Recruiting nowPhase 1
What this trial is trying to do
The researchers think blocking PP2A with LB-100 increases stress signals inside tumour cells, making them more vulnerable to atezolizumab, which blocks the PD-L1 immune checkpoint. The trial is testing the combination and the safest dose of LB-100 to give with standard-dose atezolizumab.
The idea is that adding LB-100 could make immunotherapy work better in microsatellite-stable metastatic colorectal cancer, which generally responds less well to checkpoint treatment alone. This early trial is measuring the recommended phase 2 dose and side effects, not whether patients live longer or go longer before the cancer grows.
Worth knowing: This is a small, non-randomised Phase 1b trial, so it has no comparison group and is primarily testing safety and dose rather than 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 | NCT06012734 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 1 |
| Design | open label |
| Taking part | 37 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | The Netherlands Cancer Institute |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug LB-100
- Drug Atezolizumab
What it is measuring
The RP2D of LB-100 when given in combination with standard doses of atezolizumab
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
This Phase Ib trial studies the side effects and best dose of LB-100 when given with atezolizumab for the treatment of patients with metastatic microsatellite stable colorectal cancer. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of the tumor to grow and spread. LB-100 has been shown to make anticancer drugs work better at killing cancer. LB-100 blocks a protein on the surface of cells called PP2A. Blocking this protein increases the stress signals for the tumor cells that express PP2A. Giving atezolizumab in combination with LB-100 may work better to treat metastatic colorectal cancer patients as the cancer cells that experience increased stress signals are more susceptible for the immunotherapy.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Metastatic
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. Signed Informed Consent Form (ICF);
2. Age ≥ 18 years at time of signing ICF;
3. Ability to comply with the study protocol;
4. Histological or cytological confirmed colorectal cancer;
5. Immunohistochemically confirmation of microsatellite stable (MSS) phenotype;
6. Disease progression during treatment with standard of care;
7. Measurable disease per Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST v1.1). Previously irradiated lesions can be considered as measurable disease only if progressive disease has been unequivocally documented at that site since radiation;
8. Able and willing to undergo blood sampling and tumour biopsies at baseline, if no adequate archival material is available, and during therapy;
9. Availability of representative tumor specimen for exploratory biomarker research;
10. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
11. Life expectancy of at least 3 months;
12. Negative HIV test at screening. Patients with a positive HIV test at screening are eligible provided they are stable on anti-retroviral therapy, have a CD4 count ≥ 200/µL, and have an undetectable viral load;
13. Negative hepatitis B test at screening;
14. Negative hepatitis C virus test at screening;
15.
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: Netherlands.
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 NCT06012734, registered by The Netherlands Cancer Institute 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.