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

NCT ID: NCT07092748

Last Updated: 2025-07-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-15
• Study Completion Date: 2028-12-31

Brief Summary

This is a Phase Ia/Ib, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, and preliminary efficacy of HS387 in subjects with advanced solid tumors. It includes two parts: the dose escalation study (Phase Ia) and the dose expansion study (Phase Ib)

Conditions

Advanced Solid Cancers

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HS387 group

Group Type: EXPERIMENTAL

HS387

Intervention Type: DRUG

HS387 tablets will be given orally

Interventions

HS387

HS387 tablets will be given orally

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang Hisun Pharmaceutical Co. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Zhejiang Cancer hospital

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

WEI QU

Role: CONTACT

wei.qu@hisunpharm.com

8618067913551

Facility Contacts

Zhengbo Song, doctorate

Role: primary

zjccgcp_phase1@126.com

8613857153345

Other Identifiers

HS387-I-01

Identifier Type: -

Identifier Source: org_study_id