A Study of HS-10516 in Patients With Advanced Clear Cell Renal Cell Carcinoma

NCT ID: NCT06049030

Last Updated: 2023-09-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 190 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-25
• Study Completion Date: 2025-09-25

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 ccRCC.

Detailed Description

This is a Phase Ia/Ib open label multicenter study of HS-10516 in Chinese patients aged 18 years or older with advanced clear cell renal cell carcinoma who have failed or are unavailable/intolerant to standard of care. 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

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

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

Group Type: EXPERIMENTAL

HS-10516

Intervention Type: DRUG

Oral HIF-2α inhibitor

Phase Ib dose expansion arm

Participants will be assigned to the recommended dose level determined in Phase Ia to evaluate the safety, pharmacokinetics and antitumor efficacy of HS-10516

Group Type: EXPERIMENTAL

HS-10516

Intervention Type: DRUG

Oral HIF-2α inhibitor

Interventions

HS-10516

Oral HIF-2α inhibitor

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male or female from 18 to 75 year-old

2. Histologically confirmed locally advanced or metastasis clear cell renal cell carcinoma whose standard treatment failed or proven unavailable or intolerant

3. Has at least one non-CNS target lesion per RESIST v1.1

4. Has an Eastern Cooperative Oncology Group performance status of 0-1

5. Has a life expectancy of ≥ 12 weeks

6. Should use adequate contraceptive measures throughout the study

7. Females subject must not be pregnant at screening

8. Has the ability to understand and willingness to sign a written informed consent before the performance of the study

Exclusion Criteria

1. Received 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 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 metabolics

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: 75 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

Jun Guo, M.D.

Role: PRINCIPAL_INVESTIGATOR

Peking University Cancer Hospital & Institute

Central Contacts

Yun Chen

Role: CONTACT

cheny22@hspharm.com

+86 18652105250

Other Identifiers

HS-10516-101

Identifier Type: -

Identifier Source: org_study_id