LB-100 (PP2A Inhibitor) and Atezolizumab (PD-L1 Inhibitor) in Metastatic Colorectal Cancer Patients
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Netherlands Cancer Institute
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Measurable disease, per RECIST v1.1, must be present outside the CNS;
Trial design
Design model
Single group
Treatments tested in this trial
LB-100
DrugIV on day 1 and day 3
Atezolizumab
DrugIV on day 1
Treatment groups
37 Participants
are divided into 1 treatment groupGroup A: LB-100 plus atezolizumabExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
The RP2D of LB-100 when given in combination with standard doses of atezolizumab
Time frame
up to 2 yearsSecondary outcomes
1
Disease control rate
Measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame
6 months2
Objective response rate
Measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame
6 months3
Duration of overall response
Measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame
up to 2 years4
Progression free survival
Measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame
up to 2 yearsOther outcomes
1
Serine/threonine hyperphosphorylation in peripheral white blood cells
Western Blots to evaluate serine/threonine hyperphosphorylation in peripheral white blood cells
Time frame
Blood sample cycle 1 day 1. Each cycle is 21 days.2
Mismatch repair deficiency status
Immunohistochemistry for mismatch repair proteins
Time frame
Before start of treatment and one on treatment biopsy at Cycle 3 day 3. Each cycle is 21 days3
Concentration of LB-100 and endothall in tumor tissue
To evaluate pharmacodynamic biomarkers of LB-100
Time frame
On treatment biopsy at Cycle 3 day 3. Each cycle is 21 daysSponsors and contacts
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Source ClinicalTrials.gov