RecruitingPhase 1NCT06553339
A Study of HS-10516 in Patients With VHL Syndrome Associated Tumors
A Phase I Study of HS-10516 in Patients With VHL Syndrome Associated Tumors，to Investigate Safety, Tolerance, Pharmacokinetic and Efficacy
Sponsor
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Enrollment
60 participants
Start Date
Jul 19, 2024
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 YearsMax Age: 80 Years
Inclusion Criteria7
- 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 Criteria16
- 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.
- Major surgery within 4 weeks prior to the first dose of study treatment.
- 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
Interventions
DRUGOral HS-10516
Oral HIF-2α inhibitor
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06553339