Clinical Trials Directory

Trials / Not Yet Recruiting

Not Yet RecruitingNCT06963398

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

Status
Not Yet Recruiting
Phase
Phase 1
Study type
Interventional
Enrollment
520 (estimated)
Sponsor
Jiangsu Hansoh Pharmaceutical Co., Ltd. · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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 patients with advanced solid tumors.

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

Conditions

Interventions

TypeNameDescription
DRUGHS-10529Participants in all subjucts will receive HS-10529

Timeline

Start date
2025-05-15
Primary completion
2029-04-30
Completion
2029-08-30
First posted
2025-05-09
Last updated
2025-05-09

Source: ClinicalTrials.gov record NCT06963398. Inclusion in this directory is not an endorsement.