xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06012734</url>
    </required_header>
    <id_info>
      <org_study_id>N22CLB</org_study_id>
      <nct_id>NCT06012734</nct_id>
    </id_info>
    <brief_title>LB-100 (PP2A Inhibitor) and Atezolizumab (PD-L1 Inhibitor) in Metastatic Colorectal Cancer Patients</brief_title>
    <acronym>CoLBAt</acronym>
    <official_title>Phase Ib Study With the Combination of LB-100 (PP2A Inhibitor) and Atezolizumab (PD-L1 Inhibitor) in Metastatic Colorectal Cancer Patients - The CoLBAt Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The Netherlands Cancer Institute</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>The Netherlands Cancer Institute</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This Phase Ib trial studies the side effects and best dose of LB-100 when given with&#xD;
        atezolizumab for the treatment of patients with metastatic microsatellite stable colorectal&#xD;
        cancer. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's&#xD;
        immune system attack the cancer, and may interfere with the ability of the tumor to grow and&#xD;
        spread. LB-100 has been shown to make anticancer drugs work better at killing cancer. LB-100&#xD;
        blocks a protein on the surface of cells called PP2A. Blocking this protein increases the&#xD;
        stress signals for the tumor cells that express PP2A. Giving atezolizumab in combination with&#xD;
        LB-100 may work better to treat metastatic colorectal cancer patients as the cancer cells&#xD;
        that experience increased stress signals are more susceptible for the immunotherapy.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The goal of this Phase Ib monocenter, open-label, non-randomized clinical trial is to&#xD;
        evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of the&#xD;
        combination of LB-100 and atezolizumab in patients with metastatic microsatellite stable&#xD;
        colorectal cancer.&#xD;
  &#xD;
        This study will consist of a dose escalation phase and a dose expansion phase. The dose&#xD;
        escalation phase is designed to find the recommended phase II dose of LB-100 in combination&#xD;
        with atezolizumab standard dosage of 1200 mg. The dose expansion phase further explores the&#xD;
        clinical activity, safety, tolerability and pharmacokinetics/dynamics of LB-100 combined with&#xD;
        atezolizumab.&#xD;
  &#xD;
        LB-100 will be administered intravenously on day 1 and day 3 of every 21-day cycle.&#xD;
  &#xD;
        Atezolizumab 1200 mg will be administered intravenously on day 1 of every 21-day cycle, which&#xD;
        is the labelled dose as monotherapy.&#xD;
  &#xD;
        Clinical assessments will be performed routinely to monitor safety. Anti-tumor activity will&#xD;
        be measured by CT scan according to RECIST version 1.1 criteria. Tumor biopsies will be&#xD;
        obtained for exploratory objectives.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 2023</start_date>
    <completion_date type="Anticipated">July 2026</completion_date>
    <primary_completion_date type="Anticipated">July 2026</primary_completion_date>
    <phase>Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The RP2D of LB-100 when given in combination with standard doses of atezolizumab</measure>
      <time_frame>up to 2 years</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Disease control rate</measure>
      <time_frame>6 months</time_frame>
      <description>Measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Objective response rate</measure>
      <time_frame>6 months</time_frame>
      <description>Measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of overall response</measure>
      <time_frame>up to 2 years</time_frame>
      <description>Measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progression free survival</measure>
      <time_frame>up to 2 years</time_frame>
      <description>Measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall survival</measure>
      <time_frame>Assessed up to 2 years</time_frame>
      <description>The time from the first dose of study treatment to the time of death from any cause. Patients who are still alive at the time of analysis will be censored at the time of their last study assessment (for active patients) or at the last date know alive (for patients in follow-up).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Observed plasma concentrations of LB-100, its active metabolite endothall and atezolizumab</measure>
      <time_frame>Prior to initial dose, on day 1, day 2, day 3, day 8, day 15 and prior to second cycle. Each cycle is 21 days</time_frame>
      <description>Blood samples are obtained and plasma concentrations of LB-100, endothall and atezolizumab are measured</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Area under the plasma-time concentration curve of LB-100, its active metabolite endothall and atezolizumab</measure>
      <time_frame>Prior to initial dose, on day 1, day 2, day 3, day 8, day 15 and prior to second cycle. Each cycle is 21 days</time_frame>
      <description>Blood samples are obtained and plasma concentrations of LB-100, endothall and atezolizumab are measured</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Elimination half-life of LB-100, its active metabolite endothall and atezolizumab</measure>
      <time_frame>Prior to initial dose, on day 1, day 2, day 3, day 8, day 15 and prior to second cycle. Each cycle is 21 days</time_frame>
      <description>Blood samples are obtained and plasma concentrations of LB-100, endothall and atezolizumab are measured</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total body clearance of LB-100, its active metabolite endothall and atezolizumab</measure>
      <time_frame>Prior to initial dose, on day 1, day 2, day 3, day 8, day 15 and prior to second cycle. Each cycle is 21 days</time_frame>
      <description>Blood samples are obtained and plasma concentrations of LB-100, endothall and atezolizumab are measured</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The incidence and severity of adverse events</measure>
      <time_frame>Up to 2 years</time_frame>
      <description>As assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The incidence of dose-limiting toxicity</measure>
      <time_frame>21 days</time_frame>
      <description>As assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Serine/threonine hyperphosphorylation in peripheral white blood cells</measure>
      <time_frame>Blood sample cycle 1 day 1. Each cycle is 21 days.</time_frame>
      <description>Western Blots to evaluate serine/threonine hyperphosphorylation in peripheral white blood cells</description>
    </other_outcome>
    <other_outcome>
      <measure>Mismatch repair deficiency status</measure>
      <time_frame>Before start of treatment and one on treatment biopsy at Cycle 3 day 3. Each cycle is 21 days</time_frame>
      <description>Immunohistochemistry for mismatch repair proteins</description>
    </other_outcome>
    <other_outcome>
      <measure>Concentration of LB-100 and endothall in tumor tissue</measure>
      <time_frame>On treatment biopsy at Cycle 3 day 3. Each cycle is 21 days</time_frame>
      <description>To evaluate pharmacodynamic biomarkers of LB-100</description>
    </other_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">37</enrollment>
    <condition>Metastatic Microsatellite-stable Colorectal Cancer</condition>
    <arm_group>
      <arm_group_label>LB-100 plus atezolizumab</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>LB-100 IV over 15 minutes on day 1 and day 3 Atezolizumab IV over 30-60 minutes on day 1 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>LB-100</intervention_name>
      <description>IV on day 1 and day 3</description>
      <arm_group_label>LB-100 plus atezolizumab</arm_group_label>
      <other_name>PP2A inhibitor LB-100</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Atezolizumab</intervention_name>
      <description>IV on day 1</description>
      <arm_group_label>LB-100 plus atezolizumab</arm_group_label>
      <other_name>Tecentriq</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Signed Informed Consent Form (ICF);&#xD;
  &#xD;
            2. Age ≥ 18 years at time of signing ICF;&#xD;
  &#xD;
            3. Ability to comply with the study protocol;&#xD;
  &#xD;
            4. Histological or cytological confirmed colorectal cancer;&#xD;
  &#xD;
            5. Immunohistochemically confirmation of microsatellite stable (MSS) phenotype;&#xD;
  &#xD;
            6. Disease progression during treatment with standard of care;&#xD;
  &#xD;
            7. Measurable disease per Response Evaluation Criteria in Solid Tumours version 1.1&#xD;
               (RECIST v1.1). Previously irradiated lesions can be considered as measurable disease&#xD;
               only if progressive disease has been unequivocally documented at that site since&#xD;
               radiation;&#xD;
  &#xD;
            8. Able and willing to undergo blood sampling and tumour biopsies at baseline, if no&#xD;
               adequate archival material is available, and during therapy;&#xD;
  &#xD;
            9. Availability of representative tumor specimen for exploratory biomarker research;&#xD;
  &#xD;
           10. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;&#xD;
  &#xD;
           11. Life expectancy of at least 3 months;&#xD;
  &#xD;
           12. Negative HIV test at screening. Patients with a positive HIV test at screening are&#xD;
               eligible provided they are stable on anti-retroviral therapy, have a CD4 count ≥&#xD;
               200/µL, and have an undetectable viral load;&#xD;
  &#xD;
           13. Negative hepatitis B test at screening;&#xD;
  &#xD;
           14. Negative hepatitis C virus test at screening;&#xD;
  &#xD;
           15. Adequate hematologic and end-organ function as defined by:&#xD;
  &#xD;
                 -  Absolute neutrophil (segmented and bands) count ≥1.0×109/L&#xD;
  &#xD;
                 -  Lymphocyte count ≥0.5×109/L&#xD;
  &#xD;
                 -  Platelets≥100×109/L&#xD;
  &#xD;
                 -  Hemoglobin ≥5.6 mmol/L&#xD;
  &#xD;
                 -  AST≤2.5×ULN&#xD;
  &#xD;
                 -  ALT≤2.5×ULN&#xD;
  &#xD;
                 -  AP ≤2.5×ULN&#xD;
  &#xD;
                 -  Bilirubin ≤1.5×ULN&#xD;
  &#xD;
                 -  Estimated glomerular filtration rate ≥50 mL/min by CKD-EPI&#xD;
  &#xD;
                 -  Albumin ≥25 g/L&#xD;
  &#xD;
                 -  INR ≤1.5×ULN&#xD;
  &#xD;
                 -  aPTT ≤1.5×ULN&#xD;
  &#xD;
           16. Negative pregnancy test (urine or serum) for female patients with childbearing&#xD;
               potential.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Unable to follow study procedures;&#xD;
  &#xD;
            2. Patients using prohibited medication;&#xD;
  &#xD;
            3. Any unresolved grade ≥ 2 toxicities related to prior treatments (excluding alopecia)&#xD;
               according to CTCAE version 5.0;&#xD;
  &#xD;
            4. Symptomatic or actively progressing central nervous system (CNS) metastases.&#xD;
               Asymptomatic patients with treated or untreated CNS lesions are eligible, provided&#xD;
               that all of the following criteria are met:&#xD;
  &#xD;
                 -  Measurable disease, per RECIST v1.1, must be present outside the CNS;&#xD;
  &#xD;
                 -  The patient has no history of intracranial haemorrhage or spinal cord&#xD;
                    haemorrhage;&#xD;
  &#xD;
                 -  The patient has not undergone stereotactic radiotherapy within 7 days prior to&#xD;
                    initiation of study treatment, whole-brain radiotherapy within 14 days prior to&#xD;
                    initiation of study treatment, or neurosurgical resection within 28 days prior to&#xD;
                    initiation of study treatment;&#xD;
  &#xD;
                 -  The patient has no ongoing requirement for corticosteroids as therapy for CNS&#xD;
                    disease;&#xD;
  &#xD;
                 -  If the patient is receiving anti-convulsant therapy, the dose is considered&#xD;
                    stable;&#xD;
  &#xD;
            5. History of leptomeningeal disease;&#xD;
  &#xD;
            6. Uncontrolled tumor-related pain. Patients requiring pain medication must be on a&#xD;
               sta-ble regimen at study entry;&#xD;
  &#xD;
            7. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent&#xD;
               drainage procedures. Patients with indwelling catheters are allowed;&#xD;
  &#xD;
            8. Uncontrolled symptomatic hypercalcemia (ionized calcium &gt; 1.5 mmol/L, calcium &gt;12&#xD;
               mg/dL, or corrected calcium greater than ULN);&#xD;
  &#xD;
            9. Active or history of auto-immune disease or immune deficiency;&#xD;
  &#xD;
           10. History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced&#xD;
               pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening&#xD;
               chest CT scan. History of radiation pneumonitis in the radiation field is permitted;&#xD;
  &#xD;
           11. Active tuberculosis;&#xD;
  &#xD;
           12. Significant cardiovascular disease (such as New York Heart Association Class II or&#xD;
               greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3&#xD;
               months prior to initiation of study treatment, unstable arrhythmia, or unstable&#xD;
               angina;&#xD;
  &#xD;
           13. Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation&#xD;
               of study treatment, or anticipation of need for a major surgical procedure during the&#xD;
               study;&#xD;
  &#xD;
           14. History of malignancy within 2 years prior to initiation of study treatment, with the&#xD;
               exception of the cancer under investigation in this study and malignancies with a&#xD;
               negligible risk of metastasis or death (e.g., 5-year OS rate &gt;90%);&#xD;
  &#xD;
           15. Severe infection within 4 weeks prior to initiation of study treatment;&#xD;
  &#xD;
           16. Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation&#xD;
               of study treatment. Patients receiving prophylactic antibiotics are eligible for the&#xD;
               study;&#xD;
  &#xD;
           17. Prior allogeneic stem cell or solid organ transplantation;&#xD;
  &#xD;
           18. Any other disease, metabolic dysfunction, physical examination finding, or clinical&#xD;
               laboratory finding that contraindicates the use of an investigational drug, may affect&#xD;
               the interpretation of the results, or may render the patient at high risk from&#xD;
               treatment complications;&#xD;
  &#xD;
           19. Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study&#xD;
               treatment, or anticipation of need for such a vaccine during atezolizumab treatment or&#xD;
               within 5 months after the final dose of atezolizumab;&#xD;
  &#xD;
           20. Current treatment with anti-viral therapy for HBV;&#xD;
  &#xD;
           21. Treatment with investigational therapy within 28 days prior to initiation of study&#xD;
               treat-ment;&#xD;
  &#xD;
           22. Prior treatment with CD137 agonists or immune checkpoint blockade therapies;&#xD;
  &#xD;
           23. Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug-elimination&#xD;
               half-lives prior to initiation of study treatment;&#xD;
  &#xD;
           24. Treatment with systemic immunosuppressive medication within 2 weeks prior to&#xD;
               initiation of study treatment, or anticipation of need for systemic immunosuppressive&#xD;
               medication during study treatment;&#xD;
  &#xD;
           25. History of severe allergic anaphylactic reactions to chimeric or humanized antibodies&#xD;
               or fusion proteins;&#xD;
  &#xD;
           26. Known hypersensitivity to Chinese hamster ovary cell products or to any component of&#xD;
               the Atezolizumab formulation;&#xD;
  &#xD;
           27. Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment&#xD;
               or within 5 months after the final dose of study treatment.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Neeltje Steeghs, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>The Netherlands Cancer Institute - Antoni van Leeuwenhoek</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Merel Lucassen, MD</last_name>
      <phone>+31205129111</phone>
      <email>me.lucassen@nki.nl</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Gastrointestinal Neoplasms</keyword>
    <keyword>Colorectal cancer</keyword>
    <keyword>Metastatic colorectal cancer</keyword>
    <keyword>Microsatellite stable</keyword>
    <keyword>Immune checkpoint inhibitors</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Colorectal Neoplasms</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Atezolizumab</mesh_term>
      <mesh_term>LB100</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06012734
  org study id: N22CLB
  nct id: NCT06012734
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  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.
  The goal of this Phase Ib monocenter, open-label, non-randomized clinical trial is to
        evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of the
        combination of LB-100 and atezolizumab in patients with metastatic microsatellite stable
        colorectal cancer.
  
        This study will consist of a dose escalation phase and a dose expansion phase. The dose
        escalation phase is designed to find the recommended phase II dose of LB-100 in combination
        with atezolizumab standard dosage of 1200 mg. The dose expansion phase further explores the
        clinical activity, safety, tolerability and pharmacokinetics/dynamics of LB-100 combined with
        atezolizumab.
  
        LB-100 will be administered intravenously on day 1 and day 3 of every 21-day cycle.
  
        Atezolizumab 1200 mg will be administered intravenously on day 1 of every 21-day cycle, which
        is the labelled dose as monotherapy.
  
        Clinical assessments will be performed routinely to monitor safety. Anti-tumor activity will
        be measured by CT scan according to RECIST version 1.1 criteria. Tumor biopsies will be
        obtained for exploratory objectives.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: The RP2D of LB-100 when given in combination with standard doses of atezolizumab
  time frame: up to 2 years
  measure: Disease control rate
  time frame: 6 months
  description: Measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
  measure: Objective response rate
  time frame: 6 months
  description: Measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
  measure: Duration of overall response
  time frame: up to 2 years
  description: Measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
  measure: Progression free survival
  time frame: up to 2 years
  description: Measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
  measure: Overall survival
  time frame: Assessed up to 2 years
  description: The time from the first dose of study treatment to the time of death from any cause. Patients who are still alive at the time of analysis will be censored at the time of their last study assessment (for active patients) or at the last date know alive (for patients in follow-up).
  measure: Observed plasma concentrations of LB-100, its active metabolite endothall and atezolizumab
  time frame: Prior to initial dose, on day 1, day 2, day 3, day 8, day 15 and prior to second cycle. Each cycle is 21 days
  description: Blood samples are obtained and plasma concentrations of LB-100, endothall and atezolizumab are measured
  measure: Area under the plasma-time concentration curve of LB-100, its active metabolite endothall and atezolizumab
  time frame: Prior to initial dose, on day 1, day 2, day 3, day 8, day 15 and prior to second cycle. Each cycle is 21 days
  description: Blood samples are obtained and plasma concentrations of LB-100, endothall and atezolizumab are measured
  measure: Elimination half-life of LB-100, its active metabolite endothall and atezolizumab
  time frame: Prior to initial dose, on day 1, day 2, day 3, day 8, day 15 and prior to second cycle. Each cycle is 21 days
  description: Blood samples are obtained and plasma concentrations of LB-100, endothall and atezolizumab are measured
  measure: Total body clearance of LB-100, its active metabolite endothall and atezolizumab
  time frame: Prior to initial dose, on day 1, day 2, day 3, day 8, day 15 and prior to second cycle. Each cycle is 21 days
  description: Blood samples are obtained and plasma concentrations of LB-100, endothall and atezolizumab are measured
  measure: The incidence and severity of adverse events
  time frame: Up to 2 years
  description: As assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
  measure: The incidence of dose-limiting toxicity
  time frame: 21 days
  description: As assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
  measure: Serine/threonine hyperphosphorylation in peripheral white blood cells
  time frame: Blood sample cycle 1 day 1. Each cycle is 21 days.
  description: Western Blots to evaluate serine/threonine hyperphosphorylation in peripheral white blood cells
  measure: Mismatch repair deficiency status
  time frame: Before start of treatment and one on treatment biopsy at Cycle 3 day 3. Each cycle is 21 days
  description: Immunohistochemistry for mismatch repair proteins
  measure: Concentration of LB-100 and endothall in tumor tissue
  time frame: On treatment biopsy at Cycle 3 day 3. Each cycle is 21 days
  description: To evaluate pharmacodynamic biomarkers of LB-100
  arm group label: LB-100 plus atezolizumab
  arm group type: Experimental
  description: LB-100 IV over 15 minutes on day 1 and day 3 Atezolizumab IV over 30-60 minutes on day 1 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity
  intervention type: Drug
  intervention name: LB-100
  description: IV on day 1 and day 3
  arm group label: LB-100 plus atezolizumab
  other name: PP2A inhibitor LB-100
  intervention type: Drug
  intervention name: Atezolizumab
  description: IV on day 1
  arm group label: LB-100 plus atezolizumab
  other name: Tecentriq
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Neeltje Steeghs, MD, PhD
  role: Principal Investigator
  affiliation: The Netherlands Cancer Institute - Antoni van Leeuwenhoek
  last name: Merel Lucassen, MD
  phone: +31205129111
  email: me.lucassen@nki.nl
  responsible party type: Sponsor
  mesh term: Colorectal Neoplasms
  mesh term: Atezolizumab
  mesh term: LB100
  sharing ipd: No