Actively Recruiting
ARTEMIS-006: HS-20093 in Patients With Head and Neck Squamous Cell Carcinoma and Other Solid Tumors
Led by Hansoh BioMedical R&D Company · Updated on 2024-08-20
170
Participants Needed
25
Research Sites
207 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
HS-20093 is a fully humanized IgG1 antibody-drug conjugate (ADC) which specifically binds to B7-H3, a target wildly expressed on solid tumor cells. This is a phase 2, open-label, multi-center study to evaluate the efficacy, safety, pharmacokinetics (PK) and immunogenicity of HS-20093 as a monotherapy in patients with head and neck squamous cell carcinoma and other solid tumors.
CONDITIONS
Official Title
ARTEMIS-006: HS-20093 in Patients With Head and Neck Squamous Cell Carcinoma and Other Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years old at screening
- Histologically confirmed recurrent or metastatic head and neck squamous cell carcinoma or other solid tumor
- Disease progressed on or intolerant to standard therapies
- At least one measurable lesion according to RECIST 1.1
- Agree to provide fresh or archival tumor tissue and peripheral blood samples
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1
- Life expectancy of at least 12 weeks
- Men and women must use adequate contraception during the study
- Female participants must not be pregnant or have evidence of non-childbearing potential
- Signed and dated informed consent form
You will not qualify if you...
- Previous or current treatment with B7-H3 targeted therapy
- Cytotoxic chemotherapy, investigational agents, or small molecule targeted therapy within 14 days before first dose
- Macromolecule anti-tumor therapy or other anticancer drugs within 28 days before first dose
- Radiotherapy for palliation within 2 weeks or extensive radiotherapy within 4 weeks before first dose
- Pleural or peritoneal effusion needing clinical intervention or pericardial effusion
- Major surgery within 4 weeks before first dose
- Spinal cord compression or brain metastases
- Treatment with strong CYP3A4 inhibitors, inducers, or sensitive substrates within 7 days before first dose or during study
- Drugs known to prolong QT interval or cause torsade de pointe before or during study
- Unresolved toxicities from prior therapy greater than Grade 2 except stable hypothyroidism, alopecia, or neurotoxicity
- History of other primary cancers
- Inadequate bone marrow or organ function
- Evidence of cardiovascular risk or severe uncontrolled cardiovascular diseases
- Diabetes ketoacidosis or hyperglycemia within 6 months before first dose or HbA1c ≥ 7.5%
- Severe or poorly controlled hypertension
- Significant bleeding symptoms or recent serious thrombosis events
- Severe infections within 4 weeks before first dose
- Continuous steroid treatment for more than 30 days before first dose or need for long-term steroids
- Known active infections like hepatitis B, hepatitis C, tuberculosis, syphilis, or HIV
- Severe liver disease including hepatic encephalopathy or Child-Pugh Grade B or worse cirrhosis
- Moderate or severe lung diseases affecting pulmonary function
- History of serious neurological or mental disorders affecting assessments
- Women who are breastfeeding, pregnant, or planning pregnancy during study
- Vaccination or hypersensitivity reactions within 4 weeks before first dose
- History of severe hypersensitivity or allergy to human or mouse derived proteins
- Hypersensitivity to any ingredient of HS-20093
- Unlikely to comply with study procedures or safety concerns according to investigator
- Any condition compromising safety or study assessments per investigator opinion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 25 locations
1
Anhui Cancer Hospital
Hefei, Anhui, China
Actively Recruiting
2
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
3
Beijing Tongren Hospital, CMU
Beijing, Beijing Municipality, China
Actively Recruiting
4
Fujian Cancer Hospital
Fuzhou, Fujian, China
Actively Recruiting
5
Sun Yai-Sen Memorial Hospital Sun Yai-Sen University
Guangzhou, Guangdong, China
Actively Recruiting
6
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
Actively Recruiting
7
The Fifth Affiliated Hospital Sun Yat-Sen University
Zhuhai, Guangdong, China
Actively Recruiting
8
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China
Actively Recruiting
9
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Actively Recruiting
10
Henan Cancer Hospital
Zhengzhou, Henan, China
Actively Recruiting
11
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Actively Recruiting
12
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Wuhan, Hubei, China
Actively Recruiting
13
Hunan Cancer Hospital
Changsha, Hunan, China
Actively Recruiting
14
The Second XIANGYA Hospital Of Central South University
Changsha, Hunan, China
Actively Recruiting
15
The Second Hospital of Dalian Medical University
Dalian, Liaoning, China
Not Yet Recruiting
16
Liaoning Cancer Hospital
Shenyang, Liaoning, China
Actively Recruiting
17
Cancer Hospital of Shandong First Medical University
Jinan, Shandong, China
Actively Recruiting
18
Shanghai East Hospital
Shanghai, Shanghai Municipality, China, 200120
Actively Recruiting
19
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Shanghai, Shanghai Municipality, China
Actively Recruiting
20
The first Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China
Actively Recruiting
21
Sichuan Cancer Hospital
Chengdu, Sichuan, China
Actively Recruiting
22
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Actively Recruiting
23
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, China
Actively Recruiting
24
Cancer hospital of Xinjiang medical University
Xinjiang, Xinjiang, China
Actively Recruiting
25
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
S
Siwei Bao
CONTACT
Y
Ye Guo, MD
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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