Trial · NCT06336707
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum tolerated dose (MTD) or maximum applicable dose (MAD) of HS-20089 in combination therapy | Up to day 21 from the first dose | To determine the MTD or MAD of HS-20089 in each combination therapy. |
| Secondary | Incidence and severity of adverse events (AEs) | From the first dose to 90 days after the end of treatment | AEs will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0. Incidence and severity of AEs are assessed according to vital signs, laboratory variables, physical examination, electrocardiogram, etc. |
| Secondary | Observed maximum plasma concentration (Cmax) of HS-20089 | From pre-dose to 14 days after the first dose of HS-20089 on Cycle 1 (each cycle is 21 days). | Cmax will be obtained following administration of the first dose of HS-20089 during the first cycle. |
| Secondary | Time to reach maximum plasma concentration (Tmax) of HS-20089 following the first dose | From pre-dose to 14 days after the first dose on Cycle 1 (each cycle is 21 days). | Tmax will be obtained following administration of the first dose of HS-20089 during the first cycle. |
| Secondary | Area under plasma concentration versus time curve from zero to last sampling time (AUC0-t) following the first dose of HS-20089 | From pre-dose to 14 days after the first dose on Cycle 1 (each cycle is 21 days). | Area under the plasma concentration versus time curve from time zero to the last sampling time when the concentration is no less than the lower limit of quantification (LLQ). AUC0-t will be calculated according to the mixed log-linear trapezoidal rule. |
| Secondary | Area under the plasma concentration versus time curve from time zero to infinity (AUC0-∞) after single dose of HS-20089 | From pre-dose to 14 days after the first dose on Cycle 1 (each cycle is 21 days). | AUC0-∞ will be calculated by combining AUC0-t and AUCextra. AUCextra represents an extrapolated value obtained by Clast/ λz, where Clast is the calculated plasma concentration at the last sampling time point at which the measured plasma concentration is at or above the LLQ and λz is the apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase. |
| Secondary | Objective response rate (ORR) assessed by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 | From the first dose up to disease progression or withdrawal from study, whichever came first (assessed up to 24 months). | ORR is defined as the percentage of participants who achieved a best overall response (BOR) of confirmed complete response (CR) or partial response (PR), assessed by investigators based on RECIST 1.1. |
| Secondary | Duration of response (DoR) assessed by investigators according to RECIST 1.1 | From the first dose to disease progression or withdrawal from study, whichever came first (assessed up to 24 months). | DoR is defined as the period from the first occurrence of CR or PR to progressive disease (PD) or death of any cause. If no PD or death after CR/PR, the cut-off date of progression-free survival (PFS) will be used. |
| Secondary | Disease control rate (DCR) assessed by investigators according to RECIST 1.1 | From the first dose to disease progression or withdrawal from study, whichever came first (assessed up to 24 months). | DCR is defined as the percentage of participants with BOR of confirmed CR, PR and stable disease (SD). |
| Secondary | Progression-free survival (PFS) assessed by investigators according to RECIST 1.1 | From the first dose or randomization to disease progression or withdrawal from study, whichever came first (assessed up to 24 months). | PFS is defined as the time from first dose or randomization (if any) to PD or death of any cause. |
| Secondary | Overall survival (OS) | From the first dose or randomization to death or withdrawal from study, whichever came first, assessed up to 24 months. | OS is defined as the time from the first dose or randomization (if any) to death of any cause. |
| Secondary | Percentage of participants with antibodies to HS-20089 in serum | From the first dose to 90 days after the end of treatment. | Serum samples will be collected for the determination of anti-drug antibody (ADA) at designated time points. |
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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