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NCT Number: NCT06963398

A Study of HS-10529 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.

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Key information

Conditions

Advanced Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HS-10529

Drug

Participants in all subjucts will receive HS-10529

Primary outcomes

  1. The maximum tolerated dose (MTD) or maximum applicable dose (MAD)

    Time frame: up to 24 months

Secondary outcomes

  1. Incidence and severity of treatment-emergent adverse events

    Time frame: up to 24 months

  2. Plasma concentration of HS-10529

    Time frame: up to 36 months

Study contacts

Contact information is provided by the study sponsor or research team.

Fangbin Liu

CONTACT

[email protected]

19916299227

Sponsors and collaborators

Lead sponsor

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
May 9, 2025
Registry last updated
May 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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