Status:
RECRUITING
Phase 1/2 Study of HS-10375 in Patients with Advanced or Metastatic Non-Small-Cell Lung Cancer(NSCLC)
Lead Sponsor:
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Conditions:
Advanced or Metastatic NSCLC
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 advance...
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, 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
- 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.
Key Trial Info
Start Date :
March 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
354 Patients enrolled
Trial Details
Trial ID
NCT05435248
Start Date
March 2 2022
End Date
March 31 2026
Last Update
November 4 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060