Testing HS387 in adults with advanced solid tumors (Phase Ia/Ib)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase Ia/Ib trial follows a dose-escalation (Phase Ia) then dose-expansion (Phase Ib) design to identify safe dose levels and gather early signs of anti-tumor activity. Participants are adults aged 18–75 with advanced solid tumors, ECOG 0–1, and at least one evaluable or measurable lesion per RECIST 1.1. The study will collect safety, tolerability, pharmacokinetics, and preliminary efficacy data after administering HS387. Enrollment and treatments are conducted at Zhejiang Cancer Hospital in Hangzhou, Zhejiang.

Why it matters

Who can join: the full rules

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.

Where it's running

• Zhejiang Cancer hospital
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Wei Qu
• Email: wei.qu@hisunpharm.com
• Phone: 8618067913551

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.