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

Hansoh Pharma

Status and phase

Not yet enrolling

Phase 1

Conditions

Advanced Solid Tumors

Treatments

Drug: HS-10529

Study type

Interventional

Funder types

Industry

Identifiers

NCT06963398

HS-10529-101

Details and patient eligibility

About

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.

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

Enrollment

520 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.