Actively Recruiting
HS-20089 Combination Treatment in Subjects With Advanced Solid Tumors
Led by Hansoh BioMedical R&D Company · Updated on 2024-07-18
1048
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
HS-20089 is an investigational antibody-drug conjugate (ADC) composed of a humanized IgG1 anti-B7-H4 monoclonal antibody conjugated to the topoisomerase I inhibitor payload via a protease-cleavable linker, with an average drug-to-antibody ratio of about 6. This is a phase Ⅰ, open-label, multi-center study to evaluate the safety, tolerability, pharmacokinetics (PK) and efficacy of HS-20089 in combination with other antitumor agents (Adebrelimab with or without platinum; Bevacizumab with or without platinum) in subjects with advanced solid tumors.
CONDITIONS
Official Title
HS-20089 Combination Treatment in Subjects With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- Diagnosed with pathologically confirmed advanced solid tumors
- Have at least one target lesion assessed by RECIST 1.1, excluding those with only brain or bone lesions
- Agree to provide fresh or archival tumor tissue
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1 with no decline within 2 weeks before first dose
- Life expectancy of at least 12 weeks
- Female participants of childbearing potential willing to use contraception and not breastfeed from consent until 6 months after last dose; male participants agree to use barrier contraception from consent until 6 months after last dose
- Female participants have a negative pregnancy test within 7 days before first dose or no risk of pregnancy
- Voluntary enrollment with ability to understand study and sign informed consent
You will not qualify if you...
- Received or currently receiving B7-H4-targeted therapies
- Received cytotoxic chemotherapy, investigational drugs, anti-tumor traditional Chinese medicines, or other anti-tumor drugs within 14 days before first dose or need to continue during study
- Have Grade 2 or higher toxicities from prior anti-tumor therapy
- Have pleural or abdominal effusion needing clinical intervention
- History of other primary malignancy
- Evidence of brain metastasis or cancerous meningitis
- Inadequate bone marrow, liver, or kidney function
- Abnormal cardiological examination
- Severe, uncontrolled, or active cardiovascular disorders
- Serious or poorly controlled diabetes or hypertension
- Significant bleeding symptoms or tendency within 1 month before first dose
- Serious infections within 4 weeks before first dose
- Systemic glucocorticoid therapy longer than 7 days within 28 days before first dose, or require chronic use during study, or have immunodeficiency or organ transplantation history
- Active infectious diseases including hepatitis B or C, tuberculosis, syphilis, HIV
- Current hepatic encephalopathy, hepatorenal syndrome, or severe cirrhosis (Child-Pugh Class B or worse)
- Moderate or severe lung diseases affecting detection or treatment of pulmonary toxicity
- History of severe neurological or psychiatric disorders
- Pregnant or breastfeeding women or those intending pregnancy during study
- Attenuated live vaccination within 4 weeks before first dose
- Active or likely recurrent autoimmune disease
- Gastrointestinal fistula, perforation, abscess, or intestinal obstruction symptoms within 6 months before first dose
- Unlikely to comply with study procedures as determined by investigator
- Any condition jeopardizing safety or assessment as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Shanghai, Shanghai Municipality, China, 430000
Actively Recruiting
Research Team
D
Ding Ma, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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