Testing HS-10516 for tumors related to VHL Syndrome

A Phase I Study of HS-10516 in Patients With VHL Syndrome Associated Tumors，to Investigate Safety, Tolerance, Pharmacokinetic and Efficacy

This study is testing a new medication called HS-10516 to see if it can help Chinese patients with tumors related to Von Hippel-Lindau Syndrome feel better and improve their treatment options.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. (industry)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06553339 on ClinicalTrials.gov

What this trial studies

This Phase Ia/Ib open-label multicenter study evaluates HS-10516 in Chinese patients aged 18 years or older with tumors associated with Von Hippel-Lindau Syndrome. The Phase Ia portion focuses on determining the maximum tolerated dose of HS-10516, while the Phase Ib portion assesses its preliminary efficacy, safety, and pharmacokinetics. Patients will receive HS-10516 orally once daily as a single agent. The study aims to provide insights into the treatment of advanced clear cell renal cell carcinoma and other related tumors.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with advanced clear cell renal cell carcinoma or VHL Syndrome associated tumors.

Not a fit: Patients who have recently received certain anti-tumor therapies or treatments that may interfere with HS-10516 will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with VHL Syndrome associated tumors.

How similar studies have performed: While this approach is novel for VHL Syndrome associated tumors, similar studies have shown promise in targeting specific tumor types with new agents.

Eligibility criteria

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

Where this trial is running

Beijing, Beijing Municipality

• Peking University First Hospital — Beijing, Beijing Municipality, China (RECRUITING)

Study contacts

• Principal investigator: Kan Gong, PhD — Peking University First Hospital
• Study coordinator: Kan Gong, PhD

Conditions: Von Hippel Lindau-Deficient Clear Cell Renal Cell Carcinoma, Von Hippel Lindau Syndrome, VHL Syndrome, RCC, pNET, CNS hemangioblastoma