Recruiting nowPhase 2
What this trial is trying to do
The researchers are testing whether oral SR-8541A combined with two immune-checkpoint drugs, botensilimab and balstilimab, can make treatment more effective in metastatic microsatellite-stable colorectal cancer (MSS-CRC), including cancer that has spread to the liver. The study also tests different doses to find one suitable for further development.
The idea is that the combination could control cancer that is being studied in this specific MSS-CRC group, where the trial measures safety, tolerability and signs of treatment activity. There is no comparison group, so the study cannot show whether it helps people live longer or delays growth more than standard treatment.
Worth knowing: This is an open-label, non-randomised phase 2 trial with no control group, and its main focus includes finding a safe dose rather than proving a survival 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 | NCT06589440 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 2 |
| Design | not randomised, open label |
| Taking part | 70 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | Stingray Therapeutics |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug SR-8541A
What it is measuring
To evaluate the safety, tolerability, efficacy, and define the optimal dose for expansion of SR-8541A in combination with botensilimab and balstilimab
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
This is an open-label, dose escalation and expansion, multi-center phase 2 study evaluating the safety and efficacy of SR-8541A administered orally in combination with intravenous botensilimab and balstilimab in subjects with MSS-CRC with and without active liver metastases.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- 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
1. Written informed consent from subject
2. Age ≥ 18 years old on the date of consent
3. Histologically confirmed diagnosis of unresectable and metastatic adenocarcinoma of the colon or rectum
4. Non-microsatellite instability high or non-deficient mismatch repair (non-MSI-H/non-dMMR) tumor status per a standard local testing method
5. Must have received at least 1 prior chemotherapy regimen for metastatic or recurrent CRC
6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
7. Measurable disease per RECIST v1.1 (Eisenhauer et al., 2009)
8. Able to provide archival or fresh tumor tissue during screening (required) and post-treatment (optional)
9. Adequate renal function defined as creatinine clearance ≥ 60mL/min
10. Adequate liver function
11. Adequate hematologic function
12. No growth factor support, transfusions, or albumin administration within 14 days of first dose of study treatment
13. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
14.
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 6 sites. 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 NCT06589440, registered by Stingray Therapeutics 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.