Phase Ib Study With the Combination of LB-100 (PP2A Inhibitor) and Atezolizumab (PD-L1 Inhibitor) in Metastatic Colorectal Cancer Patients - The CoLBAt Trial
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.
• 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 documented at that site since radiation;
• 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.