Von Hippel Lindau-Deficient Clear Cell Renal Cell Carcinoma
Investigational drug(s) / intervention(s)
Oral HS-10516
Oral HS-10516: Oral HIF-2α inhibitor
Study 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
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
1. Male or female from 18 to 80 year-old
2. Patients with advanced clear cellrenal cell carcinoma or von Hippel-Lindau Syndrome associated tumors
3. Has an Eastern Cooperative Oncology Group performance status of 0-1
4. Has a life expectancy of ≥ 12 weeks
5. Should use adequate contraceptive measures throughout the study
6. Females subject must not be pregnant at screening
7. Has the ability to understand and willingness to sign a written informed consent before the performance of the study.
Exclusion Criteria:
1. Recieved or being received treatment as follows:
1. Hypoxia-induced factor inhibitors
2. Traditional Chinese medicine indicated for tumors within 2 weeks prior to the first dose of study treatment.
3. Cytotoxic chemotherapeutic drugs, investigational drugs or other systematic anti-tumor therapies within 3 weeks before the first dose of study treatment
4. Colony-stimulating factors (CSFs) within 4 weeks before the first dose of study treatment
5. 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.
6. Major surgery within 4 weeks prior to the first dose of study treatment.
2. Has a pulse oximetry reading less than 92% at screening, requires intermittent supplemental oxygen, or requires chronic supplemental oxygen
3. Has failed to recover from a ≥ grade 2 adverse event due to prior anti-tumor therapy
4. Has another malignancy or a history of another non-VHL syndrome associated malignancy
5. Has inadequate bone marrow reserve or organ dysfunction
6. Has a clinically significant bleeding events or tendency within 1 month prior to the first dose of study treatment
7. Has severe infections within 4 weeks prior to the first dose of study treatment
8. Has digestive system diseases may influencing ADME of study drug
9. Has a history of severe hypersensitivity reaction, or proven allergic to HS-10516 or its metabolin
10. Has any disease or condition would compromise subject safety or interfere with study assessments by investigator's decision
Primary outcome measure(s)
Phase Ia: MTD/MAD of HS-10516 — Approximately 2 months 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
Phase Ib: Objective Response Rate (ORR) by Independent Review Committee (IRC) — Approximately 1 year 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.
Trial sites (1)
Facility
City
Region
Status
Peking University First Hospital
Beijing
Beijing Municipality
Recruiting
More Jiangsu Hansoh Pharmaceutical Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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