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Recruiting Phase 1

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

NCT07092748 · tracked via the Priya Life Science China tracker
Sponsor
Zhejiang Hisun Pharmaceutical Co. Ltd
Phase
Phase 1
Started
2025-07-15
Last updated
2025-07-30

Condition(s) studied

Advanced Solid Cancers

Investigational drug(s) / intervention(s)

HS387

HS387: HS387 tablets will be given orally

Study 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)

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Number of Participants Reporting Adverse Events (AEs) or Serious Adverse Events (SAEs) — 2 years
    Adverse events (AE), serious adverse events (SAE), and severity of AE using the NCI-CTCAE version 5.0
  • Dose-limiting Toxicities Incidence Count Among Study Participant — 2 years
    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.

Trial sites (1)

FacilityCityRegionStatus
Zhejiang Cancer hospital Hangzhou Zhejiang Recruiting

More Zhejiang Hisun Pharmaceutical Co. Ltd. trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07092748 on ClinicalTrials.gov ↗ ← All trials in China