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Recruiting NCT06553339

A Study of HS-10516 in Patients With VHL Syndrome Associated Tumors

Phase I Interventional Von Hippel Lindau-Deficient Clear Cell Renal Cell Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Oral HS-10516.
Who it may be relevant to
Registry conditions: Von Hippel Lindau-Deficient Clear Cell Renal Cell Carcinoma. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

This is a Phase Ia/Ib open label multicenter study of HS-10516 in Chinese patients aged 18 years or older with VHL Syndrome Associated Tumors. HS-10516 as a single agent, is administrated orally once daily. The aim of phase Ia, a dose escalation study, is to identify the MTD/MAD of HS-10516. The goal of Phase Ib, a dose expansion study, is to evaluate the safety, pharmacokinetics and antitumor efficacy of HS-10516.

Interventions

  • Drug Oral HS-10516
    Oral HIF-2α inhibitor

Primary outcome measures

  • Phase Ia: MTD/MAD of HS-10516 [Time frame: Approximately 2 months]
  • Phase Ib: Objective Response Rate (ORR) by Independent Review Committee (IRC) [Time frame: Approximately 1 year]
Secondary outcome measures (9)
  • The Number of Participants with Adverse Events [Time frame: Approximately 2 years]
  • Observed maximum plasma concentration (Cmax) of HS-10516 [Time frame: Approximately 2 months]
  • Time to reach maximum plasma concentration (Tmax) of HS-10516 [Time frame: Approximately 2 months]
  • Area under plasma concentration versus time curve from zero to last sampling time (AUC0-t) following the first dose of HS-10516 [Time frame: Approximately 1 year]
  • ORR by investigators/IRC per system [Time frame: Approximately 1 year]
  • Disease Control Rate (DCR) by investigators/IRC per system [Time frame: Approximately 1 year]
  • Duration of Response (DoR) by investigators/IRC per system [Time frame: Approximately 1 year]
  • Progression Free Survival (PFS) by investigators/IRC per system [Time frame: Approximately 2 years]
  • Overall Survival (OS) [Time frame: Approximately 2 years]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • Recieved 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 non-VHL syndrome associated 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 metabolin
  • Has any disease or condition would compromise subject safety or interfere with study assessments by investigator's decision

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Peking University First Hospital — Beijing

Identifiers

NCT: NCT06553339 · HS-10516-102

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗