Recruiting nowPhase 2
What this trial is trying to do
The trial is designed to let people who are already benefiting from opnurasib, alone or with another study treatment, continue receiving it. The researchers will continue assessing safety rather than testing a new treatment approach.
The aim is continued access for participants who are benefiting in earlier Novartis-sponsored studies, with the main measure being how many receive opnurasib. There is no comparison group and the study is not designed to show whether the treatment helps people live longer or delays tumour growth.
Worth knowing: This is a non-randomised rollover study for people already receiving and benefiting from opnurasib, so it cannot establish treatment 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 | NCT07468071 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 2 |
| Design | not randomised, open label |
| Taking part | 40 people (planned) |
| Who can join | aged 18 Years to 100 Years |
| Run by | Novartis Pharmaceuticals |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug Opnurasib
- Drug TNO155
- Drug trametinib
- Biological cetuximab
- Biological tislelizumab
What it is measuring
Number of participants receiving opnurasib as single agent or in combination with other study treatments
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 2. Tests whether the treatment works well enough to be worth a larger trial. Usually too small to prove it changes survival.
How the researchers describe it
The purpose of this study is to allow continued access to opnurasib (JDQ443) to participants who are benefitting from treatment with opnurasib as a single agent or in combination with other study treatments in pre-defined Novartis-sponsored opnurasib studies and to continue to assess safety in these participants.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- (K/N)RAS mutated
- G12C
- Metastatic
- Locally advanced
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
Key Inclusion Criteria
- Participant is currently enrolled in a pre-defined Novartis-sponsored study and is receiving opnurasib as single agent or in combination with other study treatment.
- Participant has received at least 6 cycles of opnurasib in a parent study.
- Participant is currently deriving clinical benefit from the study treatment, as determined by the Investigator.
- Participants currently receiving treatment in one of the KontRASt studies, including those who have not experienced disease progression or who are continuing treatment beyond initial disease progression, may be eligible to enroll in the rollover study if, in the Investigator's judgment, they are expected to continue deriving clinical benefit from treatment with opnurasib (alone or in combination).
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 21 sites. Listed in: Belgium, Canada, China, Denmark, France, Italy, Japan, Malaysia, South Korea, Spain.
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?
- This trial recruits across several cancer types rather than being designed around bowel cancer. Is there evidence it does anything in mine?
The source
Registry record NCT07468071, registered by Novartis Pharmaceuticals 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.