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

NCT06112704 | Recruiting Phase 2

• 1 other identifier: HS-20093-203
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 21

Brief 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.

Conditions

Advanced Solid Tumor

Keywords

Advanced solid tumor; Esophageal Carcinoma; B7-H3; antibody-drug conjugate (ADC); HS-20093

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• DOR assessed by RECIST 1.1 criteria

  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

  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

  From the first dose up to PD or death，whichever came first, assessed up to 24 months.

• Overall survival (OS)

  From the first dose up to PD or death，whichever came first, assessed up to 24 months.

• Incidence and severity of adverse events

  From the first dose until 90 days after the last dose

Study Arms (4)

Phase IIa: Cohort 1

EXPERIMENTAL

Participants with advanced esophageal squamous cell carcinoma will be administered HS-20093.

Drug: HS-20093

Phase IIa: Cohort 2

EXPERIMENTAL

Participants with advanced esophageal adenocarcinoma and gastroesophageal junction adenocarcinoma will be administered HS-20093.

Drug: HS-20093

Phase IIa: Cohort 3

EXPERIMENTAL

Participants with other advanced solid tumor will be administered HS-20093.

Drug: HS-20093

Phase IIb

EXPERIMENTAL

Participants with advanced esophageal squamous cell carcinoma will be administered HS-20093.

Drug: HS-20093

Interventions

HS-20093 DRUG

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.

Phase IIa: Cohort 1; Phase IIa: Cohort 2; Phase IIa: Cohort 3; Phase IIb

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women aged more than or equal to (≥) 18 years.
• Histologically or cytologically confirmed, relapsed, locally advanced or metastatic esophageal carcinomas and other advanced solid tumor.
• At least one extra measurable lesion according to RECIST 1.1 (cavity structures such as oesophagus cannot serve as measurable lesions).
• Agree to provide fresh or archival tumor tissue and blood samples.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0\~1.
• Estimated life expectancy \>12 weeks.
• Agree to use medically accepted methods of contraception.
• Men or women should be using adequate contraceptive measures throughout the study.
• Females subjects must not be pregnant at screening or have evidence of non-childbearing potential.
• Signed and dated Informed Consent Form.

You may not qualify if:

• Any of the following would exclude the subject from participation in the study:
• 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
• Subjects with previous or concurrent malignancies
• Significant tumor invasion into adjacent organs (aorta or trachea) of esophageal lesions leading to higher risk of bleeding or fistula
• Inadequate bone marrow reserve or organ dysfunction.
• Evidence of cardiovascular risk
• Evidence of current severe or uncontrolled systemic diseases
• Evidence of mucosal or internal bleeding within 1 month prior to the first scheduled dose of HS-20093
• Severe infections occured within 4 weeks before the first dose
• The presence of active infectious diseases has been known before first dose such as hepatitis B, hepatitis C, ect
• History of neuropathy or mental disorders
• Pregnant or lactating female
• 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
• Known vaccination or hypersensitivity of any level within 4 weeks prior to the first scheduled dose of HS-20093

Sponsors & Collaborators

• Hansoh BioMedical R&D Company: lead

Study Sites (21)

Anhui Provincial Cancer Hospital

Hefei, Anhui, 230031, China

RECRUITING

Fujian Provincial Tumor Hospital

Fujian, Fujian, 350014, China

NOT YET RECRUITING

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

Fuzhou, Fujian, 350014, China

RECRUITING

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510000, China

RECRUITING

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 1540000, China

RECRUITING

Tumour Hospital of Anyang city

Anyang, Henan, 455000, China

RECRUITING

The First Affiliated Hospital of Henan University of Science & Technology

Luoyang, Henan, 471003, China

RECRUITING

Nanyang Central Hospital

Nanyang, Henan, 422000, China

RECRUITING

The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, 453100, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, 450003, China

RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

RECRUITING

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

Wuhan, Hubei, 430030, China

RECRUITING

Hubei Cancer Hospital

Wuhan, Hubei, 430079, China

NOT YET RECRUITING

Nantong Tumor Hospital

Nantong, Jiangsu, 226300, China

RECRUITING

Jiangyin People's Hospital

Wuxi, Jiangsu, 214400, China

RECRUITING

Jiangxi Provincial Tumor Hospital

Nanchang, Jiangxi, 330038, China

NOT YET RECRUITING

Liaoning Cancer Hospital

Shenyang, Liaoning, 110000, China

RECRUITING

The First Hospital of China Medical University

Shenyang, Liaoning, 110002, China

RECRUITING

Affiliated Hospital of Jining Medical University

Jining, Shandong, 272000, China

NOT YET RECRUITING

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

Chengdu, Sichuan, 610041, China

RECRUITING

The Affiliated Cancer Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, 830011, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Central Study Contacts

Yun Sun

CONTACT

18321785381; suny20@hspharm.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2023
• First Posted: November 1, 2023
• Study Start: February 6, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 2, 2024

Record last verified: 2024-11

Locations

CN (21)