A Study of HS-20093 in Patients With Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC)

May 26, 2026 updated by: Hansoh BioMedical R&D Company

A Multicenter, Randomized, Open-Label, Controlled Phase III Clinical Study Evaluating the Efficacy and Safety of HS-20093- Injection Versus Investigator's Choice of Chemotherapy in Patients With Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma After Progress of First-Line Standard Therapy

This is a multicenter, randomized, open-label, controlled phase III clinical study to evaluate the efficacy and safety of HS-20093- injection versus investigator's choice of chemotherapy in patients with locally advanced or metastatic esophageal squamous cell carcinoma after progress of first-line standard therapy.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a multicenter, randomized, open-label, controlled phase III clinical study to evaluate the efficacy and safety of HS-20093- injection versus investigator's choice of chemotherapy in patients with locally advanced or metastatic esophageal squamous cell carcinoma after progress of first-line standard therapy.

Eligible participants will be randomly assigned in a 1:1 ratio to the experimental arm (HS-20093) or the control arm (investigator's choice of monochemotherapy, including irinotecan, paclitaxel, or docetaxel). Both experimental arm and control arm will receive a treatment cycle of 21 days until disease progression or other treatment discontinuation criteria are met; Efficacy and safety will be analyzed and evaluated in both arms following the protocol-specified follow-up procedure.

Study Type

Interventional

Enrollment (Estimated)

494

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥18 years at the time of informed consent form (ICF) signature, either sex.
  2. Be willing to participate in this clinical trial with understanding of study procedures, ability to provide written informed consent, and commitment to comply with all requirements specified in this clinical trial protocol.
  3. Patients with histologically or cytologically confirmed diagnosis of advanced recurrent or metastatic esophageal squamous cell carcinoma (ESCC), progressed after receiving first-line standard treatment.
  4. Presence of at least one target lesion according to RECIST v1.1.
  5. Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 to 1.
  6. Minimum life expectancy >12 weeks.
  7. Adequate organ function.
  8. Absence of the following active infectious diseases: hepatitis B, hepatitis C, human immunodeficiency virus (HIV) infection, tuberculosis, or syphilis.
  9. Female patients with negative serum pregnancy test result within 7 days prior to first dose administration, or documentation of no pregnancy risk.

Exclusion Criteria:

  • 1. Prior pathological diagnosis of esophageal adenocarcinoma, esophageal adenoid cystic carcinoma, esophageal mucoepidermoid carcinoma, esophageal undifferentiated carcinoma, esophageal neuroendocrine carcinoma, or esophageal mixed carcinoma 2. Prior or ongoing treatment with any of the following:

    1. Prior or current treatment targeting B7-H3;

    2. Prior or current treatment with topoisomerase I inhibitor agents, including antibody-drug conjugates with topoisomerase I inhibitor payloads, etc.; 3. Persistent adverse reactions caused by prior treatment. 4. Untreated brain metastases; uncontrolled brain metastases; presence of leptomeningeal or brainstem metastases; presence of spinal cord compression.

      5. History of other primary malignancies. 6. Severe, uncontrolled, or active cardiovascular or cerebrovascular disease. 7. Severe or poorly controlled hypertension and diabetes mellitus. 8. Tumors have the risk of leading perforation/fistula, hemorrhage, or obstruction.

      9. Known or suspected interstitial pneumonitis, immune-mediated pneumonitis, or radiation pneumonitis.

      10. Known to have allergic reactions or contraindications to the investigational medicinal product.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HS-20093 for injection
Drug: HS-20093 for Injection
The patient will receive treatment with HS-20093.
Other Names:
  • GSK5764227
  • Risvutatug Rezetecan for injection
Active Comparator: Investigator's choice of monochemotherapy
Investigator should choose one of the monochemotherapy (irinotecan, paclitaxel, or docetaxel)
Drug: Irinotecan; Paclitaxel; Docetaxel
The patient will receive treatment with Irinotecan or Paclitaxel or Docetaxel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: Approximately 4 years after the first patient with first dose
Overall Survival is defined as the time from the date of randomization to the date of participant's death due to any cause
Approximately 4 years after the first patient with first dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence and severity of AEs
Time Frame: From the first dose until 90 days after the last dose
From the first dose until 90 days after the last dose
Incidence and severity of SAEs
Time Frame: From the first dose until 90 days after the last dose
From the first dose until 90 days after the last dose
Progression-free survival (PFS) assessed by investigator
Time Frame: Approximately 3 years after the first patient with first dose
PFS assessed by investigator per RECIST v1.1
Approximately 3 years after the first patient with first dose
Objective response rate (ORR)
Time Frame: Approximately 2 years after the first patient with first dose
ORR assessed by investigator per RECIST v1.1
Approximately 2 years after the first patient with first dose
Disease control rate (DCR)
Time Frame: Approximately 2 years after the first patient with first dose
DCR assessed by investigator per RECIST v1.1
Approximately 2 years after the first patient with first dose
Duration of response (DoR)
Time Frame: Approximately 3 years after the first patient with first dose
DoR assessed by investigator per RECIST v1.1
Approximately 3 years after the first patient with first dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hansoh BioMedical R&D Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 31, 2026

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2032

Study Registration Dates

First Submitted

May 26, 2026

First Submitted That Met QC Criteria

May 26, 2026

First Posted (Actual)

June 2, 2026

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

May 26, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS-20093-310

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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