A Phase Ia/ Ib Study of HS387 in Subjects With Advanced Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HS387.
- Who it may be relevant to
- Registry conditions: Advanced Solid Cancers. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase I Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of HS387 in Subjects With Advanced Solid Tumors
Overview
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)
Interventions
- Drug HS387
HS387 tablets will be given orally
Primary outcome measures
- Number of Participants Reporting Adverse Events (AEs) or Serious Adverse Events (SAEs) [Time frame: 2 years]
- Dose-limiting Toxicities Incidence Count Among Study Participant [Time frame: 2 years]
Eligibility criteria
Inclusion criteria
- Subjects must meet all of the following inclusion criteria to be eligible for participation in this study:
- Men or women ≥18 years old and ≤75 years old.
- Subjects with advanced solid tumors who have failed or are intolerant to standard treatment, or have no standard therapy.
- Survival expectation is ≥ 3 months.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
- 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.
- Subjects with adequate organ function at the time of screening.
- 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:
- Has received other investigational drugs or treatments not yet approved for marketing within 4 weeks prior to the first administration.
- Has active infection.
- Has meningeal metastases or symptomatic central nervous system (CNS) metastases.
- Significant impairment of oral drug absorption.
- Has interstitial lung disease.
- Pregnant or lactating women.
- Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
- Has a major surgical procedure within 4 weeks prior to the first administration.
- Has a treatment history of KIF18A inhibitor.
- In the opinion of the Investigator, there are other factors that the subject is unsuitable for participation in this clinical study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Zhejiang Cancer hospital — Hangzhou
Identifiers
NCT: NCT07092748 · HS387-I-01