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Trial · NCT06012734

Registered outcomes15

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryThe RP2D of LB-100 when given in combination with standard doses of atezolizumabup to 2 years
SecondaryDisease control rate6 monthsMeasured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
SecondaryObjective response rate6 monthsMeasured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
SecondaryDuration of overall responseup to 2 yearsMeasured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
SecondaryProgression free survivalup to 2 yearsMeasured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
SecondaryOverall survivalAssessed up to 2 years
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).
SecondaryObserved plasma concentrations of LB-100, its active metabolite endothall and atezolizumabPrior to initial dose, on day 1, day 2, day 3, day 8, day 15 and prior to second cycle. Each cycle is 21 daysBlood samples are obtained and plasma concentrations of LB-100, endothall and atezolizumab are measured
SecondaryArea under the plasma-time concentration curve of LB-100, its active metabolite endothall and atezolizumabPrior to initial dose, on day 1, day 2, day 3, day 8, day 15 and prior to second cycle. Each cycle is 21 daysBlood samples are obtained and plasma concentrations of LB-100, endothall and atezolizumab are measured
SecondaryElimination half-life of LB-100, its active metabolite endothall and atezolizumabPrior to initial dose, on day 1, day 2, day 3, day 8, day 15 and prior to second cycle. Each cycle is 21 daysBlood samples are obtained and plasma concentrations of LB-100, endothall and atezolizumab are measured
SecondaryTotal body clearance of LB-100, its active metabolite endothall and atezolizumabPrior to initial dose, on day 1, day 2, day 3, day 8, day 15 and prior to second cycle. Each cycle is 21 daysBlood samples are obtained and plasma concentrations of LB-100, endothall and atezolizumab are measured
SecondaryThe incidence and severity of adverse eventsUp to 2 yearsAs assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
SecondaryThe incidence of dose-limiting toxicity21 daysAs assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
OtherSerine/threonine hyperphosphorylation in peripheral white blood cellsBlood sample cycle 1 day 1. Each cycle is 21 days.Western Blots to evaluate serine/threonine hyperphosphorylation in peripheral white blood cells
OtherMismatch repair deficiency statusBefore start of treatment and one on treatment biopsy at Cycle 3 day 3. Each cycle is 21 daysImmunohistochemistry for mismatch repair proteins
OtherConcentration of LB-100 and endothall in tumor tissueOn treatment biopsy at Cycle 3 day 3. Each cycle is 21 daysTo evaluate pharmacodynamic biomarkers of LB-100

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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