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

A Phase 2, Open-label, Multi-center Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of HS-20093 in Patients with Advanced Esophageal Carcinoma and Other Advanced Solid Tumors (ARTEMIS-005)

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumor
• Intervention / Treatment: Drug: HS-20093

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.

• Study Type: Interventional
• Enrollment (Estimated): 220
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Yun Sun; Phone Number: 18321785381; Email: suny20@hspharm.com

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230031
      • Recruiting
      • Anhui Provincial Cancer Hospital
  • Fujian
    • Fujian, Fujian, China, 350014
      • Not yet recruiting
      • Fujian Provincial Tumor Hospital
    • Fuzhou, Fujian, China, 350014
      • Recruiting
      • The 900th Hospital of the Joint Service Support Force of the Chinese People's Liberation Army
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • Guangdong Provincial People's Hospital
  • Heilongjiang
    • Harbin, Heilongjiang, China, 1540000
      • Recruiting
      • Harbin Medical University Cancer Hospital
  • Henan
    • Anyang, Henan, China, 455000
      • Recruiting
      • Tumour Hospital of Anyang city
    • Luoyang, Henan, China, 471003
      • Recruiting
      • The First Affiliated Hospital of Henan University of Science & Technology
    • Nanyang, Henan, China, 422000
      • Recruiting
      • Nanyang Central Hospital
    • Xinxiang, Henan, China, 453100
      • Recruiting
      • The First Affiliated Hospital of Xinxiang Medical University
    • Zhengzhou, Henan, China, 450003
      • Recruiting
      • Henan Cancer Hospital
    • Zhengzhou, Henan, China, 450052
      • Recruiting
      • The First Affiliated Hospital of Zhengzhou University
  • Hubei
    • Wuhan, Hubei, China, 430079
      • Not yet recruiting
      • Hubei Cancer Hospital
    • Wuhan, Hubei, China, 430030
      • Recruiting
      • Tongji Hospital, affiliated with Tongji Medical College, Huazhong University of Science and Technology
  • Jiangsu
    • Nantong, Jiangsu, China, 226300
      • Recruiting
      • Nantong Tumor Hospital
    • Wuxi, Jiangsu, China, 214400
      • Recruiting
      • Jiangyin People'S Hospital
  • Jiangxi
    • Nanchang, Jiangxi, China, 330038
      • Not yet recruiting
      • Jiangxi Provincial Tumor Hospital
  • Liaoning
    • Shenyang, Liaoning, China, 110000
      • Recruiting
      • Liaoning Cancer Hospital
    • Shenyang, Liaoning, China, 110002
      • Recruiting
      • The First Hospital of China Medical University
  • Shandong
    • Jining, Shandong, China, 272000
      • Not yet recruiting
      • Affiliated Hospital of Jining Medical University
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Recruiting
      • Sichuan Cancer Hospital&Institude, Sichuan Cancer Center,Affiliate Cancer Hospital Of University Of Electronic Science and Technology of China
  • Xinjiang
    • Ürümqi, Xinjiang, China, 830011
      • Recruiting
      • The Affiliated Cancer Hospital of Xinjiang Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phase IIa: Cohort 1; Participants with advanced esophageal squamous cell carcinoma will be administered HS-20093.	Drug: HS-20093; 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.
Experimental: Phase IIa: Cohort 2; Participants with advanced esophageal adenocarcinoma and gastroesophageal junction adenocarcinoma will be administered HS-20093.	Drug: HS-20093; 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.
Experimental: Phase IIa: Cohort 3; Participants with other advanced solid tumor will be administered HS-20093.	Drug: HS-20093; 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.
Experimental: Phase IIb; Participants with advanced esophageal squamous cell carcinoma will be administered HS-20093.	Drug: HS-20093; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate (ORR) determined by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.	ORR was defined as the percentage of participants who achieved a best overall response (BOR) of confirmed Complete Response (CR) or Partial Response (PR), assessed by investigators based on RECIST version 1.1[Confirmed CR/PR assessment require at least one repeat (≥4 weeks)].	From the first dose up to disease progression（PD）or withdrawal from study，whichever comes first，assessed up to 24 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DOR assessed by RECIST 1.1 criteria	DOR was defined as the period from the first occurrence of CR or PR to PD or death from any cause. If no PD or death after CR/PR, the cut-off date of progression-free survival (PFS) would be used [Confirmed CR/PR assessment require at least one repeat (≥4 weeks)	From the first dose up to PD or death, whichever came first, assessed up to 24 months.
Disease Control Rate (DCR) assessed by RECIST 1.1 criteria	DCR was evaluated by the number of participants with best overall response of CR, PR and stable disease (SD) [Confirmed CR/PR assessment require at least one repeat (≥4 weeks); SD shall be assessed at least 5 weeks after the first dose.	From the first dose up to PD or withdrawal from study, whichever came first, assessed up to 24 months.
PFS assessed by RECIST 1.1 criteria	PFS was defined as the time from first dose or random assignment (if any) to PD or death from any cause	From the first dose up to PD or death，whichever came first, assessed up to 24 months.
Overall survival (OS)	OS was defined as the time from the first dose or random assignment (if any) to death from any cause	From the first dose up to PD or death，whichever came first, assessed up to 24 months.
Incidence and severity of adverse events	AE assessed by investigator exclusively related to subject's underlying disease or medical condition [graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0]. Any untoward medical occurrence in a clinical study participant, whether or not considered related to the medicinal product. Incidence and severity of AEs are assessed according to vital signs, laboratory variables, physical examination, electrocardiogram, etc	From the first dose until 90 days after the last dose
Characterize the pharmacokinetic parameters of HS-20093	Characterize the pharmacokinetic parameters of HS-20093	Cycle 1 Day 1 up to 90 days after the last dose
Assess the incidence of anti-drug antibodies (ADAs)	Serum samples were collected for the determination of anti-drug antibody (ADA) at designated time points	Cycle 1 Day 1 up to 90 days after the last dose

Collaborators and Investigators

• Sponsor: Hansoh BioMedical R&D Company

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: October 29, 2023
• First Submitted That Met QC Criteria: October 29, 2023
• First Posted (Actual): November 1, 2023

Study Record Updates

• Last Update Posted (Estimated): December 2, 2024
• Last Update Submitted That Met QC Criteria: November 27, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Advanced solid tumor; Esophageal Carcinoma; B7-H3; antibody-drug conjugate (ADC); HS-20093
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Esophageal Diseases; Carcinoma; Esophageal Neoplasms
• Other Study ID Numbers: HS-20093-203

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No