A Phase Ia/ Ib Study of HS387 in Subjects With Advanced S... | NCT07092748

Studies
A Phase Ia/ Ib Study of HS387 in Subjects With Advanced Solid Tumors

NCT07092748

Sponsor

Zhejiang Hisun Pharmaceutical Co. Ltd.

Status

Recruiting

Last Update Posted

Jul 30, 2025Actual

Enrollment

110Estimated

Phase

Phase 1

Conditions

Advanced Solid Cancers

Interventions

HS387

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 15, 2025Actual

Primary Completion Date

Jun 30, 2028Estimated

Completion Date

Dec 31, 2028Estimated

First Submitted Date

Jul 22, 2025

First Submission Date that Met QC Criteria

Jul 22, 2025

First Posted Date

Jul 30, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 22, 2025

Last Update Posted Date

Jul 30, 2025Actual

Label	Type	Description	Intervention Names
HS387 group	Experimental		Drug: HS387

Name	Type	Description	Arm Group Labels	Other Names
HS387	Drug	HS387 tablets will be given orally	HS387 group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants Reporting Adverse Events (AEs) or Serious Adverse Events (SAEs)	Adverse events (AE), serious adverse events (SAE), and severity of AE using the NCI-CTCAE version 5.0	2 years
Dose-limiting Toxicities Incidence Count Among Study Participant	DLT refers to Dose-Limiting Toxicity. It is defined as a side effect or adverse reaction of a drug or treatment that is severe enough to prevent an increase in dosage. Identifying DLT is crucial in clinical trials for determining the maximum tolerated dose (MTD) of a new drug.	2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to be eligible for participation in this study:
1. Men or women ≥18 years old and ≤75 years old.
2. Subjects with advanced solid tumors who have failed or are intolerant to standard treatment, or have no standard therapy.
3. Survival expectation is ≥ 3 months.
4. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
5. Phase Ⅰa: Subjects with advanced solid tumors have at least one evaluable lesion according to RECIST 1.1. Phase Ⅰb: Subjects with advanced solid tumors have at least one measurable lesion according to RECIST 1.1.
6. Subjects with adequate organ function at the time of screening.
7. Serum pregnancy test (for female of childbearing potential) negative prior to first dosing of study treatment. Male and female subjects of childbearing potential must agree to use effective methods of contraception throughout the study and for 3 months after the last dose of the investigational product.
  
  Exclusion Criteria:
Subjects will be excluded if they meet any of the following criteria:
1. Has received other investigational drugs or treatments not yet approved for marketing within 4 weeks prior to the first administration.
2. Has active infection.
3. Has meningeal metastases or symptomatic central nervous system (CNS) metastases.
4. Significant impairment of oral drug absorption.
5. Has interstitial lung disease.
6. Pregnant or lactating women.
7. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
8. Has a major surgical procedure within 4 weeks prior to the first administration.
9. Has a treatment history of KIF18A inhibitor.
10. In the opinion of the Investigator, there are other factors that the subject is unsuitable for participation in this clinical study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided