- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05435248
Hase 1/2 Study of HS-10375 in Patients With Advanced or Metastatic Non-Small-Cell Lung Cancer(NSCLC)
A Phase 1/2, Open-label, Multicenter Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of HS-10375 Monotherapy in Patients With Advanced or Metastatic Non-Small-Cell Lung Cancer(NSCLC)
Study Overview
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Li Zhang, Master
- Phone Number: 13902282893
- Email: zhangli@sysucc.org.cn
Study Locations
-
-
Guangdong
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Guangzhou, Guangdong, China, 510060
- Recruiting
- Sun Yat-sen University Cancer Center
-
Contact:
- Li Zhang
- Phone Number: 13902282893
- Email: zhangli@sysucc.org.cn
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Men or women greater than or equal to 18 years.
- Locally advanced or metastatic NSCLC patients confirmed by histology or cytology, for which standard treatment is invalid, unavailable or intolerable .
- Pathological, NSCLC tissue samples can be used to test EGFR C797S mutation by central laboratory for Phase 1b and Phase II subjects.
- At least one measurable lesion in accordance with RECIST 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status: 0~1.
- Estimated life expectancy >12 weeks.
- Reproductive-age women agree to use adequate contraception and cannot breastfeed while participating in this study and for a period of 6 months after the last dose. Likewise, men also consent to use adequate contraceptive method within the same time limit.
- Females must have the evidence of non-childbearing potential.
- Signed and dated Informed Consent Form.
Exclusion Criteria:
Treatment with any of the following:
- Previous or current treatment with EGFR C797S inhibitors.
- Any cytotoxic chemotherapy, anticancer Chinese medicine and targeted small molecule inhibitors within 14 days of the first dose of HS-10375.
- Any investigational agents and large molecule antibodies within 28 days of the first dose of HS-10375.
- Local radiotherapy for palliation within 2 weeks of the first dose of HS-10375, or patients received more than 30% of the bone marrow irradiation, or large-scale radiotherapy within 4 weeks of the first dose of HS-10375.
- Major surgery (including craniotomy, thoracotomy, or laparotomy, etc.) within 4 weeks of the first dose of HS-10375.
- Inadequate bone marrow reserve or serious organ dysfunction.
- Uncontrolled pleural, ascites or pericardial effusion.
- Known and untreated, or active central nervous system metastases.
- Active autoimmune diseases or active infectious disease.
- Refractory nausea, vomiting, or chronic gastrointestinal diseases, or inability to swallow oral medications.
- History of hypersensitivity to any active or inactive ingredient of HS-10375 or to drugs with a similar chemical structure or drugs belonging to the same category of HS-10375.
- The subject who is unlikely to comply with study procedures, restrictions, or requirements judged by the investigator.
- The subject whose safety cannot be ensured or study assessments would be interfered judged by the investigator.
- Pregnant women, breastfeeding women or woman who has a child-bearing plan during the study.
- History of neuropathy or mental disorders, including epilepsy and dementia.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HS-10375
Experimental: HS-10375(Phase 1a:Dose Escalation) Subjects with advanced or metastatic NSCLC will be enrolled in dose escalation cohorts. Dose escalation of HS-10375 will be done to determine maximum tolerated dose. Experimental: HS-10375(Phase 1b:Dose Expansion) Depending on data obtained from the dose escalation part, dose expansion may proceed with multiple cohorts in subjects with advanced or metastatic NSCLC having a EGFR C797S mutation. Experimental: HS-10375(Phase 2) Subjects with locally advanced or metastatic EGFR C797S mutant NSCLC will be enrolled in phase 2 part to evaluate the efficacy and sufficient safety of HS-10375 as monotherapy. |
HS-10375 will be administered orally once daily in a continuous regimen
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To determine the maximum tolerated dose (MTD)-Part Ia
Time Frame: From the single dose to the last dose of the first cycle defined as 21 days of multiple dosing (28 days)
|
Number of participants with dose limiting toxicity
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From the single dose to the last dose of the first cycle defined as 21 days of multiple dosing (28 days)
|
To evaluate clinical activity/efficacy of HS-10375 by assessment of objective response rate-Part Ib/II
Time Frame: Time Frame: up to 24 months
|
Objective response rate (ORR) assessed by Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1)
|
Time Frame: up to 24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with treatment related adverse events
Time Frame: From baseline until 28 days after the last dose
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Number of participants with treatment related adverse events
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From baseline until 28 days after the last dose
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Observed maximum plasma concentration (Cmax) after single dose of HS-10375
Time Frame: From pre-dose to 120 hours after single dose on Day 1
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In the study of single-dose, Cmax will be obtained following administration of a single oral dose of HS-10375
|
From pre-dose to 120 hours after single dose on Day 1
|
Time to reach maximum plasma concentration (Tmax) after single dose of HS-10375
Time Frame: From pre-dose to 120 hours after single dose on Day 1
|
In the study of single-dose, Tmax will be obtained following administration of a single oral dose of HS-10375
|
From pre-dose to 120 hours after single dose on Day 1
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Apparent terminal half-life (T1/2) after single dose of HS-10375
Time Frame: From pre-dose to 120 hours after single dose on Day 1
|
Apparent terminal half-life is the time measured for the concentration to decrease by one half.
Terminal half-life calculated by natural log 2 divided by λz
|
From pre-dose to 120 hours after single dose on Day 1
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Duration of response (DOR)
Time Frame: 24 months
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DOR assessed by RECIST 1.1 criteria
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24 months
|
Disease Control Rate (DCR)
Time Frame: 24 months
|
DCR assessed by RECIST 1.1 criteria
|
24 months
|
Progression-free survival (PFS)
Time Frame: 24 months
|
PFS assessed by RECIST 1.1 criteria
|
24 months
|
Overall survival (OS)
Time Frame: 24 months
|
24 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HS-10375-101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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