Actively Recruiting
A Phase I Study of HS-10386 in Participants With Advanced Solid Tumors
Led by Jiangsu Hansoh Pharmaceutical Co., Ltd. · Updated on 2023-06-22
248
Participants Needed
1
Research Sites
243 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Phase I Study of HS-10386 in Participants With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, 18-75 years old
- Histologically or cytologically documented incurable or metastatic solid tumors with no effective or available standard treatment
- At least one measurable lesion according to RECIST v1.1
- Willingness to provide a fresh or archival tumor biopsy sample
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 with no worsening over the past 2 weeks and life expectancy of at least 12 weeks
- Willingness to use effective contraception throughout the study
- Ability to understand and sign the study informed consent form
You will not qualify if you...
- Previous or current systemic immunotherapy treatment
- Treatment with anticancer or investigational drugs within protocol-defined intervals before first HS-10386 dose
- Unresolved toxicities greater than CTCAE Grade 2 from prior therapy except alopecia
- Known additional malignancy
- History or risk of autoimmune disease
- Known primary central nervous system malignancy or symptomatic CNS metastases (asymptomatic allowed after consultation)
- Inadequate bone marrow or organ function
- Clinically significant heart disease
- Severe or uncontrolled systemic diseases
- Severe infections within 4 weeks or infection symptoms within 2 weeks prior to first dose
- History of organ transplantation or need for systemic immunosuppressive medication
- Active hepatitis B or C infection requiring treatment
- Known HIV infection
- Women who are breastfeeding or have a positive pregnancy test at screening
- Live attenuated vaccine within 4 weeks prior to first dose or anticipated during the study
- History of severe allergic reaction to HS-10386 components
- Any condition that may compromise patient safety or interfere with study assessments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China, 200030
Actively Recruiting
Research Team
X
Xingxing Liu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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