A Study of HS-20093 in Patients With Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC)
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorHansoh BioMedical R&D Company
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- HS-20093 for Injection
- Irinotecan; Paclitaxel; Docetaxel
Treatment groups
494 Participants
are divided into 2 treatment groupsLocations
This trial has no locations
Sponsors and collaborators
Hansoh BioMedical R&D Company
Lead sponsor
Source ClinicalTrials.gov