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

NCT07621601 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: HS-20093-310
• Study Type: interventional
• Target: 494
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Esophageal Squamous Cell Carcinoma (ESCC)

Keywords

ESCC; HS-20093; advanced; metastatic

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS)

  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 Outcomes (6)

• Progression-free survival (PFS) assessed by investigator

  Approximately 3 years after the first patient with first dose

• Objective response rate (ORR)

  Approximately 2 years after the first patient with first dose

• Disease control rate (DCR)

  Approximately 2 years after the first patient with first dose

• Duration of response (DoR)

  Approximately 3 years after the first patient with first dose

• Incidence and severity of AEs

  From the first dose until 90 days after the last dose

Study Arms (2)

HS-20093 for injection

EXPERIMENTAL

Drug: HS-20093 for Injection

Investigator's choice of monochemotherapy

ACTIVE COMPARATOR

Investigator should choose one of the monochemotherapy (irinotecan, paclitaxel, or docetaxel)

Drug: Irinotecan; Paclitaxel; Docetaxel

Interventions

HS-20093 for Injection DRUG

The patient will receive treatment with HS-20093.

Also known as: Risvutatug Rezetecan for injection, GSK5764227

HS-20093 for injection

Irinotecan; Paclitaxel; Docetaxel DRUG

The patient will receive treatment with Irinotecan or Paclitaxel or Docetaxel

Investigator's choice of monochemotherapy

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years at the time of informed consent form (ICF) signature, either sex.
• 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.
• Patients with histologically or cytologically confirmed diagnosis of advanced recurrent or metastatic esophageal squamous cell carcinoma (ESCC), progressed after receiving first-line standard treatment.
• Presence of at least one target lesion according to RECIST v1.1.
• Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 to 1.
• Minimum life expectancy \>12 weeks.
• Adequate organ function.
• Absence of the following active infectious diseases: hepatitis B, hepatitis C, human immunodeficiency virus (HIV) infection, tuberculosis, or syphilis.
• Female patients with negative serum pregnancy test result within 7 days prior to first dose administration, or documentation of no pregnancy risk.

You may not qualify if:

• \. 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:
• Prior or current treatment targeting B7-H3;
• 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.
• \. 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.
• \. Known or suspected interstitial pneumonitis, immune-mediated pneumonitis, or radiation pneumonitis.
• \. Known to have allergic reactions or contraindications to the investigational medicinal product.

Sponsors & Collaborators

• Hansoh BioMedical R&D Company: lead

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma; Neoplasm Metastasis

Interventions

Injections; Irinotecan; Paclitaxel; Docetaxel

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Camptothecin; Alkaloids; Heterocyclic Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2026
• First Posted: June 2, 2026
• Study Start (Estimated): July 31, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2032
• Last Updated: June 2, 2026

Record last verified: 2026-05