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

NCT06049030 | Unknown Phase 1

• 1 other identifier: HS-10516-101
• Study Type: interventional
• Target: 190
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Renal Cell Carcinoma

Keywords

Advanced Clear Cell Renal Cell Carcinoma; Kidney Cancer; Renal Cancer; Recurrent Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (2)

• Phase Ia: MTD/MAD of HS-10516

  Maximum Tolerated Dose or Maximum Acceptable Dose determined by the Number of Participants with Dose Limiting Toxicity (DLT) events during the DLT monitoring period (first 35 days of dosing) in the Dose Escalation Phase

  Approximately 2 months

• Phase Ib: Objective Response Rate (ORR) by Independent Review Committee (IRC)

  ORR defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. ORR will be assessed by IRC.

  Approximately 1 year

Secondary Outcomes (9)

• The Number of Participants with Adverse Events

  Approximately 2 years

• Observed maximum plasma concentration (Cmax) of HS-10516

  Approximately 2 months

• Time to reach maximum plasma concentration (Tmax) of HS-10516

  Approximately 2 months

• Area under plasma concentration versus time curve from zero to last sampling time (AUC0-t) following the first dose of HS-10516

  Approximately 1 year

• ORR by investigators

  Approximately 1 year

Study Arms (2)

Phase Ia dose escalation

EXPERIMENTAL

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

Drug: HS-10516

Phase Ib dose expansion arm

EXPERIMENTAL

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

Drug: HS-10516

Interventions

HS-10516 DRUG

Oral HIF-2α inhibitor

Phase Ia dose escalation; Phase Ib dose expansion arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female from 18 to 75 year-old
• Histologically confirmed locally advanced or metastasis clear cell renal cell carcinoma whose standard treatment failed or proven unavailable or intolerant
• Has at least one non-CNS target lesion per RESIST v1.1
• Has an Eastern Cooperative Oncology Group performance status of 0-1
• Has a life expectancy of ≥ 12 weeks
• Should use adequate contraceptive measures throughout the study
• Females subject must not be pregnant at screening
• Has the ability to understand and willingness to sign a written informed consent before the performance of the study

You may not qualify if:

• Received or being received treatment as follows:
• Hypoxia-induced factor inhibitors
• Traditional Chinese medicine indicated for tumors within 2 weeks prior to the first dose of study treatment.
• Cytotoxic chemotherapeutic drugs, investigational drugs or other systematic anti-tumor therapies within 3 weeks before the first dose of study treatment
• Colony-stimulating factors (CSFs) within 4 weeks before the first dose of study treatment
• 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.
• Major surgery within 4 weeks prior to the first dose of study treatment.
• Has a pulse oximetry reading less than 92% at screening, requires intermittent supplemental oxygen, or requires chronic supplemental oxygen
• Has failed to recover from a ≥ grade 2 adverse event due to prior anti-tumor therapy
• Has another malignancy or a history of another malignancy
• Has inadequate bone marrow reserve or organ dysfunction
• Has a clinically significant bleeding events or tendency within 1 month prior to the first dose of study treatment
• Has severe infections within 4 weeks prior to the first dose of study treatment
• Has digestive system diseases may influencing ADME of study drug
• Has a history of severe hypersensitivity reaction, or proven allergic to HS-10516 or its metabolics

Sponsors & Collaborators

• Jiangsu Hansoh Pharmaceutical Co., Ltd.: lead

MeSH Terms

Conditions

Carcinoma, Renal Cell; Kidney Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Jun Guo, M.D.

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yun Chen

CONTACT

+86 18652105250; cheny22@hspharm.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2023
• First Posted: September 21, 2023
• Study Start: September 25, 2023
• Primary Completion: September 25, 2024
• Study Completion: September 25, 2025
• Last Updated: September 26, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share