Trial · NCT06012734
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The RP2D of LB-100 when given in combination with standard doses of atezolizumab | up to 2 years | |
| Secondary | Disease control rate | 6 months | Measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 |
| Secondary | Objective response rate | 6 months | Measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 |
| Secondary | Duration of overall response | up to 2 years | Measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 |
| Secondary | Progression free survival | up to 2 years | Measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 |
| Secondary | Overall survival | Assessed 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). |
| Secondary | Observed plasma concentrations of LB-100, its active metabolite endothall and atezolizumab | 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 | Blood samples are obtained and plasma concentrations of LB-100, endothall and atezolizumab are measured |
| Secondary | Area under the plasma-time concentration curve of LB-100, its active metabolite endothall and atezolizumab | 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 | Blood samples are obtained and plasma concentrations of LB-100, endothall and atezolizumab are measured |
| Secondary | Elimination half-life of LB-100, its active metabolite endothall and atezolizumab | 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 | Blood samples are obtained and plasma concentrations of LB-100, endothall and atezolizumab are measured |
| Secondary | Total body clearance of LB-100, its active metabolite endothall and atezolizumab | 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 | Blood samples are obtained and plasma concentrations of LB-100, endothall and atezolizumab are measured |
| Secondary | The incidence and severity of adverse events | Up to 2 years | As assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 |
| Secondary | The incidence of dose-limiting toxicity | 21 days | As assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 |
| Other | Serine/threonine hyperphosphorylation in peripheral white blood cells | Blood sample cycle 1 day 1. Each cycle is 21 days. | Western Blots to evaluate serine/threonine hyperphosphorylation in peripheral white blood cells |
| Other | Mismatch repair deficiency status | Before start of treatment and one on treatment biopsy at Cycle 3 day 3. Each cycle is 21 days | Immunohistochemistry for mismatch repair proteins |
| Other | Concentration of LB-100 and endothall in tumor tissue | On treatment biopsy at Cycle 3 day 3. Each cycle is 21 days | To 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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GET https://conductscience.org/api/trials/v1/NCT06012734/registered