Actively Recruiting
Phase 1/2 Study of HS-10375 in Patients with Advanced or Metastatic Non-Small-Cell Lung Cancer(NSCLC)
Led by Jiangsu Hansoh Pharmaceutical Co., Ltd. · Updated on 2024-11-04
354
Participants Needed
1
Research Sites
212 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
HS-10375 is an oral, highly selective, small molecular inhibitor of EGFR C797S. This study will evaluate the safety, tolerability, pharmacokinetics and clinical activity of HS-10375 in Chinese advanced or metastatic NSCLC.
CONDITIONS
Official Title
Phase 1/2 Study of HS-10375 in Patients with Advanced or Metastatic Non-Small-Cell Lung Cancer(NSCLC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men or women aged 18 years or older
- Confirmed locally advanced or metastatic NSCLC by histology or cytology
- Standard treatment is ineffective, unavailable, or intolerable
- NSCLC tissue available for EGFR C797S mutation testing (for Phase 1b and Phase 2 subjects)
- At least one measurable lesion according to RECIST 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Estimated life expectancy greater than 12 weeks
- Women of reproductive potential agree to use contraception and not breastfeed during and for 6 months post-treatment
- Men agree to use adequate contraception during and for 6 months post-treatment
- Females must have proof of non-childbearing potential
- Signed informed consent form
You will not qualify if you...
- Previous or current treatment with EGFR C797S inhibitors
- Cytotoxic chemotherapy, anticancer Chinese medicine, or targeted small molecule inhibitors within 14 days before starting HS-10375
- Investigational agents or large molecule antibodies within 28 days before starting HS-10375
- Local radiotherapy for palliation within 2 weeks before HS-10375 or large-scale radiotherapy within 4 weeks
- Major surgery within 4 weeks before starting HS-10375
- Inadequate bone marrow reserve or serious organ dysfunction
- Uncontrolled pleural, ascites, or pericardial effusion
- Known untreated or active central nervous system metastases
- Active autoimmune or infectious diseases
- Refractory nausea, vomiting, chronic gastrointestinal diseases, or inability to swallow oral medications
- History of hypersensitivity to HS-10375 or similar drugs
- Unlikely to comply with study procedures or restrictions
- Safety concerns or interference with study assessments as judged by investigator
- Pregnant, breastfeeding, or planning pregnancy during the study
- History of neuropathy or mental disorders including epilepsy and dementia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
L
Li Zhang, Master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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