A Phase I Study of HS-10386 in Participants With Advanced Solid Tumors

This is a phase I open label, multicenter clinical study to evaluate the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of HS-10386 in subjects with advanced solid tumors.

Inclusion criteria

• Male or female, 18-75 years old.
• 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.
• At least one measurable lesion per RECIST v1.1.
• Willingness to provide fresh or archival tumor biopsy sample.
• 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.
• Willingness to use adequate contraceptive measures throughout the study.
• Ability to comprehend and willingness to sign a written ICF for the study.

Exclusion criteria

• Treatment with any of the following:

• Previous or current treatment with systemic immunotherapy.
• Treatment with anticancer medications or investigational drugs within protocol-defined intervals prior to the first scheduled dose of HS-10386.
• Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 except for alopecia.
• Known additional malignancy.
• History or risk of autoimmune disease.
• Known primary CNS malignancy or symptomatic CNS metastases. Patients with asymptomatic CNS metastases may be enrolled after consultation.
• Inadequate bone marrow reserve or organ function.
• Clinically significant cardiac disease.
• Any evidence of severe or uncontrolled systemic diseases
• 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.
• History of organ transplantation or any medical condition requiring the use of systemic immunosuppressive medications.
• Active HBV or HCV infection that requires treatment.
• Known history of HIV.
• Women who are breastfeeding or have a positive urine or serum pregnancy test at the Screening Visit.
• 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.
• History of severe anaphylaxis or allergic to any of the components of HS-10386.
• Any disease or condition that, in the opinion of the investigator, would compromise the safety of the patient or interfere with study assessments.