A Study of HS-10529 in KRAS G12D Patients With Advanced Solid Tumors

A Phase 1 Study, Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of HS-10529 Monotherapy in KRAS G12D Patients With Advanced Solid Tumors

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 patients with advanced solid tumors.

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 advanced solid tumors and evaluate the preliminary efficacy of HS-10529.

Inclusion Criteria:

• 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 Criteria:

• 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.