Renal Cell CarcinomaPhase 1NCT06049030
A Study of HS-10516 in Patients With Advanced Clear Cell Renal Cell Carcinoma
A Phase 1 study testing HS-10516 in people with Renal Cell Carcinoma, run by Jiangsu Hansoh Pharmaceutical Co., Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Renal Cell Carcinoma
- What is being tested?
- HS-10516
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- No sites listed yet
- Study dates
- 25 Sep 2023to 25 Sep 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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.
- Conditions
- Renal Cell Carcinoma
- Being tested
- HS-10516
- Keywords
- Advanced Clear Cell Renal Cell Carcinoma, Kidney Cancer, Renal Cancer, Recurrent Renal Cell Carcinoma
- Medical subject headings
- Carcinoma, Renal Cell, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-10516Drug
Oral HIF-2α inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Phase Ia dose escalation | Experimental | Participants will be assigned to pre-specified dose level to identify the MTD/MAD of HS-10516. Receives: 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 Receives: Drug: HS-10516 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Approximately 1 year
Secondary outcomes (9)
The Number of Participants with Adverse Events
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.
Measured: Approximately 2 years
Observed maximum plasma concentration (Cmax) of HS-10516
Cmax will be obtained following administration of the first dose of HS-10516 during first 2 cycles.
Measured: Approximately 2 months
Time to reach maximum plasma concentration (Tmax) of HS-10516
Tmax will be obtained following administration of the first dose of HS-10516 during first 2 cycles.
Measured: 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
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.
Measured: Approximately 1 year
ORR by investigators
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.
Measured: Approximately 1 year
Disease Control Rate (DCR)
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.
Measured: Approximately 1 year
Duration of Response (DoR)
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.
Measured: Approximately 1 year
Progression Free Survival (PFS)
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.
Measured: Approximately 2 years
Overall Survival (OS)
OS defined as the time from the date the participant started study drug to death for any reason.
Measured: Approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start25 Sep 2023 (estimated)
- Primary completion25 Sep 2024 (estimated)
- Study completion25 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Jiangsu Hansoh Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jun Guo, M.D., Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06049030
- Sponsor's protocol ID
- HS-10516-101
- Status last verified
- Sep 2023
- First submitted
- 15 Sep 2023
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06049030
- Acronym / sponsor ID
- HS-10516-101
- Conditions
- Renal Cell Carcinoma
- Keywords
- Advanced Clear Cell Renal Cell Carcinoma, Kidney Cancer, Renal Cancer, Recurrent Renal Cell Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Sep 2023 (estimated)
- Primary completion
- 25 Sep 2024 (estimated)
- Study completion
- 25 Sep 2025 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase Ia dose escalation | Experimental | Drug: HS-10516Participants will be assigned to pre-specified dose level to identify the MTD/MAD of HS-10516. |
| Phase Ib dose expansion arm | Experimental | Drug: HS-10516Participants will be assigned to the recommended dose level determined in Phase Ia to evaluate the safety, pharmacokinetics and antitumor efficacy of HS-10516 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (16 listed)
- Received or being received treatment as follows:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HS-10516Oral HIF-2α inhibitor | Drug | Phase Ia dose escalation, Phase Ib dose expansion arm |
Primary outcome
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
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.
9 secondary outcomes
The Number of Participants with Adverse Events
Time frame: Approximately 2 years
Observed maximum plasma concentration (Cmax) of HS-10516
Time frame: Approximately 2 months
Time to reach maximum plasma concentration (Tmax) of HS-10516
Time frame: 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
ORR by investigators
Time frame: Approximately 1 year
Disease Control Rate (DCR)
Time frame: Approximately 1 year
Duration of Response (DoR)
Time frame: Approximately 1 year
Progression Free Survival (PFS)
Time frame: Approximately 2 years
Overall Survival (OS)
Time frame: Approximately 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jun Guo, M.D. principal investigator
Peking University Cancer Hospital & Institute
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HS-10516 in people with Renal Cell Carcinoma, run by Jiangsu Hansoh Pharmaceutical Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yun Chen (+86 18652105250, cheny22@hspharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase Ia: MTD/MAD of HS-10516 (time frame: Approximately 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2023.