A Phase I Study of HS-10516 in Patients With VHL Syndrome Associated Tumors，to Investigate Safety, Tolerance, Pharmacokinetic and Efficacy
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
Peking University First Hospital
RECRUITING
Beijing
Contact Information
Primary
Kan Gong, PhD
kan.gong@bjmu.edu.cn
13910394281
Time Frame
Start Date: 2024-07-19
Estimated Completion Date: 2028-07-31
Participants
Target number of participants: 60
Treatments
Experimental: Phase Ia dose escalation arm
Participants will be assigned to pre-specified dose level to identify the MTD/MAD of HS-10516.
Experimental: Phase Ib dose expansion arm 1
Participants with VHL Syndrome associated RCC, whose lesions diameter ≤ 3 cm.
Experimental: Phase Ib dose expansion arm 2
Participants with VHL Syndrome associated RCC, who could not be included in arm 1.
Experimental: Phase Ib dose expansion arm 3
Participants with VHL Syndrome associated non-RCC tumors.
Related Therapeutic Areas
Sponsors
Leads: Jiangsu Hansoh Pharmaceutical Co., Ltd.