Actively Recruiting
A Phase I Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of HS387 in Subjects With Advanced Solid Tumors
Led by Zhejiang Hisun Pharmaceutical Co. Ltd. · Updated on 2025-07-30
110
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating HS387 in a Phase Ia/Ib clinical trial to study its safety, tolerability, pharmacokinetics, and preliminary antitumor activity in adults with advanced solid tumors. The trial includes two parts: a dose escalation phase (Phase Ia) to find the appropriate dose, followed by a dose expansion phase (Phase Ib) to further assess the treatment in more participants. The study is sponsored by Zhejiang Hisun Pharmaceutical Co. Ltd. and focuses on participants who have limited treatment options for their cancer. Participants will receive HS387 tablets taken orally in the experimental group. The study begins with dose escalation to determine the best dose and proceeds to dose expansion to evaluate the treatment further. There is no placebo group, and the study is not blinded. The trial runs from July 2025 to December 2028. During the study, participants will undergo regular medical assessments including monitoring for adverse events and dose-limiting toxicities over a 2-year period. Researchers will measure safety outcomes such as the number of participants reporting side effects and serious adverse events. Participants’ tumor lesions will be evaluated by RECIST criteria, and their overall health and organ function will be monitored throughout the trial.
CONDITIONS
Brief Title
A Phase Ia/ Ib Study of HS387 in Subjects With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men or women aged 18 to 75 years
- Diagnosed with advanced solid tumors that have failed or are intolerant to standard treatment, or have no standard therapy
- Expected survival of at least 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Phase Ia: At least one evaluable lesion by RECIST 1.1; Phase Ib: At least one measurable lesion by RECIST 1.1
- Adequate organ function at screening
- Negative pregnancy test for females of childbearing potential prior to first dosing
- Agreement to use effective contraception during the study and for 3 months after last dose for males and females of childbearing potential
You will not qualify if you...
- Received other investigational drugs or unapproved treatments within 4 weeks before first dose
- Active infection
- Meningeal metastases or symptomatic central nervous system metastases
- Significant problems with oral drug absorption
- Interstitial lung disease
- Pregnant or breastfeeding women
- History of allogeneic organ or hematopoietic stem cell transplantation
- Major surgery within 4 weeks before first dose
- Previous treatment with KIF18A inhibitor
- Any other condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants receive HS387 tablets orally as part of the treatment for advanced solid tumors.
Regular visits during treatment as scheduled by the study team
Trial Site Locations
Total: 1 location
1
Zhejiang Cancer hospital
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
W
WEI QU
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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