Trial · NCT06332170
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum tolerated dose (MTD) for combination-treatments | Up to day 21 from the first dose | To determine the MTD for further evaluation of HS-20093 with other anti-cancer agents in subjects with advanced solid tumors |
| Secondary | Incidence and severity of adverse events (AEs) | From the first dose through 90 days post end of treatment | AE assessed by investigator exclusively related to subject's underlying disease or medical condition \[graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0\]. Any untoward medical occurrence in a clinical study participant, whether or not considered related to the medicinal product. Incidence and severity of AEs are assessed according to vital signs, laboratory variables, physical examination, electrocardiogram, etc. |
| Secondary | Objective response rate (ORR) determined by investigators | From the first dose up to PD or withdrawal from study, whichever came first, assessed up to 24 months | Objective tumor response for target lesions will be assessed by imaging/measurement compared with the overall tumor burden at baseline. ORR is evaluated by the number of participants with best overall response of CR and PR (Confirmed CR/PR assessment require at least 1 repeat). For prostate cancer patients, ORR is determined by investigators according to RECIST 1.1 and Prostate Cancer Working Group 3 (PCWG3). |
| Secondary | Disease control rate (DCR) determined by investigators | From the first dose up to PD or withdrawal from study, whichever came first, assessed up to 24 months | Objective tumor response for target lesions will be assessed by imaging/measurement compared with the overall tumor burden at baseline. DCR was evaluated by the number of participants with best overall response of CR, PR and stable disease (SD) \[Confirmed CR/PR assessment require at least one repeat (≥4 weeks); SD shall be assessed at least 5 weeks after the first dose\]. For prostate cancer patients, DCR is determined by investigators according to RECIST 1.1 and Prostate Cancer Working Group 3 (PCWG3). |
| Secondary | Duration of response (DoR) determined by investigators | From the first dose up to PD or death, whichever came first, assessed up to 24 months | DoR was defined as the period from the first occurrence of CR or PR to PD or death from any cause. If no PD or death after CR/PR, the cut-off date of progression-free survival (PFS) would be used \[Confirmed CR/PR assessment require at least one repeat (≥4 weeks)\]. For prostate cancer patients, DoR is determined by investigators according to RECIST 1.1 and Prostate Cancer Working Group 3 (PCWG3). |
| Secondary | Progression-free survival (PFS) determined by investigators according to RECIST 1.1 | From the first dose up to PD or death, whichever came first, assessed up to 24 months | PFS was defined as the time from random assignment or first dose to PD or death from any cause. |
| Secondary | Overall survival (OS) | From the first dose up to death, whichever came first, assessed up to 24 months | OS was defined as the time from random assignment or first dose to death from any cause. |
| Secondary | Radiographic progression-free survival (rPFS) determined by investigators according to RECIST 1.1 and PCWG3 | From the first dose up to PD or death from study, whichever came first, assessed up to 24 months | For prostate cancer patients, the rPFS is defined as the time from random assignment or first dose to the date of first documented PD per PCWG3 or death from any cause, whichever occurs first. |
| Secondary | Time to PSA progression (TTPP) | From the first dose up to PD or withdrawal from study, whichever came first, assessed up to 24 months | In participants with a decrease in PSA from baseline: ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the nadir value, which is confirmed by a consecutive second value obtained ≥ 3 weeks later. In participants with no decrease in PSA from baseline: ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the baseline value after 12 weeks. |
| Secondary | Prostate-specific cancer antigen (PSA) response rate | From the first dose up to PD or withdrawal from study, whichever came first, assessed up to 24 months | PSA response is defined as a ≥ 50% decline in PSA from baseline with PSA confirmation ≥ 3 weeks after the first documented reduction in PSA of ≥ 50%. |
| Secondary | Time to first subsequent therapy (TFST) | From the first dose up to the imitation of subsequent therapy or death, whichever came first, assessed up to 24 months | TFST was defined as the time from random assignment or first dose to the imitation of subsequent therapy or death. |
| Secondary | Observed maximum plasma concentration (Cmax) of HS-20093advanced solid tumor | From pre-dose to study completion, assessed up to 24 months | Cmax will be obtained after administration of the first dose of HS-20093 |
| Secondary | Time to reach maximum plasma concentration (Tmax) of HS-20093 | From pre-dose to study completion, assessed up to 24 months | Tmax will be obtained after administration of the first dose of HS-20093 |
| Secondary | Terminal half-life (T1/2) of HS-20093 following the first dose | From pre-dose to study completion, assessed up to 24 months | T1/2 will be obtained after administration of the first dose of HS-20093 |
| Secondary | Area under plasma concentration versus time curve from zero to last sampling time (AUC0-t) following the first dose of HS-20093 | From pre-dose to study completion, assessed up to 24 months | Area under the plasma concentration versus time curve from time zero to the last sampling time when the concentration was no less than the lower limit of quantification (LLQ). AUC0-t was calculated according to the mixed log-linear trapezoidal rule. |
| Secondary | Percentage of participants with antibodies to HS-20093 in serum | From pre-dose to study completion, assessed up to 24 months | Serum samples were 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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