NCT06963398

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
520

participants targeted

Target at P75+ for phase_1

Timeline
39mo left

Started May 2025

Longer than P75 for phase_1

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress25%
May 2025Aug 2029

First Submitted

Initial submission to the registry

April 29, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 9, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

May 15, 2025

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2029

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2029

Last Updated

May 9, 2025

Status Verified

May 1, 2025

Enrollment Period

4 years

First QC Date

April 29, 2025

Last Update Submit

May 6, 2025

Conditions

Advanced Solid Tumors

Keywords

Advanced Solid TumorsKRAS G12D

Outcome Measures

Primary Outcomes (1)

  • The maximum tolerated dose (MTD) or maximum applicable dose (MAD)

    up to 24 months

Secondary Outcomes (2)

  • Incidence and severity of treatment-emergent adverse events

    up to 24 months

  • Plasma concentration of HS-10529

    up to 36 months

Study Arms (1)

HS-10529

EXPERIMENTAL
Drug: HS-10529

Interventions

HS-10529DRUG

Participants in all subjucts will receive HS-10529

HS-10529

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Fangbin Liu

CONTACT

19916299227liufb@hspharm.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2025

First Posted

May 9, 2025

Study Start

May 15, 2025

Primary Completion (Estimated)

April 30, 2029

Study Completion (Estimated)

August 30, 2029

Last Updated

May 9, 2025

Record last verified: 2025-05