Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06112704

HS-20093 in Patients with Advanced Esophageal Carcinoma and Other Advanced Solid Tumors

Led by Hansoh BioMedical R&D Company · Updated on 2024-12-02

220

Participants Needed

21

Research Sites

151 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

HS-20093 in Patients with Advanced Esophageal Carcinoma and Other Advanced Solid Tumors

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Men or women aged 18 years or older
  • Histologically or cytologically confirmed relapsed, locally advanced, or metastatic esophageal carcinoma or other advanced solid tumor
  • At least one measurable lesion outside of cavity structures according to RECIST 1.1
  • Agree to provide fresh or archival tumor tissue and blood samples
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1
  • Estimated life expectancy greater than 12 weeks
  • Agree to use medically accepted contraception methods
  • Use adequate contraceptive measures throughout the study
  • Female participants must not be pregnant at screening or have evidence of non-childbearing potential
  • Signed and dated informed consent form
Not Eligible

You will not qualify if you...

  • Previous or current treatment with B7-H3 targeted therapy
  • Any cytotoxic chemotherapy, investigational agents, anticancer drugs within 14 days before first dose
  • Prior treatment with a monoclonal antibody within 28 days before first dose
  • Local radiotherapy for palliation within 2 weeks before first dose or more than 30% bone marrow irradiation
  • Large-scale radiotherapy within 4 weeks before first dose
  • Major surgery within 4 weeks before first dose
  • Previous or concurrent malignancies
  • Significant tumor invasion into adjacent organs (aorta or trachea) increasing bleeding or fistula risk
  • Inadequate bone marrow reserve or organ dysfunction
  • Evidence of cardiovascular risk
  • Current severe or uncontrolled systemic diseases
  • Mucosal or internal bleeding within 1 month before first dose
  • Severe infections within 4 weeks before first dose
  • Active infectious diseases such as hepatitis B or C before first dose
  • History of neuropathy or mental disorders
  • Pregnant or lactating females
  • History of severe hypersensitivity or infusion reactions to HS-20093 or related drugs
  • Vaccination or hypersensitivity within 4 weeks before first dose
  • Unlikely to comply with study procedures or requirements
  • Any condition compromising safety or interfering with assessments as judged by investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 21 locations

1

Anhui Provincial Cancer Hospital

Hefei, Anhui, China, 230031

Actively Recruiting

2

Fujian Provincial Tumor Hospital

Fujian, Fujian, China, 350014

Not Yet Recruiting

3

The 900th Hospital of the Joint Service Support Force of the Chinese People's Liberation Army

Fuzhou, Fujian, China, 350014

Actively Recruiting

4

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China, 510000

Actively Recruiting

5

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China, 1540000

Actively Recruiting

6

Tumour Hospital of Anyang city

Anyang, Henan, China, 455000

Actively Recruiting

7

The First Affiliated Hospital of Henan University of Science & Technology

Luoyang, Henan, China, 471003

Actively Recruiting

8

Nanyang Central Hospital

Nanyang, Henan, China, 422000

Actively Recruiting

9

The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, China, 453100

Actively Recruiting

10

Henan Cancer Hospital

Zhengzhou, Henan, China, 450003

Actively Recruiting

11

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China, 450052

Actively Recruiting

12

Tongji Hospital, affiliated with Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China, 430030

Actively Recruiting

13

Hubei Cancer Hospital

Wuhan, Hubei, China, 430079

Not Yet Recruiting

14

Nantong Tumor Hospital

Nantong, Jiangsu, China, 226300

Actively Recruiting

15

Jiangyin People's Hospital

Wuxi, Jiangsu, China, 214400

Actively Recruiting

16

Jiangxi Provincial Tumor Hospital

Nanchang, Jiangxi, China, 330038

Not Yet Recruiting

17

Liaoning Cancer Hospital

Shenyang, Liaoning, China, 110000

Actively Recruiting

18

The First Hospital of China Medical University

Shenyang, Liaoning, China, 110002

Actively Recruiting

19

Affiliated Hospital of Jining Medical University

Jining, Shandong, China, 272000

Not Yet Recruiting

20

Sichuan Cancer Hospital&Institude, Sichuan Cancer Center,Affiliate Cancer Hospital Of University Of Electronic Science and Technology of China

Chengdu, Sichuan, China, 610041

Actively Recruiting

21

The Affiliated Cancer Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China, 830011

Actively Recruiting

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Research Team

Y

Yun Sun

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

4

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HS-20093 in Patients with Advanced Esophageal Carcinoma and Other Advanced Solid Tumors | DecenTrialz