A Study of HS-10516 in Patients With VHL Syndrome Associated Tumors (NCT06553339) | Clinical Trial Compass
RecruitingPhase 1
A Study of HS-10516 in Patients With VHL Syndrome Associated Tumors
China60 participantsStarted 2024-07-19
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. 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
✓. Should use adequate contraceptive measures throughout the study
✓. Females subject must not be pregnant at screening
✓. Has the ability to understand and willingness to sign a written informed consent before the performance of the study.
Exclusion criteria
✕. Recieved or being received treatment as follows:
✕. 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
✕. Local radiotherapy within 2 weeks prior to the first dose of study treatment; more than 30% of bone marrow radiotherapy or large-area irradiation within 4 weeks before the first dose of study treatment.