Metastatic Microsatellite-stable Colorectal CancerPhase 1CoLBAtNCT06012734
LB-100 (PP2A Inhibitor) and Atezolizumab (PD-L1 Inhibitor) in Metastatic Colorectal Cancer Patients
A Phase 1 study testing LB-100 and Atezolizumab in people with Metastatic Microsatellite-stable Colorectal Cancer, run by The Netherlands Cancer Institute at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Microsatellite-stable Colorectal Cancer
- What is being tested?
- LB-100 and Atezolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteNetherlands
- Study dates
- 18 Jun 2024to Jul 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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;
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- 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.
Who cannot join
- 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;
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- 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 within 28 days prior to initiation of study treatment;
- 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 radiation field is permitted;
- 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, unstable arrhythmia, or unstable angina;
- 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., 5-year OS rate >90%);
- 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 the patient at high risk from treatment complications;
- 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 atezolizumab;
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Antoni van Leeuwenhoek
Amsterdam, North Holland, 1066CX
M Lucassen, MD
About this study
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
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.
Read the detailed description
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.
- Being tested
- LB-100, Atezolizumab
- Keywords
- Gastrointestinal Neoplasms, Colorectal cancer, Metastatic colorectal cancer, Microsatellite stable, Immune checkpoint inhibitors
- Medical subject headings
- Gastrointestinal Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LB-100Drug
Also called PP2A inhibitor LB-100
IV on day 1 and day 3
AtezolizumabDrug
Also called Tecentriq
IV on day 1
| Study group | Role | What they receive |
|---|---|---|
| LB-100 plus atezolizumab | Experimental | 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 Receives: Drug: LB-100; Drug: Atezolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The RP2D of LB-100 when given in combination with standard doses of atezolizumab
Measured: up to 2 years
Secondary outcomes (11)
Disease control rate
Measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Measured: 6 months
Objective response rate
Measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Measured: 6 months
Duration of overall response
Measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Measured: up to 2 years
Progression free survival
Measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Measured: up to 2 years
Overall survival
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).
Measured: Assessed up to 2 years
Observed plasma concentrations of LB-100, its active metabolite endothall and atezolizumab
Blood samples are obtained and plasma concentrations of LB-100, endothall and atezolizumab are measured
Measured: 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
Area under the plasma-time concentration curve of LB-100, its active metabolite endothall and atezolizumab
Blood samples are obtained and plasma concentrations of LB-100, endothall and atezolizumab are measured
Measured: 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
Elimination half-life of LB-100, its active metabolite endothall and atezolizumab
Blood samples are obtained and plasma concentrations of LB-100, endothall and atezolizumab are measured
Measured: 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
Total body clearance of LB-100, its active metabolite endothall and atezolizumab
Blood samples are obtained and plasma concentrations of LB-100, endothall and atezolizumab are measured
Measured: 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
The incidence and severity of adverse events
As assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Measured: Up to 2 years
The incidence of dose-limiting toxicity
As assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start18 Jun 2024
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Microsatellite-stable Colorectal CancerStudies of the same condition, open and under way.
- More trials run by The Netherlands Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neeltje Steeghs, MD, PhD, Principal investigator, The Netherlands Cancer Institute - Antoni van Leeuwenhoek
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06012734
- Sponsor's protocol ID
- N22CLB
- Acronym
- CoLBAt
- Status last verified
- Jun 2026
- First submitted
- 21 Jul 2023
- Last updated
- 29 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06012734
- Acronym / sponsor ID
- CoLBAt / N22CLB
- Keywords
- Gastrointestinal Neoplasms, Colorectal cancer, Metastatic colorectal cancer, Microsatellite stable, Immune checkpoint inhibitors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Study start
- 18 Jun 2024 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 25 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LB-100 plus atezolizumab | Experimental | Drug: LB-100, Drug: AtezolizumabLB-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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- 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;
Key exclusion criteria (32 listed)
- 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:
- History of leptomeningeal disease;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LB-100Also: PP2A inhibitor LB-100IV on day 1 and day 3 | Drug | LB-100 plus atezolizumab |
| AtezolizumabAlso: TecentriqIV on day 1 | Drug | LB-100 plus atezolizumab |
Primary outcome
The RP2D of LB-100 when given in combination with standard doses of atezolizumab
Time frame: up to 2 years
11 secondary outcomes
Disease control rate
Time frame: 6 months
Objective response rate
Time frame: 6 months
Duration of overall response
Time frame: up to 2 years
Progression free survival
Time frame: up to 2 years
Overall survival
Time frame: Assessed up to 2 years
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
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
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
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
The incidence and severity of adverse events
Time frame: Up to 2 years
The incidence of dose-limiting toxicity
Time frame: 21 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Neeltje Steeghs, MD, PhD principal investigator
The Netherlands Cancer Institute - Antoni van Leeuwenhoek
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LB-100 and Atezolizumab in people with Metastatic Microsatellite-stable Colorectal Cancer, run by The Netherlands Cancer Institute at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 28 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Merel Lucassen, MD (+31205129111, me.lucassen@nki.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The RP2D of LB-100 when given in combination with standard doses of atezolizumab (time frame: up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.