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

Sponsored by Jiangsu Hansoh Pharmaceutical Co., Ltd.

About this trial

Last updated a year ago

Study ID

HS-10529-101

Status

Not yet recruiting

Type

Interventional

Phase

Phase 1

Placebo

Accepting

18+ Years

All Sexes

Trial Timing

Started a year ago

What is this trial 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.

What are the participation requirements?

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.