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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.
Full description
This is a Phase Ia/Ib open label multicenter study of HS-10516 in Chinese patients aged 18 years or older with VHL Syndrome Associated Tumors. HS-10516 as a single agent, is administrated orally once daily. The aim of phase Ia, a dose escalation study, is to identify the MTD/MAD of HS-10516. The goal of Phase Ib, a dose expansion study, is to evaluate the safety, pharmacokinetics and antitumor efficacy of HS-10516.
Enrollment
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Inclusion criteria
Exclusion criteria
Recieved or being received treatment as follows:
Has a pulse oximetry reading less than 92% at screening, requires intermittent supplemental oxygen, or requires chronic supplemental oxygen
Has failed to recover from a ≥ grade 2 adverse event due to prior anti-tumor therapy
Has another malignancy or a history of another non-VHL syndrome associated malignancy
Has inadequate bone marrow reserve or organ dysfunction
Has a clinically significant bleeding events or tendency within 1 month prior to the first dose of study treatment
Has severe infections within 4 weeks prior to the first dose of study treatment
Has digestive system diseases may influencing ADME of study drug
Has a history of severe hypersensitivity reaction, or proven allergic to HS-10516 or its metabolin
Has any disease or condition would compromise subject safety or interfere with study assessments by investigator's decision
Primary purpose
Allocation
Interventional model
Masking
60 participants in 4 patient groups
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Central trial contact
Kan Gong, PhD
Data sourced from clinicaltrials.gov
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