Actively Recruiting
Phase 1/2 Study of HS-10370 in Patients with Advanced Solid Tumors
Led by Jiangsu Hansoh Pharmaceutical Co., Ltd. · Updated on 2024-09-19
176
Participants Needed
1
Research Sites
203 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 solid tumor patients.
CONDITIONS
Official Title
Phase 1/2 Study of HS-10370 in Patients with Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men or women aged 18 years or older
- Diagnosis of locally advanced or metastatic cancer confirmed by histology or cytology
- Standard treatments are ineffective, unavailable, or intolerable
- Tumor tissue available for KRAS G12C mutation testing (for Phase 1b participants)
- At least one measurable tumor 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 age agree to use effective contraception and not breastfeed during the study and for 6 months after last dose
- Women must have evidence of non-childbearing potential
- Signed informed consent form
You will not qualify if you...
- Previous or current treatment with KRAS G12C inhibitors
- Any chemotherapy, anticancer Chinese medicine, or targeted small molecule inhibitors within 14 days before first dose
- Use of investigational agents or large molecule antibodies within 28 days before first dose
- Local radiotherapy for palliation within 2 weeks before first dose, or more than 30% bone marrow irradiation, or large-scale radiotherapy within 4 weeks before first dose
- Major surgery (e.g., craniotomy, thoracotomy, laparotomy) within 4 weeks before first dose
- 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
- Severe nausea, vomiting, chronic gastrointestinal disease, or inability to take oral medications
- History of hypersensitivity to HS-10370 or similar drugs
- Unlikely to comply with study procedures or restrictions
- Safety concerns or interference with study assessments as judged by the investigator
- Pregnant or breastfeeding women, or women planning pregnancy during the study
- History of neuropathy or mental disorders including epilepsy and dementia
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Union Hospital Tong Ji Medical College, HuaZhong University of Science and Technology
Wuhan, Hubei, China, 430000
Actively Recruiting
Research Team
X
Xiaorong Dong, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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