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

Recruiting now · Phase 1

Conditions studied: Advanced Solid Cancers

In brief

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)

Key facts

Study ID

NCT07092748

Run by

Zhejiang Hisun Pharmaceutical Co. Ltd.

People needed

110

Starts

2025-07-15

Expected to finish

2028-12-31

Last updated by the study team

2025-07-30

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must meet all of the following inclusion criteria to be eligible for participation in this study:
• Men or women ≥18 years old and ≤75 years old.
• Subjects with advanced solid tumors who have failed or are intolerant to standard treatment, or have no standard therapy.
• Survival expectation is ≥ 3 months.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
• 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.
• Subjects with adequate organ function at the time of screening.
• 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.

You may not qualify if…

• Subjects will be excluded if they meet any of the following criteria:
• Has received other investigational drugs or treatments not yet approved for marketing within 4 weeks prior to the first administration.
• Has active infection.
• Has meningeal metastases or symptomatic central nervous system (CNS) metastases.
• Significant impairment of oral drug absorption.
• Has interstitial lung disease.
• Pregnant or lactating women.
• Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
• Has a major surgical procedure within 4 weeks prior to the first administration.
• Has a treatment history of KIF18A inhibitor.
• In the opinion of the Investigator, there are other factors that the subject is unsuitable for participation in this clinical study.

Where it is running

• Zhejiang Cancer hospital — Hangzhou, Zhejiang, China (enrolling)

Full record on ClinicalTrials.gov

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