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

NCT ID: NCT06553339

Last Updated: 2024-08-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-19
• Study Completion Date: 2028-07-31

Brief Summary

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.

Conditions

Von Hippel Lindau-Deficient Clear Cell Renal Cell Carcinoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phase Ia dose escalation arm

Participants will be assigned to pre-specified dose level to identify the MTD/MAD of HS-10516.

Group Type: EXPERIMENTAL

Oral HS-10516

Intervention Type: DRUG

Oral HIF-2α inhibitor

Phase Ib dose expansion arm 1

Participants with VHL Syndrome associated RCC, whose lesions diameter ≤ 3 cm.

Group Type: EXPERIMENTAL

Oral HS-10516

Intervention Type: DRUG

Oral HIF-2α inhibitor

Phase Ib dose expansion arm 2

Participants with VHL Syndrome associated RCC, who could not be included in arm 1.

Group Type: EXPERIMENTAL

Oral HS-10516

Intervention Type: DRUG

Oral HIF-2α inhibitor

Phase Ib dose expansion arm 3

Participants with VHL Syndrome associated non-RCC tumors.

Group Type: EXPERIMENTAL

Oral HS-10516

Intervention Type: DRUG

Oral HIF-2α inhibitor

Interventions

Oral HS-10516

Oral HIF-2α inhibitor

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu Hansoh Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kan Gong, PhD

Role: PRINCIPAL_INVESTIGATOR

Peking University First Hospital

Locations

Peking University First Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Kan Gong, PhD

Role: CONTACT

kan.gong@bjmu.edu.cn

13910394281

Facility Contacts

Kan Gong, PhD

Role: primary

kan.gong@bjmu.edu.cn

(0086)13910394281

Other Identifiers

HS-10516-102

Identifier Type: -

Identifier Source: org_study_id