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

Hansoh Pharma

Status and phase: Not yet enrolling; Phase 1

Conditions: Renal Cell Carcinoma

Treatments: Drug: HS-10516

Study type: Interventional

Funder types: Industry

Identifiers

NCT06049030

HS-10516-101

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 ccRCC.

Full 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.

Enrollment: 190 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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190 participants in 2 patient groups

Phase Ia dose escalation

Experimental group

Description:

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

Treatment:

Drug: HS-10516

Phase Ib dose expansion arm

Experimental group

Description:

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

Treatment:

Drug: HS-10516