib that can be given in combination with cetuximab and/or encorafenib to patients with unresectable/metastatic CRC and who have received EGFR or BRAF-directed therapy in the past.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- (K/N)RAS mutated
- BRAF V600E
- Metastatic
- Rectal
- Colon
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
Inclusion Criteria
Patients must meet all of the inclusion criteria to be eligible:
1. Provision of signed Informed Consent prior to any screening procedures being performed.
1. Non-English speaking patients will be eligible for participation with involvement of the MD Anderson Language Assistance department in the informed consent process (per MD Anderson SOP 04_Informed Consent Process).
2. Individuals lacking the ability, based on reasonable medical judgment, to understand and appreciate the nature and consequences of participation in this study will not be eligible for participation.
2. Age ≥ 18 years at the time of informed consent.
3. Histologically (or cytologically) confirmed diagnosis of adenocarcinoma of the colon or rectum, with clinical confirmation of unresectable and/or metastatic disease that is measurable according to RECIST1.1 criteria.
4. Mutation status at the time of colorectal cancer diagnosis performed on tumor tissue or circulating tumor DNA (prior to any systemic chemotherapy):
1. Cohort A: KRAS, NRAS, EGFR ectodomain, BRAF V600E wild-type status
2. BRAF expansion Cohort: BRAF V600E mutation must be present
5. Prior treatment with at least one systemic chemotherapy regimen for mCRC, or recurrence/progression with development of unresectable or metastatic disease within 6 months of adjuvant chemotherapy for resected colorectal cancer.
6.
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 1 site. Listed in: United States.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT05985954, registered by M.D. Anderson Cancer Center on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.