Advanced Solid TumorPhase 1NCT05911464
A Phase I Study of HS-10386 in Participants With Advanced Solid Tumors
A Phase 1 study testing HS-10386 in people with Advanced Solid Tumor, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, and preliminary anti-tumor activity of HS-10386 in participants with advanced solid tumors who have failed prior treatments. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- HS-10386
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 1 siteChina
- Study dates
- 2 Mar 2023to 31 Oct 2027
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, 18-75 years old.
- Histologically or cytologically documented, incurable or metastatic solid tumors for which standard treatment either does not exist or has proven ineffective or unavailable or intolerable.
- At least one measurable lesion per RECIST v1.1.
- Willingness to provide fresh or archival tumor biopsy sample.
- An Eastern Cooperative Oncology Group (ECOG) performance status equal to 0-1 with no deterioration over the previous 2 weeks and a minimum life expectancy of 12 weeks.
- Willingness to use adequate contraceptive measures throughout the study.
- Ability to comprehend and willingness to sign a written ICF for the study.
Who cannot join
- Treatment with any of the following:
- Previous or current treatment with systemic immunotherapy.
- Treatment with anticancer medications or investigational drugs within protocol-defined intervals prior to the first scheduled dose of HS-10386.
- Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 except for alopecia.
- Known additional malignancy.
- History or risk of autoimmune disease.
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- Known primary CNS malignancy or symptomatic CNS metastases. Patients with asymptomatic CNS metastases may be enrolled after consultation.
- Inadequate bone marrow reserve or organ function.
- Clinically significant cardiac disease.
- Any evidence of severe or uncontrolled systemic diseases
- Severe infections within 4 weeks prior to the first scheduled dose or symptoms of infection within 2 weeks prior to prior to the first scheduled dose.
- History of organ transplantation or any medical condition requiring the use of systemic immunosuppressive medications.
- Active HBV or HCV infection that requires treatment.
- Known history of HIV.
- Women who are breastfeeding or have a positive urine or serum pregnancy test at the Screening Visit.
- Administration of a live, attenuated vaccine within 4 weeks prior to the first scheduled dose or anticipation that such a live attenuated vaccine will be required during the study.
- History of severe anaphylaxis or allergic to any of the components of HS-10386.
- Any disease or condition that, in the opinion of the investigator, would compromise the safety of the patient or interfere with study assessments.
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
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
Shun Lu, Dr., Shun_lu@hotmail.com
About this study
Official title: A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HS-10386 in Participants With Advanced Solid Tumors
The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, and preliminary anti-tumor activity of HS-10386 in participants with advanced solid tumors who have failed prior treatments.
Read the detailed description
This is a phase I open label, multicenter clinical study to evaluate the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of HS-10386 in subjects with advanced solid tumors.
- Conditions
- Advanced Solid Tumor
- Being tested
- HS-10386
- Keywords
- Advanced Solid Tumors, Immuno-Oncology Therapy, Immunotherapy, Immune Checkpoint Inhibitor, PD-1, PD-L1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-10386Drug
Starting dose 10 mg, administered once daily. If tolerated, subsequent cohorts will test increasing doses of HS-10386, until a maximum tolerated dose (MTD) or maximum applicable dose (MAD) is defined
| Study group | Role | What they receive |
|---|---|---|
| HS-10386 | Experimental | Participants will receive HS-10386 once daily. The duration of each treatment cycle is 21 days. Receives: Drug: HS-10386 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) or Maximum Applicable Dose (MAD) (Dose Escalation Phase)
MTD is defined as the dose level immediately below that at which 2 or more patients exhibit dose limiting toxicity. MAD is defined as the maximum administered dose, when MTD is not reached.
Measured: Up to 21 days from the first dose
Objective Response Rate (ORR) defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) (Dose Expansion Phase)
ORR is defined as the percentage of patients who have at least 1 response of CR or PR prior to any evidence of progression.
Measured: Every 6 weeks for the duration of study participation; estimated to be 12 months.
Secondary outcomes (13)
Incidence and Severity of Adverse Events (AEs)
The number and percentage of patients that experience an AE. The severity of AEs are assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
Measured: From Informed consent until the end of the follow-up period which is defined as 28 days (+7 days) after study treatment is discontinued.
Cmax of HS-10386
Cmax is defined as the maximum observed plasma or serum concentration.
Measured: Approximately 1 month.
Tmax of HS-10386
Tmax is defined as the time to maximum concentration.
Measured: Approximately 1 month.
λz of HS-10386
λz is defined as the apparent terminal-phase disposition rate constant.
Measured: Approximately 1 month.
t1/2 of HS-10386
t1/2 is defined as the apparent terminal-phase disposition half-life.
Measured: Approximately 1 month.
AUC0-t of HS-10386
AUC0-t is defined as the area under the plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t.
Measured: Approximately 1 month
CL/F of HS-10386
CL/F is defined as the apparent oral dose clearance.
Measured: Approximately 1 month.
ORR defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) (Dose Escalation Phase)
ORR is defined as the percentage of patients who have at least 1 response of CR or PR prior to any evidence of progression.
Measured: Every 6 weeks for the duration of study participation; estimated to be 12 months.
Disease Control Rate (DCR)
The DCR is defined as the percentage of patients with a best overall response of CR, PR, or SD.
Measured: Every 6 weeks for the duration of study participation; estimated to be 12 months.
Duration of Response (DoR)
DoR is defined as the time from the date of first documented response until the date of documented progression or death in the absence of disease progression.
Measured: Every 6 weeks for the duration of study participation; estimated to be 12 months.
Progression-Free Survival (PFS)
PFS was defined as the time from random assignment (dose expansion stage) or first dose (dose escalation stage) to PD or death from any cause.
Measured: Every 6 weeks for the duration of study participation; estimated to be 12 months.
Overall Survival (OS) (Dose Expansion Phase)
OS is defined as the time from randomization to death due to any cause.
Measured: From the time of randomization to death due to any cause, approximately 3 years.
The correlation between PD-L1 expression and efficacy of HS-10386
The study will collect tumor tissue samples during screening period and after the treatment. Stratified analysis of the efficacy endpoint of HS-10386 (such as object response, DoR, PFS, etc.) by PD-L1 expression level will be performed to assess the correlation between PD-L1 expression as biomarker and study dose and effeicacy of HS-10386.
Measured: Approximately 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start2 Mar 2023
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 248 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shun Lu, Dr., Principal investigator, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05911464
- Sponsor's protocol ID
- HS-10386-101
- Status last verified
- Jun 2023
- First submitted
- 8 Jun 2023
- Last updated
- 22 Jun 2023
- 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 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HS-10386 in Participants With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05911464
- Acronym / sponsor ID
- HS-10386-101
- Conditions
- Advanced Solid Tumor
- Keywords
- Advanced Solid Tumors, Immuno-Oncology Therapy, Immunotherapy, Immune Checkpoint Inhibitor, PD-1, PD-L1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 248 participants (estimated)
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Mar 2023 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 22 Jun 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 purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, and preliminary anti-tumor activity of HS-10386 in participants with advanced solid tumors who have failed prior treatments.
Detailed description
This is a phase I open label, multicenter clinical study to evaluate the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of HS-10386 in subjects with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HS-10386 | Experimental | Drug: HS-10386Participants will receive HS-10386 once daily. The duration of each treatment cycle is 21 days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female, 18-75 years old.
- Histologically or cytologically documented, incurable or metastatic solid tumors for which standard treatment either does not exist or has proven ineffective or unavailable or intolerable.
- At least one measurable lesion per RECIST v1.1.
- Willingness to provide fresh or archival tumor biopsy sample.
- An Eastern Cooperative Oncology Group (ECOG) performance status equal to 0-1 with no deterioration over the previous 2 weeks and a minimum life expectancy of 12 weeks.
Key exclusion criteria (18 listed)
- Treatment with any of the following:
- Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 except for alopecia.
- Known additional malignancy.
- History or risk of autoimmune disease.
- Known primary CNS malignancy or symptomatic CNS metastases. Patients with asymptomatic CNS metastases may be enrolled after consultation.
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-10386Starting dose 10 mg, administered once daily. If tolerated, subsequent cohorts will test increasing doses of HS-10386, until a maximum tolerated dose (MTD) or maximum applicable dose (MAD) is defined | Drug | HS-10386 |
Primary outcome
Maximum Tolerated Dose (MTD) or Maximum Applicable Dose (MAD) (Dose Escalation Phase)
Time frame: Up to 21 days from the first dose
MTD is defined as the dose level immediately below that at which 2 or more patients exhibit dose limiting toxicity. MAD is defined as the maximum administered dose, when MTD is not reached.
Objective Response Rate (ORR) defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) (Dose Expansion Phase)
Time frame: Every 6 weeks for the duration of study participation; estimated to be 12 months.
ORR is defined as the percentage of patients who have at least 1 response of CR or PR prior to any evidence of progression.
13 secondary outcomes
Incidence and Severity of Adverse Events (AEs)
Time frame: From Informed consent until the end of the follow-up period which is defined as 28 days (+7 days) after study treatment is discontinued.
Cmax of HS-10386
Time frame: Approximately 1 month.
Tmax of HS-10386
Time frame: Approximately 1 month.
λz of HS-10386
Time frame: Approximately 1 month.
t1/2 of HS-10386
Time frame: Approximately 1 month.
AUC0-t of HS-10386
Time frame: Approximately 1 month
CL/F of HS-10386
Time frame: Approximately 1 month.
ORR defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) (Dose Escalation Phase)
Time frame: Every 6 weeks for the duration of study participation; estimated to be 12 months.
Disease Control Rate (DCR)
Time frame: Every 6 weeks for the duration of study participation; estimated to be 12 months.
Duration of Response (DoR)
Time frame: Every 6 weeks for the duration of study participation; estimated to be 12 months.
Progression-Free Survival (PFS)
Time frame: Every 6 weeks for the duration of study participation; estimated to be 12 months.
Overall Survival (OS) (Dose Expansion Phase)
Time frame: From the time of randomization to death due to any cause, approximately 3 years.
The correlation between PD-L1 expression and efficacy of HS-10386
Time frame: Approximately 3 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 22 Jun 2023.
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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.
Shun Lu, Dr. principal investigator
Shanghai Chest 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 HS-10386 in people with Advanced Solid Tumor, 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 18 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 22 Jun 2023. 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 Xingxing Liu (+86 18652105536, liuxx2@hspharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) or Maximum Applicable Dose (MAD) (Dose Escalation Phase) (time frame: Up to 21 days from the first dose). 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 22 Jun 2023.