Trial Title:
HS-20093 in Patients With Advanced Esophageal Carcinoma and Other Advanced Solid Tumors
NCT ID:
NCT06112704
Condition:
Advanced Solid Tumor
Conditions: Official terms:
Carcinoma
Esophageal Neoplasms
Conditions: Keywords:
Advanced solid tumor
Esophageal Carcinoma
B7-H3
antibody-drug conjugate (ADC)
HS-20093
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
HS-20093
Description:
Intravenous (IV) infusion of HS-20093 Q3W; Participants will receive continuous treatment
until the end of the study in the absence of unacceptable toxicities and confirmed
disease progression.
Arm group label:
Phase IIa: Cohort 1
Arm group label:
Phase IIa: Cohort 2
Arm group label:
Phase IIa: Cohort 3
Arm group label:
Phase IIb
Summary:
HS-20093 is a humanized IgG1 antibody-drug conjugate (ADC) which specifically binds to
B7-H3, a target wildly expressed on solid tumor cells. The objectives of this study are
to investigate the anti-tumor activity, safety, pharmacokinetics and immunogenicity of
HS-20093 in Chinese advanced esophageal carcinoma and other solid tumor patients.
Detailed description:
This is an open-label, multi-center phase 2 study in Chinese adult participants with
recurrent, locally advanced or metastatic esophageal carcinoma or other advanced solid
tumors, which is designed to investigate the efficacy, safety, pharmacokinetics and
immunogenicity of HS-20093. This study will consist of two parts: phase IIa and phase
IIb.
Part 1 (phase IIa) will conducted in participants with relapsed, locally advanced or
metastatic esophageal carcinoma and other advanced solid tumor. Subjects will receive one
dose levels of HS-20093 intravenously every 3 weeks.
Part 2 (phase IIb) will enroll participants with relapsed, locally advanced or metastatic
esophageal squamous cell carcinoma. One dose levels of HS-20093 will be administered as
an intravenous (IV) infusion every 3 weeks.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Men or women aged more than or equal to (≥) 18 years.
2. Histologically or cytologically confirmed, relapsed, locally advanced or metastatic
esophageal carcinomas and other advanced solid tumor.
3. At least one extra measurable lesion according to RECIST 1.1 (cavity structures such
as oesophagus cannot serve as measurable lesions).
4. Agree to provide fresh or archival tumor tissue and blood samples.
5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0~1.
6. Estimated life expectancy >12 weeks.
7. Agree to use medically accepted methods of contraception.
8. Men or women should be using adequate contraceptive measures throughout the study.
9. Females subjects must not be pregnant at screening or have evidence of
non-childbearing potential.
10. Signed and dated Informed Consent Form.
Exclusion Criteria:
Any of the following would exclude the subject from participation in the study:
1. Treatment with any of the following:
Previous or current treatment with B7-H3 targeted therapy Any cytotoxic
chemotherapy, investigational agents and anticancer drugs within 14 days prior to
the first scheduled dose of HS-20093 Prior treatment with a monoclonal antibody
within 28 days prior to the first scheduled dose of HS-20093 Local radiotherapy for
palliation within 2 weeks of the first dose of study drug, or patients received more
than 30% of the bone marrow irradiation, or large-scale radiotherapy within 4 weeks
prior to the first scheduled dose of HS-20093 Major surgery within 4 weeks prior to
the first scheduled dose of HS-20093
2. Subjects with previous or concurrent malignancies
3. Significant tumor invasion into adjacent organs (aorta or trachea) of esophageal
lesions leading to higher risk of bleeding or fistula
4. Inadequate bone marrow reserve or organ dysfunction.
5. Evidence of cardiovascular risk
6. Evidence of current severe or uncontrolled systemic diseases
7. Evidence of mucosal or internal bleeding within 1 month prior to the first scheduled
dose of HS-20093
8. Severe infections occured within 4 weeks before the first dose
9. The presence of active infectious diseases has been known before first dose such as
hepatitis B, hepatitis C, ect
10. History of neuropathy or mental disorders
11. Pregnant or lactating female
12. History of severe hypersensitivity reaction, severe infusion reaction or
idiosyncrasy to drugs chemically related to HS-20093 or any of the components of
HS-20093
13. Known vaccination or hypersensitivity of any level within 4 weeks prior to the first
scheduled dose of HS-20093
14. Unlikely to comply with study procedures, restrictions, and requirements in the
opinion of the investigator
15. Any disease or condition that, in the opinion of the investigator, would compromise
subject safety or interfere with study assessments
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Anhui Provincial Cancer Hospital
Address:
City:
Hefei
Zip:
230031
Country:
China
Status:
Recruiting
Facility:
Name:
Fujian Provincial Tumor Hospital
Address:
City:
Fujian
Zip:
350014
Country:
China
Status:
Not yet recruiting
Facility:
Name:
The 900th Hospital of the Joint Service Support Force of the Chinese People's Liberation Army
Address:
City:
Fuzhou
Zip:
350014
Country:
China
Status:
Recruiting
Facility:
Name:
Guangdong Provincial People's Hospital
Address:
City:
Guangzhou
Zip:
510000
Country:
China
Status:
Recruiting
Facility:
Name:
Harbin Medical University Cancer Hospital
Address:
City:
Harbin
Zip:
1540000
Country:
China
Status:
Recruiting
Facility:
Name:
Tumour Hospital of Anyang city
Address:
City:
Anyang
Zip:
455000
Country:
China
Status:
Recruiting
Facility:
Name:
The First Affiliated Hospital of Henan University of Science & Technology
Address:
City:
Luoyang
Zip:
471003
Country:
China
Status:
Recruiting
Facility:
Name:
Nanyang Central Hospital
Address:
City:
Nanyang
Zip:
422000
Country:
China
Status:
Recruiting
Facility:
Name:
The First Affiliated Hospital of Xinxiang Medical University
Address:
City:
Xinxiang
Zip:
453100
Country:
China
Status:
Recruiting
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Zip:
450003
Country:
China
Status:
Recruiting
Facility:
Name:
The First Affiliated Hospital of Zhengzhou University
Address:
City:
Zhengzhou
Zip:
450052
Country:
China
Status:
Recruiting
Facility:
Name:
Tongji Hospital, affiliated with Tongji Medical College, Huazhong University of Science and Technology
Address:
City:
Wuhan
Zip:
430030
Country:
China
Status:
Recruiting
Facility:
Name:
Hubei Cancer Hospital
Address:
City:
Wuhan
Zip:
430079
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Nantong Tumor Hospital
Address:
City:
Nantong
Zip:
226300
Country:
China
Status:
Recruiting
Facility:
Name:
Jiangyin People's Hospital
Address:
City:
Wuxi
Zip:
214400
Country:
China
Status:
Recruiting
Facility:
Name:
Jiangxi Provincial Tumor Hospital
Address:
City:
Nanchang
Zip:
330038
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Liaoning Cancer Hospital
Address:
City:
Shenyang
Zip:
110000
Country:
China
Status:
Recruiting
Facility:
Name:
The First Hospital of China Medical University
Address:
City:
Shenyang
Zip:
110002
Country:
China
Status:
Recruiting
Facility:
Name:
Affiliated Hospital of Jining Medical University
Address:
City:
Jining
Zip:
272000
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Sichuan Cancer Hospital&Institude, Sichuan Cancer Center,Affiliate Cancer Hospital Of University Of Electronic Science and Technology of China
Address:
City:
Chengdu
Zip:
610041
Country:
China
Status:
Recruiting
Facility:
Name:
The Affiliated Cancer Hospital of Xinjiang Medical University
Address:
City:
Ürümqi
Zip:
830011
Country:
China
Status:
Recruiting
Start date:
February 6, 2024
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Hansoh BioMedical R&D Company
Agency class:
Industry
Source:
Hansoh BioMedical R&D Company
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06112704
