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About
HS-10376 is an oral, highly selective, small molecular inhibitor of EGFR/HER2 Exon 20 insertion mutation. This study will evaluate the safety, tolerability, pharmacokinetics and clinical activity of HS-10376 in Chinese advanced Non-Small Cell Lung Cancer (NSCLC) patients.
Full description
This is a phase 1/2, first-in-human, open-label, multicenter study of HS-10376, this study has two parts: phase 1 and phase 2. The phase 1 portion consists of dose escalation and dose expansion, which is aimed to assess the safety and tolerability of HS-10376 in subjects with advanced NSCLC and evaluate the preliminary efficacy of HS-10376. Phase 2 will be conducted to evaluate the efficacy of HS-10376 in subjects with locally advanced or metastatic NSCLC with a EGFR Exon 20 insertion mutation.
Enrollment
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Inclusion criteria
Exclusion criteria
Treatment with any of the following:
Inadequate bone marrow reserve or serious organ dysfunction
Uncontrolled pleural, ascites or pericardial effusion
Untreated, symptomatic or active central nervous system metastases
Severe or poorly controlled hypertension
Immunodeficiency disease and 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-10376 or to drugs with a similar chemical structure or drugs belonging to the same category of HS-10376
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
Primary purpose
Allocation
Interventional model
Masking
380 participants in 1 patient group
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Central trial contact
Dingzhi Huang
Data sourced from clinicaltrials.gov
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