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

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