Actively Recruiting
LB-100 (PP2A Inhibitor) and Atezolizumab (PD-L1 Inhibitor) in Metastatic Colorectal Cancer Patients
Led by The Netherlands Cancer Institute · Updated on 2024-08-30
37
Participants Needed
1
Research Sites
106 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
LB-100 (PP2A Inhibitor) and Atezolizumab (PD-L1 Inhibitor) in Metastatic Colorectal Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- Age 18 years or older at the time of consent
- Ability to comply with the study protocol
- Histological or cytological confirmed colorectal cancer
- Confirmation of microsatellite stable (MSS) phenotype by immunohistochemistry
- Disease progression during standard of care treatment
- Measurable disease per RECIST version 1.1 criteria
- Willing and able to undergo blood sampling and tumor biopsies if needed
- Availability of representative tumor specimen for biomarker research
- ECOG performance status of 0 or 1
- Life expectancy of at least 3 months
- Negative HIV test or stable HIV with CD4 count ≥ 200/µL and undetectable viral load
- Negative hepatitis B test
- Negative hepatitis C virus test
- Adequate hematologic and organ function as defined by laboratory criteria
- Negative pregnancy test for females with childbearing potential
You will not qualify if you...
- Unable to follow study procedures
- Use of prohibited medications
- Any unresolved grade 2 or higher toxicities from prior treatments (excluding hair loss)
- Symptomatic or actively progressing central nervous system metastases
- History of leptomeningeal disease
- Uncontrolled tumor-related pain not on stable pain medication
- Uncontrolled pleural, pericardial effusion, or ascites requiring frequent drainage
- Uncontrolled symptomatic high calcium levels
- Active or history of autoimmune disease or immune deficiency
- History or evidence of active pneumonitis or certain lung diseases
- Active tuberculosis
- Significant cardiovascular disease within 3 months prior to treatment
- Major surgery within 4 weeks prior to treatment
- History of other malignancies within 2 years except certain exceptions
- Severe infection within 4 weeks prior to treatment
- Therapeutic oral or IV antibiotics within 2 weeks prior to treatment (prophylactic allowed)
- Prior allogeneic stem cell or solid organ transplantation
- Any condition increasing risk from investigational drug or affecting results
- Live attenuated vaccine within 4 weeks prior to treatment or planned during treatment
- Current antiviral therapy for hepatitis B
- Investigational therapy within 28 days prior to treatment
- Prior treatment with CD137 agonists or immune checkpoint blockers
- Systemic immunostimulatory agents within 4 weeks or 5 half-lives before treatment
- Systemic immunosuppressive medication within 2 weeks prior to treatment or planned
- History of severe allergic reactions to certain antibodies or fusion proteins
- Known hypersensitivity to components of atezolizumab
- Pregnancy, breastfeeding, or intention to become pregnant during or shortly after treatment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Antoni van Leeuwenhoek
Amsterdam, North Holland, Netherlands, 1066CX
Actively Recruiting
Research Team
M
Merel Lucassen, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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