Von Hippel Lindau-Deficient Clear Cell Renal Cell CarcinomaPhase 1NCT06553339
A Study of HS-10516 in Patients With VHL Syndrome Associated Tumors
A Phase 1 study testing Oral HS-10516 in people with Von Hippel Lindau-Deficient Clear Cell Renal Cell Carcinoma, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.
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 patients with VHL Syndrome Associated Tumors. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Von Hippel Lindau-Deficient Clear Cell Renal Cell Carcinoma
- What is being tested?
- Oral HS-10516
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 19 Jul 2024to 31 Jul 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female from 18 to 80 year-old
- Patients with advanced clear cellrenal cell carcinoma or von Hippel-Lindau Syndrome associated tumors
- 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
- Recieved 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 non-VHL syndrome associated 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 metabolin
- Has any disease or condition would compromise subject safety or interfere with study assessments by investigator's decision
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Kan Gong, PhD, (0086)13910394281, kan.gong@bjmu.edu.cn
About this study
Official title: A Phase I Study of HS-10516 in Patients With VHL Syndrome Associated Tumors，to Investigate Safety, Tolerance, Pharmacokinetic and Efficacy
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.
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 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.
- Being tested
- Oral HS-10516
- Keywords
- Von Hippel Lindau Syndrome, VHL Syndrome, RCC, pNET, CNS hemangioblastoma
- Medical subject headings
- von Hippel-Lindau Disease, Neuroectodermal Tumors, Primitive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral HS-10516Drug
Oral HIF-2α inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Phase Ia dose escalation arm | Experimental | Participants will be assigned to pre-specified dose level to identify the MTD/MAD of HS-10516. Receives: Drug: Oral HS-10516 |
| Phase Ib dose expansion arm 1 | Experimental | Participants with VHL Syndrome associated RCC, whose lesions diameter ≤ 3 cm. Receives: Drug: Oral HS-10516 |
| Phase Ib dose expansion arm 2 | Experimental | Participants with VHL Syndrome associated RCC, who could not be included in arm 1. Receives: Drug: Oral HS-10516 |
| Phase Ib dose expansion arm 3 | Experimental | Participants with VHL Syndrome associated non-RCC tumors. Receives: Drug: Oral 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/IRC per system
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) by investigators/IRC per system
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) by investigators/IRC per system
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) by investigators/IRC per system
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 posted14 Aug 2024
- Study start19 Jul 2024
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Von Hippel Lindau-Deficient Clear Cell 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kan Gong, PhD, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06553339
- Sponsor's protocol ID
- HS-10516-102
- Status last verified
- Aug 2024
- First submitted
- 12 Aug 2024
- Last updated
- 14 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of HS-10516 in Patients With VHL Syndrome Associated Tumors，to Investigate Safety, Tolerance, Pharmacokinetic and Efficacy
- ClinicalTrials.gov ID
- NCT06553339
- Acronym / sponsor ID
- HS-10516-102
- Keywords
- Von Hippel Lindau Syndrome, VHL Syndrome, RCC, pNET, CNS hemangioblastoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Jul 2024 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 14 Aug 2024 (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 patients with VHL Syndrome Associated Tumors.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Phase Ia dose escalation arm | Experimental | Drug: Oral HS-10516Participants will be assigned to pre-specified dose level to identify the MTD/MAD of HS-10516. |
| Phase Ib dose expansion arm 1 | Experimental | Drug: Oral HS-10516Participants with VHL Syndrome associated RCC, whose lesions diameter ≤ 3 cm. |
| Phase Ib dose expansion arm 2 | Experimental | Drug: Oral HS-10516Participants with VHL Syndrome associated RCC, who could not be included in arm 1. |
| Phase Ib dose expansion arm 3 | Experimental | Drug: Oral HS-10516Participants with VHL Syndrome associated non-RCC tumors. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female from 18 to 80 year-old
- Patients with advanced clear cellrenal cell carcinoma or von Hippel-Lindau Syndrome associated tumors
- 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
Key exclusion criteria (16 listed)
- Recieved 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 non-VHL syndrome associated 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 |
|---|---|---|
| Oral HS-10516Oral HIF-2α inhibitor | Drug | Phase Ia dose escalation arm, Phase Ib dose expansion arm 1, Phase Ib dose expansion arm 2, Phase Ib dose expansion arm 3 |
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/IRC per system
Time frame: Approximately 1 year
Disease Control Rate (DCR) by investigators/IRC per system
Time frame: Approximately 1 year
Duration of Response (DoR) by investigators/IRC per system
Time frame: Approximately 1 year
Progression Free Survival (PFS) by investigators/IRC per system
Time frame: Approximately 2 years
Overall Survival (OS)
Time frame: Approximately 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
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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.
Kan Gong, PhD principal investigator
Peking University First Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oral HS-10516 in people with Von Hippel Lindau-Deficient Clear Cell Renal Cell Carcinoma, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.
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 7 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: looking for participants now, as of the sponsor's last update on 14 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kan Gong, PhD (13910394281, kan.gong@bjmu.edu.cn), 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 14 Aug 2024.