- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06049030
A Study of HS-10516 in Patients With Advanced Clear Cell Renal Cell Carcinoma
September 24, 2023 updated by: Jiangsu Hansoh Pharmaceutical Co., Ltd.
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
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.
Study Overview
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 Type
Interventional
Enrollment (Estimated)
190
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yun Chen
- Phone Number: +86 18652105250
- Email: cheny22@hspharm.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
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
- Has any disease or condition would compromise subject safety or interfere with study assessments by investigator's decision
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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
|
Oral HIF-2α inhibitor
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Approximately 2 months
|
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.
|
Approximately 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Approximately 2 years
|
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.
|
Approximately 2 months
|
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.
|
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
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.
|
Approximately 1 year
|
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.
|
Approximately 1 year
|
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.
|
Approximately 1 year
|
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.
|
Approximately 1 year
|
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.
|
Approximately 2 years
|
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.
|
Approximately 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jun Guo, M.D., Peking University Cancer Hospital & Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
September 25, 2023
Primary Completion (Estimated)
September 25, 2024
Study Completion (Estimated)
September 25, 2025
Study Registration Dates
First Submitted
September 15, 2023
First Submitted That Met QC Criteria
September 15, 2023
First Posted (Actual)
September 21, 2023
Study Record Updates
Last Update Posted (Actual)
September 26, 2023
Last Update Submitted That Met QC Criteria
September 24, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Kidney Neoplasms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Carcinoma, Renal Cell
- Carcinoma
Other Study ID Numbers
- HS-10516-101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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