The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06049030
Recruitment Status : Not yet recruiting
First Posted : September 21, 2023
Last Update Posted : September 26, 2023
Sponsor:
Information provided by (Responsible Party):
Jiangsu Hansoh Pharmaceutical Co., Ltd.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Drug: HS-10516 Phase 1

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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 190 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase Ia/Ib Study of HS-10516 to Investigate the Safety, Tolerance, Pharmacokinetic and Efficacy in Patients With Advanced Clear Cell Renal Cell Carcinoma
Estimated Study Start Date : September 25, 2023
Estimated Primary Completion Date : September 25, 2024
Estimated Study Completion Date : September 25, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Phase Ia dose escalation
Participants will be assigned to pre-specified dose level to identify the MTD/MAD of HS-10516.
 Drug: HS-10516
Oral HIF-2α inhibitor
Experimental: 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
 Drug: HS-10516
Oral HIF-2α inhibitor


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Phase Ia: MTD/MAD of HS-10516 [ Time Frame: Approximately 2 months ]
    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

  2. Phase Ib: Objective Response Rate (ORR) by Independent Review Committee (IRC) [ Time Frame: Approximately 1 year ]
    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.


Secondary Outcome Measures :
  1. The Number of Participants with Adverse Events [ Time Frame: Approximately 2 years ]
    An adverse event (AE) is defined as any untoward medical occurrence in a patient and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related.

  2. Observed maximum plasma concentration (Cmax) of HS-10516 [ Time Frame: Approximately 2 months ]
    Cmax will be obtained following administration of the first dose of HS-10516 during first 2 cycles.

  3. Time to reach maximum plasma concentration (Tmax) of HS-10516 [ Time Frame: Approximately 2 months ]
    Tmax will be obtained following administration of the first dose of HS-10516 during first 2 cycles.

  4. Area under plasma concentration versus time curve from zero to last sampling time (AUC0-t) following the first dose of HS-10516 [ Time Frame: Approximately 1 year ]
    Area under the plasma concentration versus time curve from time zero to the last sampling time when the concentration was no less than the lower limit of quantification (LLQ). AUC0-t was calculated according to the mixed log-linear trapezoidal rule.

  5. ORR by investigators [ Time Frame: Approximately 1 year ]
    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.

  6. Disease Control Rate (DCR) [ Time Frame: Approximately 1 year ]
    DCR defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) or a stable disease (SD) of 8 weeks or longer based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

  7. Duration of Response (DoR) [ Time Frame: Approximately 1 year ]
    DoR is defined as the time from the date of first documented CR or PR, assessed by investigator and based on RECIST v. 1.1, to the documented date of progressive disease (PD) or death, whichever occurred first.

  8. Progression Free Survival (PFS) [ Time Frame: Approximately 2 years ]
    PFS defined as the time from the date the participant started study drug to the date the participant experiences an event of disease progression or death.

  9. Overall Survival (OS) [ Time Frame: Approximately 2 years ]
    OS defined as the time from the date the participant started study drug to death for any reason.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06049030


Contacts
Layout table for location contacts
Contact: Yun Chen +86 18652105250 cheny22@hspharm.com

Sponsors and Collaborators
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Investigators
Layout table for investigator information
Principal Investigator: Jun Guo, M.D. Peking University Cancer Hospital & Institute
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Jiangsu Hansoh Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT06049030    
Other Study ID Numbers: HS-10516-101
First Posted: September 21, 2023    Key Record Dates
Last Update Posted: September 26, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jiangsu Hansoh Pharmaceutical Co., Ltd.:
Advanced Clear Cell Renal Cell Carcinoma
Kidney Cancer
Renal Cancer
Recurrent Renal Cell Carcinoma
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney 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