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

• Status: Not yet recruiting
• Trial end date: 2025-09-25
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

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