Status:
RECRUITING
Phase 1/2 Study of HS-10370 in Patients with Advanced Solid Tumors
Lead Sponsor:
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Conditions:
Advanced Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
HS-10370 is an oral, highly selective, small molecular inhibitor of KRAS G12C. This study will evaluate the safety, tolerability, pharmacokinetics and clinical activity of HS-10370 in Chinese advanced...
Detailed Description
This is a phase 1/2, first-in-human, open-label, multicenter study of HS-10370, 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
- Subjects must meet all of the following inclusion criteria to be eligible for participation in this study:
- Men or women greater than or equal to 18 years
- Locally advanced or metastatic cancer patients confirmed by histology or cytology, for which standard treatment is invalid, unavailable or intolerable
- Pathological, tumor tissue samples can be used to test KRAS G12C mutation by central laboratory for Phase 1b 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 KRAS G12C inhibitors
- Any cytotoxic chemotherapy, anticancer Chinese medicine and targeted small molecule inhibitors within 14 days of the first dose of HS-10370
- Any investigational agents and large molecule antibodies within 28 days of the first dose of HS-10370
- Local radiotherapy for palliation within 2 weeks of the first dose of HS-10370, or patients received more than 30% of the bone marrow irradiation, or large-scale radiotherapy within 4 weeks of the first dose of HS-10370
- Major surgery (including craniotomy, thoracotomy, or laparotomy, etc.) within 4 weeks of the first dose of HS-10370
- 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-10370 or to drugs with a similar chemical structure or drugs belonging to the same category of HS-10370
- 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 :
June 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2026
Estimated Enrollment :
176 Patients enrolled
Trial Details
Trial ID
NCT05367778
Start Date
June 3 2022
End Date
April 30 2026
Last Update
September 19 2024
Active Locations (1)
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1
Union Hospital Tong Ji Medical College, HuaZhong University of Science and Technology
Wuhan, Hubei, China, 430000