Phase 1 Kidney Cancer Trial, Recruiting NCT06553339 Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. Condition: Kidney Cancer
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Phase 1 Kidney Cancer Trial, Recruiting

NCT06553339
Recruiting Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged 18 to 80 years old, of any gender
  • People diagnosed with advanced clear cell renal cell carcinoma (a type of kidney cancer) or tumors linked to a condition called von Hippel-Lindau (VHL) Syndrome
  • People who are generally well enough to carry out light activity or desk work, but may not be able to do heavy physical work (this is measured by a standard scale called ECOG, scores 0–1)
  • People expected to live for at least 12 weeks
  • People willing to use adequate birth control measures throughout the study
  • Women who are not pregnant at the time of screening
  • People who are able to understand and sign a written consent form before the study begins

Who may not be able to join:

  • People who have recently received certain treatments, including: hypoxia-inducible factor (HIF) inhibitors; traditional Chinese medicines used for tumours within the past 2 weeks; chemotherapy, experimental drugs, or other systemic anti-tumour therapies within the past 3 weeks; colony-stimulating factor injections within the past 4 weeks; local radiation therapy within the past 2 weeks, or extensive bone marrow or large-area radiation within the past 4 weeks; or major surgery within the past 4 weeks
  • People whose blood oxygen levels measured by a fingertip monitor were below 92% at screening, or who need extra oxygen either sometimes or continuously
  • People who have not yet recovered from significant side effects (grade 2 or higher) caused by a previous cancer treatment
  • People who have, or have had, another type of cancer not related to VHL Syndrome
  • People with poor bone marrow function or significant problems with how their organs (such as the liver or kidneys) are working
  • People who have had a significant bleeding event or a tendency to bleed heavily in the month before starting the study
  • People who have had a serious infection in the 4 weeks before starting the study
  • People with digestive system conditions that could affect how the study drug is absorbed, broken down, or removed by the body
  • People with a history of severe allergic reactions, or who are known to be allergic to the study drug (HS-10516) or its breakdown products
  • People with any other disease or condition that the study doctor believes could put them at risk or affect the reliability of the study results

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Kan Gong, PhD, Peking University First Hospital

Phone: 13910394281

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 1
Sponsor
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Registry
ClinicalTrials.gov
Start date
19 July 2024
Est. completion
31 July 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Phase Ia: MTD/MAD of HS-10516; Phase Ib: Objective Response Rate (ORR) by Independent Review Committee (IRC)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov