NCT07092748 A Phase Ia/ Ib Study of HS387 in Subjects With Advanced Solid Tumors
| NCT ID | NCT07092748 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Zhejiang Hisun Pharmaceutical Co. Ltd. |
| Condition | Advanced Solid Cancers |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2025-07-15 |
| Primary Completion | 2028-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 110 participants in total. It began in 2025-07-15 with a primary completion date of 2028-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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)
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07092748 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Advanced Solid Cancers. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07092748 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07092748 currently recruiting?
Yes, NCT07092748 is actively recruiting participants. Contact the research team at wei.qu@hisunpharm.com for enrollment information.
Where is the NCT07092748 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT07092748 clinical trial?
NCT07092748 is sponsored by Zhejiang Hisun Pharmaceutical Co. Ltd.. The trial plans to enroll 110 participants.
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