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

NCT ID: NCT06963398

Last Updated: 2025-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

520 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-15

Study Completion Date

2029-08-30

Brief Summary

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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

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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

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Advanced Solid Tumors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HS-10529

Group Type EXPERIMENTAL

HS-10529

Intervention Type DRUG

Participants in all subjucts will receive HS-10529

Interventions

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HS-10529

Participants in all subjucts will receive HS-10529

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jiangsu Hansoh Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Fangbin Liu

Role: CONTACT

19916299227

Other Identifiers

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HS-10529-101

Identifier Type: -

Identifier Source: org_study_id

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