Actively Recruiting
A Phase Ia/ Ib Study 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
180 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official 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
- Advanced solid tumors with failure, intolerance to standard treatment, or no standard therapy available
- Expected survival of at least 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- At least one evaluable lesion (Phase Ia) or measurable lesion (Phase Ib) per RECIST 1.1
- Adequate organ function at screening
- Negative pregnancy test for females of childbearing potential before 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 investigational drugs or unapproved treatments within 4 weeks before first dose
- Active infection
- Meningeal metastases or symptomatic central nervous system metastases
- Significant problems absorbing oral drugs
- Interstitial lung disease
- Pregnant or lactating women
- History of allogeneic organ or hematopoietic stem cell transplantation
- Major surgery within 4 weeks before first dose
- Previous treatment with KIF18A inhibitor
- Other factors deemed unsuitable by the Investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Zhejiang Cancer hospital
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
W
WEI QU
CONTACT
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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