NSCLCPhase 1NCT07685041
An Open-label, Fixed-sequence Phase I Clinical Trial to Evaluate the Effect of HS-10504 on the Pharmacokinetics of Midazolam in Patients With Non-small Cell Lung Cancer
A Phase 1 study testing HS-10504； midazolam in people with NSCLC, run by Jiangsu Hansoh Pharmaceutical Co., Ltd..
Trial summary
This is an open-label, fixed-sequence Phase I clinical trial to evaluate the effect of HS-10504 on the pharmacokinetics of midazolam (CYP3A4 substrate) in patients with EGFR mutation-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have experienced disease progression during or after… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC
- What is being tested?
- HS-10504； midazolam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 27 Jun 2026to 20 Jul 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed locally advanced or metastatic NSCLC
- Disease progression or intolerance to prior third-generation EGFR TKI therapy in patients with mNSCLC
- Confirmed EGFR mutation positivity in participants before enrollment.
- At least one target lesion according to RECIST 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 with no deterioration in the 2 weeks prior to the first dose
- Minimum life expectancy greater than 12 weeks
- Female participants of childbearing potential must agree to use appropriate contraception (refer to section 12.5) from the time of signing informed consent until 6 months after the last dose, and should not breastfeed; male participants must agree to use barrier contraception (i.e., condoms) from the time of signing informed consent until 6 months after the last dose
- Willing to participate in this clinical trial, understand the study procedures, and be able to provide written informed consent.
Who cannot join
- Has received or is currently receiving the following treatments:
- Prior or current treatment with a fourth-generation EGFR tyrosine kinase inhibitor.
- Use of strong/moderate inhibitors or strong/moderate inducers of CYP3A4, CYP3A5, CYP2C8, and/or CYP2D6, or narrow therapeutic index drugs that are sensitive substrates of CYP3A4, CYP3A5, P-gp, and BCRP within 14 days or 5 half-lives (whichever is longer) prior to the first dose of investigational product; or need to continue these medications during the study period.
- Use of drugs that affect gastric acid secretion or intragastric pH within 7 days prior to the first dose of investigational product.
- Currently receiving treatment with drugs known to prolong the QT interval or that may cause torsade de pointes; or need to continue these medications during the study period
- Presence of toxicities from prior anti-tumor therapy that have not resolved to < Grade 2 according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Show all 31Show fewer
- History of other primary malignancies.
- Inadequate bone marrow reserve or hepatic/renal organ function.
- Meets any of the following cardiac criteria:
- Mean Fridericia-corrected QT interval (QTcF) > 470 msec on resting electrocardiogram (ECG);
- Resting ECG shows any clinically significant rhythm, conduction, or ECG morphological abnormality deemed important by the investigator (e.g., complete left bundle branch block, third-degree atrioventricular block, second-degree atrioventricular block, and PR interval > 250 msec, etc.);
- Presence of any factors that increase the risk of QT prolongation or arrhythmic events, such as heart failure, refractory hypokalemia, congenital long QT syndrome, family history of long QT syndrome, unexplained sudden death in a first-degree relative under 40 years of age, or any concomitant medication that prolongs the QT interval;
- Left ventricular ejection fraction (LVEF) < 50%.
- Severe, uncontrolled, or active cardiovascular disease.
- Severe or poorly controlled diabetes mellitus.
- Severe or poorly controlled hypertension.
- Clinically significant bleeding symptoms or obvious bleeding tendency within 1 month prior to the first dose.
- Severe arterial thrombotic event within 3 months prior to the first dose.
- Severe infection within 4 weeks prior to the first dose.
- Continuous corticosteroid therapy for more than 30 days within 30 days prior to the first dose, or need for long-term corticosteroid therapy, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation
- Known active infectious disease.
- Clinically severe gastrointestinal abnormalities that may affect drug intake, transport, or absorption.
- Hepatic encephalopathy, hepatorenal syndrome, or ≥C (incomplete in original).
- Other moderate to severe pulmonary diseases that seriously impair respiratory function and may interfere with the detection or management of drug-related pulmonary toxicity.
- Previous history of severe neurological or psychiatric disorders.
- Female participants who are pregnant, breastfeeding, or planning to become pregnant during the study period.
- History of severe allergies, or hypersensitivity to any component of HS-10504 tablets or midazolam oral solution, or history of hypersensitivity to drugs with a similar chemical structure or of the same class as HS-10504.
- History of ventilation difficulty or severe airway obstruction.
- Any severe or uncontrolled ocular condition that, in the physician's judgment, may increase the patient's risk; or ocular abnormalities requiring surgery or expected to require surgical treatment during the study period.
- Participants who, in the investigator's judgment, may have poor compliance with study procedures and requirements.
- In the investigator's judgment, presence of any life-threatening complication.
About this study
This is an open-label, fixed-sequence Phase I clinical trial to evaluate the effect of HS-10504 on the pharmacokinetics of midazolam (CYP3A4 substrate) in patients with EGFR mutation-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have experienced disease progression during or after treatment with EGFR-TKIs.
Read the detailed description
This study consists of two stages: Stage 1 (DDI evaluation period, C0D1 to C2D21) and Stage 2 (drug donation period, from C3D1 onward). Each cycle contains 21 days, except for Cycle 0.
Stage 1 (DDI evaluation period, C0D1 to C2D21): Enrolled participants receive a single oral dose of midazolam oral solution 1 mg (2 mg/mL, 0.5 mL) on C0D1 and C2D20, respectively; and receive HS-10504 tablets 400 mg (100 mg/tablet, 4 tablets) once daily from C1D1 to C2D21.
Stage 2 (drug donation period, from C3D1 onward): After completing Stage 1, participants may decide, based on the investigator's judgment and their own willingness, whether to enter Stage 2 (the extended drug donation period, which is optional and not mandatory). This stage continues until the participant voluntarily requests discontinuation, is lost to follow-up, experiences disease progression, develops intolerable toxicity, is judged by the investigator to no longer derive benefit from the treatment, or the drug has been approved for marketing, whichever occurs first.
- Conditions
- NSCLC
- Being tested
- HS-10504； midazolam
- Keywords
- Phase I, Drug interaction, HS-10504, NSCLC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-10504； midazolamDrug
HS-10504：Participants receive HS-10504 tablets 400 mg (100 mg/tablet, 4 tablets) once daily Midazolam：Participants receive a single oral dose of midazolam oral solution 1 mg (2 mg/mL, 0.5 mL) on C0D1 and C2D20, respectively。
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Drug-drug interaction Arm Receives: Drug: HS-10504； midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of PK parameters of Midazolam: Cmax
To evaluate the Cmax of Midazolam administered alone and in combination with HS-10504
Measured: 24 hours after administration of Midazolam
Evaluation of PK parameters of Midazolam: AUC0-t
To evaluate the AUC0-t of Midazolam administered alone and in combination with HS-10504
Measured: 24 hours after administration of Midazolam
Evaluation of PK parameters of Midazolam: AUC0-∞
To evaluate the AUC0-∞ of Midazolam administered alone and in combination with HS-10504
Measured: 24 hours after administration of Midazolam
Secondary outcomes (29)
Evaluation of PK parameters of Midazolam: Tmax
To evaluate the Tmax of Midazolam administered alone and in combination with HS-10504
Measured: 24 hours after administration of Midazolam
Evaluation of PK parameters of Midazolam: t1/2z
To evaluate the t1/2z of Midazolam administered alone and in combination with HS-10504
Measured: 24 hours after administration of Midazolam
Evaluation of PK parameters of Midazolam: λz
To evaluate the λz of Midazolam administered alone and in combination with HS-10504
Measured: 24 hours after administration of Midazolam
Evaluation of PK parameters of Midazolam: CLz/F
To evaluate the CLz/F of Midazolam administered alone and in combination with HS-10504
Measured: 24 hours after administration of Midazolam
Evaluation of PK parameters of Midazolam: Vz/F.
To evaluate the Vz/F of Midazolam administered alone and in combination with HS-10504
Measured: 24 hours after administration of Midazolam
Evaluation of PK parameters of 1-OH Midazolam: Cmax
To evaluate the Cmax of 1-OH Midazolam administered alone and in combination with HS-10504
Measured: 24 hours after administration of Midazolam
Evaluation of PK parameters of 1-OH Midazolam: AUC0-t
To evaluate the AUC0-t of 1-OH Midazolam administered alone and in combination with HS-10504
Measured: 24 hours after administration of Midazolam
Evaluation of PK parameters of 1-OH Midazolam: AUC0-∞
To evaluate the AUC0-∞ of 1-OH Midazolam administered alone and in combination with HS-10504
Measured: 24 hours after administration of Midazolam
Evaluation of PK parameters of 1-OH Midazolam: Tmax
To evaluate the Tmax of 1-OH Midazolam administered alone and in combination with HS-10504
Measured: 24 hours after administration of Midazolam
Evaluation of PK parameters of 1-OH Midazolam: t1/2z.
To evaluate the t1/2z of 1-OH Midazolam administered alone and in combination with HS-10504
Measured: 24 hours after administration of Midazolam
Evaluation of PK parameters of HS-10504 and metabolite M6-2: Cmin
To evaluate the Cmin of HS-10504 and metabolite M6-2
Measured: 24 hours after administration of HS-10504
Evaluation of PK parameters of HS-10504 and metabolite M6-2: Cmax
To evaluate the Cmax of HS-10504 and metabolite M6-2
Measured: 24 hours after administration of HS-10504
Evaluation of PK parameters of HS-10504 and metabolite M6-2: AUC0-24 h
To evaluate the AUC0-24 h of HS-10504 and metabolite M6-2
Measured: 24 hours after administration of HS-10504
Evaluation of PK parameters of HS-10504 and metabolite M6-2: Tmax.
To evaluate the Tmax of HS-10504 and metabolite M6-2
Measured: 24 hours after administration of HS-10504
Adverse events
To evaluate the adverse events (AEs) of Midazolam administered alone and in combination with HS-10504.
Measured: through study completion, an average of 43 days
blood pressure
To evaluate the blood pressure of Midazolam administered alone and in combination with HS-10504.
Measured: through study completion, an average of 43 days
Pulse
To evaluate the Puls of Midazolam administered alone and in combination with HS-10504.
Measured: through study completion, an average of 43 days
body temperature
To evaluate the body temperature of Midazolam administered alone and in combination with HS-10504.
Measured: through study completion, an average of 43 days
respiratory rate
To evaluate the respiratory rate of Midazolam administered alone and in combination with HS-10504.
Measured: through study completion, an average of 43 days
complete blood count (CBC)
To evaluate the complete blood count (CBC) of Midazolam administered alone and in combination with HS-10504.
Measured: through study completion, an average of 43 days
urinalysis
To evaluate the urinalysis of Midazolam administered alone and in combination with HS-10504.
Measured: through study completion, an average of 43 days
blood chemistry
To evaluate the blood chemistry of Midazolam administered alone and in combination with HS-10504.
Measured: through study completion, an average of 43 days
coagulation tests
To evaluate the coagulation tests of Midazolam administered alone and in combination with HS-10504.
Measured: through study completion, an average of 43 days
12-lead electrocardiogram（heart rate）
To evaluate the 12-lead electrocardiogram（heart rate） of Midazolam administered alone and in combination with HS-10504
Measured: through study completion, an average of 43 days
12-lead electrocardiogram（PR）
To evaluate the 12-lead electrocardiogram（PR） of Midazolam administered alone and in combination with HS-10504
Measured: through study completion, an average of 43 days
12-lead electrocardiogram（RR）
To evaluate the 12-lead electrocardiogram（RR） of Midazolam administered alone and in combination with HS-10504
Measured: through study completion, an average of 43 days
12-lead electrocardiogram（QRS duration）
To evaluate the 12-lead electrocardiogram（QRS duration） of Midazolam administered alone and in combination with HS-10504
Measured: through study completion, an average of 43 days
12-lead electrocardiogram（QTcF）
To evaluate the 12-lead electrocardiogram（QTcF） of Midazolam administered alone and in combination with HS-10504
Measured: through study completion, an average of 43 days
physical examination of Midazolam administered alone and in combination with HS-10504.
To evaluate the abnormal of the physical examination（1) Eyes; 2) Ear, nose, throat; 3) Cardiovascular system; 4) Chest and respiratory system; 5) Abdominal examination; 6) Skin and mucous membranes; 7) Spine and limbs; 8) Musculoskeletal system; 9) Nervous system; 10) Lymph nodes; 11) Genitourinary system; 12) Others.） of Midazolam administered alone and in combination with HS-10504.
Measured: through study completion, an average of 43 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start27 Jun 2026 (estimated)
- Primary completion19 Nov 2026 (estimated)
- Study completion20 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies 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
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07685041
- Sponsor's protocol ID
- HS-10504-113
- Status last verified
- Jun 2026
- First submitted
- 1 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Fixed-sequence Phase I Clinical Trial to Evaluate the Effect of HS-10504 on the Pharmacokinetics of Midazolam in Patients With Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07685041
- Acronym / sponsor ID
- HS-10504-113
- Conditions
- NSCLC
- Keywords
- Phase I, Drug interaction, HS-10504, NSCLC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Jun 2026 (estimated)
- Primary completion
- 19 Nov 2026 (estimated)
- Study completion
- 20 Jul 2027 (estimated)
- First posted
- 6 Jul 2026 (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.
This is an open-label, fixed-sequence Phase I clinical trial to evaluate the effect of HS-10504 on the pharmacokinetics of midazolam (CYP3A4 substrate) in patients with EGFR mutation-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have experienced disease progression during or after treatment with EGFR-TKIs.
Detailed description
This study consists of two stages: Stage 1 (DDI evaluation period, C0D1 to C2D21) and Stage 2 (drug donation period, from C3D1 onward). Each cycle contains 21 days, except for Cycle 0.
Stage 1 (DDI evaluation period, C0D1 to C2D21): Enrolled participants receive a single oral dose of midazolam oral solution 1 mg (2 mg/mL, 0.5 mL) on C0D1 and C2D20, respectively; and receive HS-10504 tablets 400 mg (100 mg/tablet, 4 tablets) once daily from C1D1 to C2D21.
Stage 2 (drug donation period, from C3D1 onward): After completing Stage 1, participants may decide, based on the investigator's judgment and their own willingness, whether to enter Stage 2 (the extended drug donation period, which is optional and not mandatory). This stage continues until the participant voluntarily requests discontinuation, is lost to follow-up, experiences disease progression, develops intolerable toxicity, is judged by the investigator to no longer derive benefit from the treatment, or the drug has been approved for marketing, whichever occurs first.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: HS-10504； midazolamDrug-drug interaction Arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically or cytologically confirmed locally advanced or metastatic NSCLC
- Disease progression or intolerance to prior third-generation EGFR TKI therapy in patients with mNSCLC
- Confirmed EGFR mutation positivity in participants before enrollment.
- At least one target lesion according to RECIST 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 with no deterioration in the 2 weeks prior to the first dose
Key exclusion criteria (31 listed)
- Has received or is currently receiving the following treatments:
- Presence of toxicities from prior anti-tumor therapy that have not resolved to < Grade 2 according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
- History of other primary malignancies.
- Inadequate bone marrow reserve or hepatic/renal organ function.
- Meets any of the following cardiac criteria:
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-10504； midazolamHS-10504：Participants receive HS-10504 tablets 400 mg (100 mg/tablet, 4 tablets) once daily Midazolam：Participants receive a single oral dose of midazolam oral solution 1 mg (2 mg/mL, 0.5 mL) on C0D1 and C2D20, respectively。 | Drug | Experimental group |
Primary outcome
Evaluation of PK parameters of Midazolam: Cmax
Time frame: 24 hours after administration of Midazolam
To evaluate the Cmax of Midazolam administered alone and in combination with HS-10504
Evaluation of PK parameters of Midazolam: AUC0-t
Time frame: 24 hours after administration of Midazolam
To evaluate the AUC0-t of Midazolam administered alone and in combination with HS-10504
Evaluation of PK parameters of Midazolam: AUC0-∞
Time frame: 24 hours after administration of Midazolam
To evaluate the AUC0-∞ of Midazolam administered alone and in combination with HS-10504
29 secondary outcomes
Evaluation of PK parameters of Midazolam: Tmax
Time frame: 24 hours after administration of Midazolam
Evaluation of PK parameters of Midazolam: t1/2z
Time frame: 24 hours after administration of Midazolam
Evaluation of PK parameters of Midazolam: λz
Time frame: 24 hours after administration of Midazolam
Evaluation of PK parameters of Midazolam: CLz/F
Time frame: 24 hours after administration of Midazolam
Evaluation of PK parameters of Midazolam: Vz/F.
Time frame: 24 hours after administration of Midazolam
Evaluation of PK parameters of 1-OH Midazolam: Cmax
Time frame: 24 hours after administration of Midazolam
Evaluation of PK parameters of 1-OH Midazolam: AUC0-t
Time frame: 24 hours after administration of Midazolam
Evaluation of PK parameters of 1-OH Midazolam: AUC0-∞
Time frame: 24 hours after administration of Midazolam
Evaluation of PK parameters of 1-OH Midazolam: Tmax
Time frame: 24 hours after administration of Midazolam
Evaluation of PK parameters of 1-OH Midazolam: t1/2z.
Time frame: 24 hours after administration of Midazolam
Evaluation of PK parameters of HS-10504 and metabolite M6-2: Cmin
Time frame: 24 hours after administration of HS-10504
Evaluation of PK parameters of HS-10504 and metabolite M6-2: Cmax
Time frame: 24 hours after administration of HS-10504
Evaluation of PK parameters of HS-10504 and metabolite M6-2: AUC0-24 h
Time frame: 24 hours after administration of HS-10504
Evaluation of PK parameters of HS-10504 and metabolite M6-2: Tmax.
Time frame: 24 hours after administration of HS-10504
Adverse events
Time frame: through study completion, an average of 43 days
blood pressure
Time frame: through study completion, an average of 43 days
Pulse
Time frame: through study completion, an average of 43 days
body temperature
Time frame: through study completion, an average of 43 days
respiratory rate
Time frame: through study completion, an average of 43 days
complete blood count (CBC)
Time frame: through study completion, an average of 43 days
urinalysis
Time frame: through study completion, an average of 43 days
blood chemistry
Time frame: through study completion, an average of 43 days
coagulation tests
Time frame: through study completion, an average of 43 days
12-lead electrocardiogram（heart rate）
Time frame: through study completion, an average of 43 days
12-lead electrocardiogram（PR）
Time frame: through study completion, an average of 43 days
12-lead electrocardiogram（RR）
Time frame: through study completion, an average of 43 days
12-lead electrocardiogram（QRS duration）
Time frame: through study completion, an average of 43 days
12-lead electrocardiogram（QTcF）
Time frame: through study completion, an average of 43 days
physical examination of Midazolam administered alone and in combination with HS-10504.
Time frame: through study completion, an average of 43 days
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 6 Jul 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HS-10504； midazolam in people with NSCLC, 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 31 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: opening soon, as of the sponsor's last update on 6 Jul 2026. 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?
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of PK parameters of Midazolam: Cmax (time frame: 24 hours after administration of Midazolam). The study lists 3 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 6 Jul 2026.