A Study of HS-10516 in Patients With VHL Syndrome Associated Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorJiangsu Hansoh Pharmaceutical Co., Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female from 18 to 80 year-old
Patients with advanced clear cellrenal cell carcinoma or von Hippel-Lindau Syndrome associated tumors
Has an Eastern Cooperative Oncology Group performance status of 0-1
Has a life expectancy of ≥ 12 weeks
Disqualifiers
Hypoxia-induced factor inhibitors
Traditional Chinese medicine indicated for tumors within 2 weeks prior to the first dose of study treatment.
Cytotoxic chemotherapeutic drugs, investigational drugs or other systematic anti-tumor therapies within 3 weeks before the first dose of study treatment
Colony-stimulating factors (CSFs) within 4 weeks before the first dose of study treatment
Trial design
Design model
Sequential
Treatments tested in this trial
Oral HS-10516
DrugOral HIF-2α inhibitor
Treatment groups
60 Participants
are divided into 4 treatment groupsGroup A: Phase Ia dose escalation armExperimental treatment 1 intervention
Group B: Phase Ib dose expansion arm 1Experimental treatment 1 intervention
Group C: Phase Ib dose expansion arm 2Experimental treatment 1 intervention
Group D: Phase Ib dose expansion arm 3Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Approximately 2 months2
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.
Time frame
Approximately 1 yearSecondary outcomes
1
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.
Time frame
Approximately 2 years2
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.
Time frame
Approximately 2 months3
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.
Time frame
Approximately 2 months4
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.
Time frame
Approximately 1 yearSponsors and contacts
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Source ClinicalTrials.gov