Actively Recruiting
A Study of HS-20089 in Patients With Advanced Solid Tumors
Led by Shanghai Hansoh Biomedical Co., Ltd · Updated on 2024-04-03
177
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
HS-20089 is a novel DAR-6 antibody-drug conjugate （ADC） targeting B7-H4. In preclinical studies, it inhibited tumor cell growth expressing B7-H4 in vitro and in vivo. The first-in-human trial is conducted to assess the maximum tolerated dose (MTD) and dose limiting toxicity (DLT), to evaluate the pharmacokinetics, safety and preliminary anti-tumor activity of HS-20089 in Patients With Advanced Solid Tumors.
CONDITIONS
Official Title
A Study of HS-20089 in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men or women aged 18 years or older
- Confirmed advanced solid tumor by histology or cytology with no valid, available, or tolerable standard treatment
- At least one measurable target lesion with diameter ≥ 10 mm or lymph node shortest axis ≥ 15 mm
- ECOG performance status of 0 or 1 without deterioration in the previous 2 weeks
- Estimated life expectancy greater than 12 weeks
- Females must use adequate contraception, not be breastfeeding during the study and for 3 months after, and have non-childbearing potential
- Signed informed consent form
You will not qualify if you...
- Previous or current treatment with drugs targeting B7-H4
- Cytotoxic chemotherapy, investigational agents, or anticancer drugs within 28 days before first study dose
- Radiotherapy to limited area within 2 weeks, or large-scale or >30% bone marrow irradiation within 4 weeks before first study dose
- Major surgery within 4 weeks before first study dose
- Known untreated or active central nervous system metastases
- Existing abnormal CTCAE grade ≥ 2 from previous treatment
- History of other malignancy
- Inadequate bone marrow or organ function
- Active or untreated hepatitis B or C, or known HIV infection
- Hypersensitivity to any component of HS-20089
- Investigator judgment of inability to comply with study procedures or safety concerns
- Any disease or condition that may compromise safety or study assessments
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
J
Jiong Wu, PhD
CONTACT
J
Jian Zhang, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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