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
Qualifiers
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
Treatments tested in this trial
- Oral HS-10516
Treatment groups
60 Participants
are divided into 4 treatment groupsLocations
1Peking University First Hospital100034, BeijingBeijing Municipality, China
Sponsors and collaborators
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Lead sponsor
Source ClinicalTrials.gov