Testing HS-10386 for advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase I clinical trial evaluates the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of HS-10386 in participants with advanced solid tumors who have not responded to previous treatments. The study is open-label and multicenter, allowing for a diverse participant pool. Eligible patients will receive HS-10386 and will be monitored for any adverse effects and treatment efficacy.

Why it matters

Who can join: the full rules

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.

Where it's running

• Shanghai Chest Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Shun Lu, Dr. — Shanghai Chest Hospital
• Study coordinator: Xingxing Liu
• Email: liuxx2@hspharm.com
• Phone: +86 18652105536

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.