Status:
NOT_YET_RECRUITING
A Study of HS-10529 in KRAS G12D Patients With Advanced Solid Tumors
Lead Sponsor:
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
HS-10529 is an oral, highly selective, small molecular inhibitor of KRAS G12D. This study will evaluate the safety, tolerability, pharmacokinetics and clinical activity of HS-10529 in KRAS G12D patien...
Detailed Description
This is a phase 1, first-in-human, study of HS-10529, consisting of dose escalation and dose expansion, which is aimed to assess the safety and tolerability of HS-10529 in KRAS G12D patients with adva...
Eligibility Criteria
Inclusion
- At least age of 18 years at screening.
- Patients of advanced solid tumor，who have progressed on or intolerant to standard therapy.
- With measurable lesion according to RECIST 1.1.
- Agree to provide fresh or archival tumor tissue.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0\~1.
Exclusion
- Previous or current treatment with KRAS G12D inhibitors.
- Uncontrolled pleural, ascites or pericardial effusion.
- Known and untreated, or active central nervous system metastases.
- History of other primary malignant tumors.
- Serious, uncontrolled, or active comorbidities.
- Refractory nausea, vomiting, or chronic gastrointestinal diseases, or inability to swallow oral medications.
Key Trial Info
Start Date :
May 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2029
Estimated Enrollment :
520 Patients enrolled
Trial Details
Trial ID
NCT06963398
Start Date
May 15 2025
End Date
August 30 2029
Last Update
May 9 2025
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