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New treatment option for Metastatic Microsatellite-stable Colorectal Cancer
Official title LB-100 (PP2A Inhibitor) and Atezolizumab (PD-L1 Inhibitor) in Metastatic Colorectal Cancer Patients
ClinicalTrials.gov ID: NCT06012734
What this study is testing
What is LB-100?
LB-100 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for metastatic microsatellite-stable colorectal cancer.
Also referred to as PP2A inhibitor LB-100.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Signed Informed Consent Form (ICF);
- Age ≥ 18 years at time of signing ICF;
- Ability to comply with the study protocol;
- Histological or cytological confirmed colorectal cancer;
- Immunohistochemically confirmation of microsatellite stable (MSS) phenotype;
You likely can't join if
- Unable to follow study procedures;
- Patients using prohibited medication;
- Any unresolved grade ≥ 2 toxicities related to prior treatments (excluding alopecia) according to CTCAE version 5.0;
- Symptomatic or actively progressing central nervous system (CNS) metastases. Asymptomatic patients with treated or untreated CNS lesions are...
- Measurable disease, per RECIST v1.1, must be present outside the CNS;
- The patient has no history of intracranial haemorrhage or spinal cord haemorrhage;
See the full eligibility criteria
Who can join
- Signed Informed Consent Form (ICF);
- Age ≥ 18 years at time of signing ICF;
- Ability to comply with the study protocol;
- Histological or cytological confirmed colorectal cancer;
- Immunohistochemically confirmation of microsatellite stable (MSS) phenotype;
- Disease progression during treatment with standard of care;
- 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...
- Able and willing to undergo blood sampling and tumour biopsies at baseline, if no adequate archival material is available, and during therapy;
- Availability of representative tumor specimen for exploratory biomarker research;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Life expectancy of at least 3 months;
- 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;
- Negative hepatitis B test at screening;
- Negative hepatitis C virus test at screening;
- Adequate hematologic and end-organ function as defined by:
- Absolute neutrophil (segmented and bands) count ≥1.0×109/L
- Lymphocyte count ≥0.5×109/L
- Platelets≥100×109/L
- Hemoglobin ≥5.6 mmol/L
- AST≤2.5×ULN
- ALT≤2.5×ULN
- AP ≤2.5×ULN
- Bilirubin ≤1.5×ULN
- Estimated glomerular filtration rate ≥50 mL/min by CKD-EPI
- Albumin ≥25 g/L
- INR ≤1.5×ULN
- aPTT ≤1.5×ULN
- Negative pregnancy test (urine or serum) for female patients with childbearing potential.
What rules you out
- Unable to follow study procedures;
- Patients using prohibited medication;
- Any unresolved grade ≥ 2 toxicities related to prior treatments (excluding alopecia) according to CTCAE version 5.0;
- Symptomatic or actively progressing central nervous system (CNS) metastases. Asymptomatic patients with treated or untreated CNS lesions are eligible, provided that all of the following criteria are met:
- Measurable disease, per RECIST v1.1, must be present outside the CNS;
- The patient has no history of intracranial haemorrhage or spinal cord haemorrhage;
- The patient has not undergone stereotactic radiotherapy within 7 days prior to initiation of study treatment, whole-brain radiotherapy within 14 days prior to initiation of study treatment, or neurosurgical resection...
- The patient has no ongoing requirement for corticosteroids as therapy for CNS disease;
- If the patient is receiving anti-convulsant therapy, the dose is considered stable;
- History of leptomeningeal disease;
- Uncontrolled tumor-related pain. Patients requiring pain medication must be on a sta-ble regimen at study entry;
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures. Patients with indwelling catheters are allowed;
- Uncontrolled symptomatic hypercalcemia (ionized calcium \> 1.5 mmol/L, calcium \>12 mg/dL, or corrected calcium greater than ULN);
- Active or history of auto-immune disease or immune deficiency;
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the...
- Active tuberculosis;
- Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment...
- Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study;
- History of malignancy within 2 years prior to initiation of study treatment, with the exception of the cancer under investigation in this study and malignancies with a negligible risk of metastasis or death (e.g...
- Severe infection within 4 weeks prior to initiation of study treatment;
- Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment. Patients receiving prophylactic antibiotics are eligible for the study;
- Prior allogeneic stem cell or solid organ transplantation;
- Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render...
- Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of...
- Current treatment with anti-viral therapy for HBV;
- Treatment with investigational therapy within 28 days prior to initiation of study treat-ment;
- Prior treatment with CD137 agonists or immune checkpoint blockade therapies;
- Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug-elimination half-lives prior to initiation of study treatment;
- Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment;
- History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins;
- Known hypersensitivity to Chinese hamster ovary cell products or to any component of the Atezolizumab formulation;
- Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after the final dose of study treatment.
The study team makes the final eligibility decision.
Where it's taking place
- Amsterdam, North Holland, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amsterdam, North Holland, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.