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

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Hansoh Pharma

Status and phase

Enrolling
Phase 1

Conditions

Von Hippel Lindau-Deficient Clear Cell Renal Cell Carcinoma

Treatments

Drug: Oral HS-10516

Study type

Interventional

Funder types

Industry

Identifiers

NCT06553339
HS-10516-102

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

60 participants in 4 patient groups

Phase Ia dose escalation arm
Experimental group
Description:
Participants will be assigned to pre-specified dose level to identify the MTD/MAD of HS-10516.
Treatment:
Drug: Oral HS-10516
Phase Ib dose expansion arm 1
Experimental group
Description:
Participants with VHL Syndrome associated RCC, whose lesions diameter ≤ 3 cm.
Treatment:
Drug: Oral HS-10516
Phase Ib dose expansion arm 2
Experimental group
Description:
Participants with VHL Syndrome associated RCC, who could not be included in arm 1.
Treatment:
Drug: Oral HS-10516
Phase Ib dose expansion arm 3
Experimental group
Description:
Participants with VHL Syndrome associated non-RCC tumors.
Treatment:
Drug: Oral HS-10516

Trial contacts and locations

1

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Central trial contact

Kan Gong, PhD

Data sourced from clinicaltrials.gov

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