A Phase Ia/ Ib Study of HS387 in Subjects With Advanced Solid Tumors

NCT07092748 | Recruiting Phase 1

• 1 other identifier: HS387-I-01
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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

Advanced Solid Cancers

Outcome Measures

Primary Outcomes (2)

• Number of Participants Reporting Adverse Events (AEs) or Serious Adverse Events (SAEs)

  Adverse events (AE), serious adverse events (SAE), and severity of AE using the NCI-CTCAE version 5.0

  2 years

• Dose-limiting Toxicities Incidence Count Among Study Participant

  DLT refers to Dose-Limiting Toxicity. It is defined as a side effect or adverse reaction of a drug or treatment that is severe enough to prevent an increase in dosage. Identifying DLT is crucial in clinical trials for determining the maximum tolerated dose (MTD) of a new drug.

  2 years

Study Arms (1)

HS387 group

EXPERIMENTAL

Drug: HS387

Interventions

HS387 DRUG

HS387 tablets will be given orally

HS387 group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang Hisun Pharmaceutical Co. Ltd.: lead

Study Sites (1)

Zhejiang Cancer hospital

Hangzhou, Zhejiang, China

RECRUITING

Central Study Contacts

WEI QU

CONTACT

8618067913551; wei.qu@hisunpharm.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: July 30, 2025
• Study Start: July 15, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 30, 2025

Record last verified: 2025-07

Locations

CN (1)