Testing HS-10516 for tumors related to VHL Syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: kan.gong@bjmu.edu.cn
• Phone: 13910394281

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.