Status:
UNKNOWN
A Study of HS-10516 in Patients With Advanced Clear Cell Renal Cell Carcinoma
Lead Sponsor:
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Conditions:
Renal Cell Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief 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 ccR...
Detailed Description
This is a Phase Ia/Ib open label multicenter study of HS-10516 in Chinese patients aged 18 years or older with advanced clear cell renal cell carcinoma who have failed or are unavailable/intolerant to...
Eligibility Criteria
Inclusion
- Male or female from 18 to 75 year-old
- Histologically confirmed locally advanced or metastasis clear cell renal cell carcinoma whose standard treatment failed or proven unavailable or intolerant
- Has at least one non-CNS target lesion per RESIST v1.1
- 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
- Received 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 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 metabolics
- Has any disease or condition would compromise subject safety or interfere with study assessments by investigator's decision
Key Trial Info
Start Date :
September 25 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 25 2025
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT06049030
Start Date
September 25 2023
End Date
September 25 2025
Last Update
September 26 2023
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