Trial · NCT04560972
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Recommended phase II dose (RP2D) | End of first cycle (21 days) | Measured using dose-limiting toxicity (DLT) during the first cycle as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. |
| Secondary | Objective response rate (ORR) | Up to 2 years | Measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Patients who respond to treatment and die without progressive disease (PD) (including death from study disease), duration of response will be censored at the date of the last objective progression-free disease assessment. For responding patients not known to have died as of the data cut-off date and who do not have PD, duration of response will be censored at the last progression-free assessment date. For responding patients who receive subsequent anticancer therapy (after discontinuation from all study treatment excluding PCI) prior to disease progression, duration of response will be censored at the date of last progression-free assessment prior to the initiation of post discontinuation anticancer therapy. |
| Secondary | Duration of overall response | Up to 2 years | Measured by RECIST v1.1. |
| Secondary | Incidence of safety and adverse events | Up to 2 years | Assessed by CTCAE version 5.0. |
| Secondary | Progression-free survival (PFS) | Up to 2 years | As defined by RECIST v1.1. |
| Secondary | Overall survival (OS) | Time from the date of study enrollment to the date of death from any cause, assessed up to 2 years | OS which is defined as the time from the date of study enrollment to the date of death from any cause. For patients who are still alive as of the data cutoff date, OS time will be censored on the date of the patient's last contact (last contact for patients in post discontinuation is last known alive date in mortality status). |
| Other | Cmax of LB-100 | Cycle 1 day 1: Pre-dose, immediately post LB-100 infusion, at 15 & 30 minutes, at 1, 2, 4, and 8 hours post LB-100 infusion (Each cycle is 21 days); Cycle 1, days 2-3: Pre-dose and 24 hours post LB-100 infusion (Each cycle is 21 days)] | Plasma sampling for pharmacokinetic (PK) measurements of LB-100 will be performed . Blood samples will be collected to determine the Cmax of LB-100. |
| Other | Cmax of endothall | Cycle 1 day 1: Pre-dose, immediately post LB-100 infusion, at 15 & 30 minutes, at 1, 2, 4, and 8 hours post LB-100 infusion (Each cycle is 21 days); Cycle 1, days 2-3: Pre-dose and 24 hours post LB-100 infusion (Each cycle is 21 days)] | Plasma sampling for pharmacokinetic (PK) measurements of endothall, the metabolite of LB-100, will be performed . Blood samples will be collected to determine the Cmax of endothall. |
| Other | Tmax of LB-100 | Cycle 1 day 1: Pre-dose, immediately post LB-100 infusion, at 15 & 30 minutes, at 1, 2, 4, and 8 hours post LB-100 infusion (Each cycle is 21 days); Cycle 1, days 2-3: Pre-dose and 24 hours post LB-100 infusion (Each cycle is 21 days)] | Plasma sampling for pharmacokinetic (PK) measurements of LB-100 will be performed . Blood samples will be collected to determine the Tmax of LB-100. |
| Other | Tmax of endothall | Cycle 1 day 1: Pre-dose, immediately post LB-100 infusion, at 15 & 30 minutes, at 1, 2, 4, and 8 hours post LB-100 infusion (Each cycle is 21 days); Cycle 1, days 2-3: Pre-dose and 24 hours post LB-100 infusion (Each cycle is 21 days)] | Plasma sampling for pharmacokinetic (PK) measurements of endothall, the metabolite of LB-100, will be performed . Blood samples will be collected to determine the Tmax of endothall. |
| Other | t1/2 of LB-100 | Cycle 1 day 1: Pre-dose, immediately post LB-100 infusion, at 15 & 30 minutes, at 1, 2, 4, and 8 hours post LB-100 infusion (Each cycle is 21 days); Cycle 1, days 2-3: Pre-dose and 24 hours post LB-100 infusion (Each cycle is 21 days)] | Plasma sampling for pharmacokinetic (PK) measurements of LB-100 will be performed . Blood samples will be collected to determine the t1/2 of LB-100. |
| Other | t1/2 of endothall | [Time Frame: Cycle 1 day 1: Pre-dose, immediately post LB-100 infusion, at 15 & 30 minutes, at 1, 2, 4, and 8 hours post LB-100 infusion (Each cycle is 21 days); Cycle 1, days 2-3: Pre-dose and 24 hours post LB-100 infusion (Each cycle is 21 days)] | Plasma sampling for pharmacokinetic (PK) measurements of endothall, the metabolite of LB-100, will be performed . Blood samples will be collected to determine the t1/2 of endothall. |
| Other | AUC0-t of LB-100 | Cycle 1 day 1: Pre-dose, immediately post LB-100 infusion, at 15 & 30 minutes, at 1, 2, 4, and 8 hours post LB-100 infusion (Each cycle is 21 days); Cycle 1, days 2-3: Pre-dose and 24 hours post LB-100 infusion (Each cycle is 21 days)] | Plasma sampling for pharmacokinetic (PK) measurements of LB-100 will be performed . Blood samples will be collected to determine the AUC0-t of LB-100. |
| Other | AUC0-t of endothall | Cycle 1 day 1: Pre-dose, immediately post LB-100 infusion, at 15 & 30 minutes, at 1, 2, 4, and 8 hours post LB-100 infusion (Each cycle is 21 days); Cycle 1, days 2-3: Pre-dose and 24 hours post LB-100 infusion (Each cycle is 21 days)] | Plasma sampling for pharmacokinetic (PK) measurements of endothall, the metabolite of LB-100, will be performed . Blood samples will be collected to determine the AUC0-t of endothall. |
| Other | CL of LB-100 | Cycle 1 day 1: Pre-dose, immediately post LB-100 infusion, at 15 & 30 minutes, at 1, 2, 4, and 8 hours post LB-100 infusion (Each cycle is 21 days); Cycle 1, days 2-3: Pre-dose and 24 hours post LB-100 infusion (Each cycle is 21 days)] | Plasma sampling for pharmacokinetic (PK) measurements of LB-100 will be performed . Blood samples will be collected to determine the CL of LB-100. |
| Other | CL of endothall | Cycle 1 day 1: Pre-dose, immediately post LB-100 infusion, at 15 & 30 minutes, at 1, 2, 4, and 8 hours post LB-100 infusion (Each cycle is 21 days); Cycle 1, days 2-3: Pre-dose and 24 hours post LB-100 infusion (Each cycle is 21 days)] | Plasma sampling for pharmacokinetic (PK) measurements of endothall, the metabolite of LB-100, will be performed . Blood samples will be collected to determine the CL of endothall. |
| Other | Relative abundance of immune cell populations | Up to 2 years] | The signaling states that evolve in immune cells during treatment and that differentiate responders from nonresponders. Number of effector memory T cells Number of classical monocytes |
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.
For software
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GET https://conductscience.org/api/trials/v1/NCT04560972/registered