A Study of HS-10516 in Patients With VHL Syndrome Associated Tumors
NCT Number: NCT06553339
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Von Hippel Lindau-Deficient Clear Cell Renal Cell Carcinoma
Interventions: DRUG: Oral HS-10516
Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-19
Completion Date: 2028-07-31
Locations: Peking University First Hospital, Beijing, Beijing, 100034, China

Summary:
The aim of the Phase Ia portion is to identify the maximum tolerated dose or maximum acceptable dose MTD/MAD of HS-10516. The phase Ib portion will evaluate the preliminary efficacy of HS-10516 in patients with VHL Syndrome Associated Tumors.

Primary Outcome Measures: Phase Ia: MTD/MAD of HS-10516, Maximum Tolerated Dose or Maximum Acceptable Dose determined by the Number of Participants with Dose Limiting Toxicity (DLT) events during the DLT monitoring period (first 35 days of dosing) in the Dose Escalation Phase, Approximately 2 months|Phase Ib: Objective Response Rate (ORR) by Independent Review Committee (IRC), ORR defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. ORR will be assessed by IRC., Approximately 1 year
Secondary Outcome Measures: The Number of Participants with Adverse Events, An adverse event (AE) is defined as any untoward medical occurrence in a patient and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related., Approximately 2 years|Observed maximum plasma concentration (Cmax) of HS-10516, Cmax will be obtained following administration of the first dose of HS-10516 during first 2 cycles., Approximately 2 months|Time to reach maximum plasma concentration (Tmax) of HS-10516, Tmax will be obtained following administration of the first dose of HS-10516 during first 2 cycles., Approximately 2 months|Area under plasma concentration versus time curve from zero to last sampling time (AUC0-t) following the first dose of HS-10516, 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., Approximately 1 year|ORR by investigators/IRC per system, ORR defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1., Approximately 1 year|Disease Control Rate (DCR) by investigators/IRC per system, DCR defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) or a stable disease (SD) of 8 weeks or longer based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1., Approximately 1 year|Duration of Response (DoR) by investigators/IRC per system, DoR is defined as the time from the date of first documented CR or PR, assessed by investigator and based on RECIST v. 1.1, to the documented date of progressive disease (PD) or death, whichever occurred first., Approximately 1 year|Progression Free Survival (PFS) by investigators/IRC per system, PFS defined as the time from the date the participant started study drug to the date the participant experiences an event of disease progression or death., Approximately 2 years|Overall Survival (OS), OS defined as the time from the date the participant started study drug to death for any reason., Approximately 2 years