Status:
UNKNOWN
Phase 1/2 Study of HS-10376 in Patients With Non-Small Cell Lung Cancer
Lead Sponsor:
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Conditions:
Advanced Non-Small-Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 H...
Detailed 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...
Eligibility Criteria
Inclusion
- 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, tumor tissue samples can be used to test EGFR/HER2 Exon 20 insertion mutation by central laboratory for 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
- Treatment with any of the following:
- Previous or current treatment with EGFR Exon 20 insertion inhibitors, HER2 Exon 20 insertion inhibitors or EGFR/HER2 Exon 20 insertion inhibitors
- Any cytotoxic chemotherapy, anticancer Chinese medicine and targeted small molecule inhibitors within 14 days of the first dose of HS-10376
- Any investigational agents and large molecule antibodies within 28 days of the first dose of HS-10376
- Local radiotherapy for palliation within 2 weeks of the first dose of HS-10376, or patients received more than 30% of the bone marrow irradiation, or large-scale radiotherapy within 4 weeks of the first dose of HS-10376
- Major surgery (including craniotomy, thoracotomy, or laparotomy, etc.) within 4 weeks of the first dose of HS-10376
- 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
Key Trial Info
Start Date :
September 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 7 2025
Estimated Enrollment :
380 Patients enrolled
Trial Details
Trial ID
NCT05435274
Start Date
September 30 2021
End Date
October 7 2025
Last Update
June 28 2022
Active Locations (1)
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1
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China, 300181