NCT05911464 A Phase I Study of HS-10386 in Participants With Advanced Solid Tumors
| NCT ID | NCT05911464 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Jiangsu Hansoh Pharmaceutical Co., Ltd. |
| Condition | Advanced Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 248 participants |
| Start Date | 2023-03-02 |
| Primary Completion | 2025-10-31 |
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 248 participants in total. It began in 2023-03-02 with a primary completion date of 2025-10-31.
⚠ 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
The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, and preliminary anti-tumor activity of HS-10386 in participants with advanced solid tumors who have failed prior treatments.
Eligibility Criteria
Inclusion Criteria: 1. Male or female, 18-75 years old. 2. Histologically or cytologically documented, incurable or metastatic solid tumors for which standard treatment either does not exist or has proven ineffective or unavailable or intolerable. 3. At least one measurable lesion per RECIST v1.1. 4. Willingness to provide fresh or archival tumor biopsy sample. 5. An Eastern Cooperative Oncology Group (ECOG) performance status equal to 0-1 with no deterioration over the previous 2 weeks and a minimum life expectancy of 12 weeks. 6. Willingness to use adequate contraceptive measures throughout the study. 7. Ability to comprehend and willingness to sign a written ICF for the study. Exclusion Criteria: 1. Treatment with any of the following: 1. Previous or current treatment with systemic immunotherapy. 2. Treatment with anticancer medications or investigational drugs within protocol-defined intervals prior to the first scheduled dose of HS-10386. 2. Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 except for alopecia. 3. Known additional malignancy. 4. History or risk of autoimmune disease. 5. Known primary CNS malignancy or symptomatic CNS metastases. Patients with asymptomatic CNS metastases may be enrolled after consultation. 6. Inadequate bone marrow reserve or organ function. 7. Clinically significant cardiac disease. 8. Any evidence of severe or uncontrolled systemic diseases 9. Severe infections within 4 weeks prior to the first scheduled dose or symptoms of infection within 2 weeks prior to prior to the first scheduled dose. 10. History of organ transplantation or any medical condition requiring the use of systemic immunosuppressive medications. 11. Active HBV or HCV infection that requires treatment. 12. Known history of HIV. 13. Women who are breastfeeding or have a positive urine or serum pregnancy test at the Screening Visit. 14. Administration of a live, attenuated vaccine within 4 weeks prior to the first scheduled dose or anticipation that such a live attenuated vaccine will be required during the study. 15. History of severe anaphylaxis or allergic to any of the components of HS-10386. 16. Any disease or condition that, in the opinion of the investigator, would compromise the safety of the patient or interfere with study assessments.
Contact & Investigator
Shun Lu, Dr.
PRINCIPAL INVESTIGATOR
Shanghai Chest Hospital
Frequently Asked Questions
Who can join the NCT05911464 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Advanced Solid Tumor. 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 NCT05911464 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 NCT05911464 currently recruiting?
Yes, NCT05911464 is actively recruiting participants. Contact the research team at liuxx2@hspharm.com for enrollment information.
Where is the NCT05911464 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT05911464 clinical trial?
NCT05911464 is sponsored by Jiangsu Hansoh Pharmaceutical Co., Ltd.. The principal investigator is Shun Lu, Dr. at Shanghai Chest Hospital. The trial plans to enroll 248 participants.