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

A Phase I Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of HS387 in Subjects With Advanced Solid Tumors

Doctors are testing a new drug called HS387 to see if it is safe and helps adults with advanced solid tumors who have exhausted or cannot tolerate standard treatments.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 110 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Zhejiang Hisun Pharmaceutical Co. Ltd. (Industry-sponsored)
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT07092748 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults 18–75 with advanced solid tumors who have progressed on or cannot tolerate standard treatments, have ECOG performance status 0–1, expected survival ≥3 months, adequate organ function, and at least one evaluable/measurable lesion are ideal candidates.

Not a fit: Patients outside the 18–75 age range, with ECOG ≥2, inadequate organ function, active pregnancy, or without evaluable/measurable lesions are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, HS387 could provide a new treatment option with acceptable safety and measurable anti-tumor activity for patients with advanced solid tumors who have no standard therapies left.

How similar studies have performed: Dose-escalation followed by expansion cohorts is a common early-phase approach and has identified effective regimens for other agents, but HS387 itself is an early-phase investigational agent with unproven clinical benefit.

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.

Where this trial is running

Hangzhou, Zhejiang

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

Study contacts

• Study coordinator: Wei Qu

Conditions Advanced Solid Cancers