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NCT06963398

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

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Aún no reclutando Fase 1

Descripción

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.

Criterios de Elegibilidad

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.

Información del Ensayo

NCT06963398
Aún no reclutando
Fase 1
520 participantes
May 2025
Abr 2029