Trial · NCT06769425
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum tolerated dose (MTD) of HS-10502（Stage 1：Dose escalating stage） | Cycle 1 (21 days) | MTD is defined as the previous dose level at which 2 or more out of 2-6 subjects experienced a DLT. |
| Primary | Maximum applicable dose (MAD) of HS-10502（Stage 1：Dose escalating stage） | Cycle 1 (21days) | MAD is defined as follows: a) based on PK data, it is anticipated that at this dose level, the dose-exposure plateau has been reached, b) based on existing safety data, it is judged that dose escalation following this dose level will have a large safety risk or subject intolerance, or c) based on the PK-PD model, it suggested that the optimal target concentration of safety and efficacy has been explored. |
| Primary | Efficacy of HS-10502: Objective response rate (ORR)（Stage 2： Dose expansion stage） | From the date of first dose until the date of disease progression or withdrawal from study, approximately 2 years | ORR is defined as the proportion of participants with BOR of confirmed CR or confirmed PR per RECIST v1.1 (applicable for all solid tumors except prostate cancer) or per RECIST v1.1 and PCWG3 (for prostate cancer only). |
| Secondary | Incidence and severity of treatment-emergent adverse events | From Cycle 1 Day 1 (C1D1) until 21 days after the final dose. A cycle is 21days. | Assessed by number and severity of adverse events as evaluated according to NCI CTCAE v5.0. |
| Secondary | PK parameters: The maximum observed concentration (Cmax) of HS-10502 | Cycle 1 Day 1 (each cycle is 21 days) | Defines as the maximum plasma drug concentration of HS-10502 |
| Secondary | PK parameters: time to Cmax (Tmax) of HS-10502 | Cycle 1 Day 1 (each cycle is 21 days) | Time of maximum observed concentration of HS-10502. |
| Secondary | PK parameters: area under the concentration-time curve from time 0 to time t of last measurable concentration (AUC0-t) of HS-10502. | Cycle 1 Day 1 (each cycle is 21 days) | Area under the curve from the time of dosing to the time of the last measurable (positive) concentration. |
| Secondary | PK parameters: Maximum plasma concentration at steady state (Css, max) of HS-10502 | Cycle 2 Day 1 (each cycle is 21 days) | Defines as the maximum plasma drug concentration at steady state of HS-10502. |
| Secondary | PK parameters: time to Css, max (Tss, max) of HS-10502 | Cycle 2 Day 1 (each cycle is 21 days) | Time of maximum observed concentration at steady state of HS-10502. |
| Secondary | PK parameters: Minimum plasma concentration at steady state (Css, min) of HS-10502 | Cycle 2 Day 1 (each cycle is 21 days) | Minimum plasma drug concentration at steady state of HS-10502. |
| Secondary | PK parameters: Area under the plasma concentration-time curve over a dosing interval at steady state (AUCss) of HS-10502 | Cycle 2 Day 1 (each cycle is 21days) | The partial area from dosing time to dosing time plus dosing interval of HS-10502. |
| Secondary | Efficacy of HS-10502: ORR | From the date of first dose until the date of disease progression or withdrawal from study, approximately 2 years | ORR is defined as the proportion of participants with BOR of confirmed CR or confirmed PR per RECIST v1.1 (applicable for all solid tumors except prostate cancer) or per RECIST v1.1 and PCWG3 (for prostate cancer only). |
| Secondary | Efficacy of HS-10502: disease control rate (DCR) | From the date of first dose until the date of disease progression or withdrawal from study, approximately 2 years | The disease control was defined as the percentage of patients who have a best overall response (confirmed CR, PR, or stable disease for at least 5 weeks) per RECIST v1.1 (applicable for all solid tumors except prostate cancer) or per RECIST v1.1 and PCWG3 (for prostate cancer only). |
| Secondary | Efficacy of HS-10502: duration of response (DoR) | From the date of CR, PR until the date of disease progression or withdrawal from study, approximately 2 years | DoR only applies to participants whose best overall response is CR or PR based on assessment per RECIST v1.1 (applicable for all solid tumors except prostate cancer) or per RECIST v1.1 and PCWG3 (for prostate cancer only). The start date is the date of first documented response of CR or PR (i.e. the start date of observed response, not the date when response was confirmed), and the end date is defined as the date of the first documented progression or death due to underlying cancer. |
| Secondary | Efficacy of HS-10502: progression free survival (PFS) (applicable for all solid tumors except prostate cancer) | From the date of randomization or first dose (if randomization is not needed) until the date of disease progression or withdrawal from study, approximately 2 years. | PFS is defined as the time from the date of randomization or first dose (if randomization is not needed) to the date of the first documented progression or death due to any cause. PFS will be assessed per RECIST v1.1. |
| Secondary | Efficacy of HS-10502: radiographic progression free survival (rPFS) (for prostate cancer only) | From the date of randomization or first dose (if randomization is not needed) until the date of disease progression or withdrawal from study, approximately 2 years. | rPFS is defined as the time from the date of randomization or first dose (if randomization is not needed) to the date of the first documented progression or death due to any cause. rPFS will be assessed per RECIST v1.1 (soft tissue) and PCWG3 (bone). |
| Secondary | Efficacy of HS-10502: ORR evaluated by RECIST v1.1 and GCIG CA-125 (for ovarian cancer only) | From the date of first dose until the date of disease progression or withdrawal from study, approximately 2 years | For ovarian cancer, ORR is defined as the proportion of participants with BOR of confirmed CR or confirmed PR per both RECIST v1.1 and GCIG CA-125 criteria. |
| Secondary | Efficacy of HS-10502: overall survival (OS) | From the date of randomization or first dose (if randomization is not needed) until the documentation of death from any cause, approximately 4 years | OS is defined as the time from the date of randomization or first dose (if randomization is not needed) to the date of death due to any cause. For each participant who is not known to have died as of the cutoff date for overall survival analysis, OS time was censored on the last date the participant is known to be alive. |
| Secondary | Efficacy of HS-10502: Proportion of subjects with CA-125 decreased by ≥ 50% from baseline (for ovarian cancer only) | From the date of first dose until the date of disease progression or withdrawal from study, approximately 2 years | The percentage of subjects (ovarian cancer only) with a reduction of at least 50% from baseline in CA-125 levels. |
| Secondary | Efficacy of HS-10502: PSA50 response rate (for prostate cancer only) | From the date of first dose until the date of disease progression or withdrawal from study, approximately 2 years | PSA50 response rate is defined as the proportion of subjects with a PSA nadir of ≤ 50% of baseline PSA level confirmed by serial PSA assessments (at least 3 weeks apart) after the start of the study. |
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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