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Recruiting Phase 1, Phase 2 NCT06474468

A Trial of SHR-A2102 With Adebrelimab With or Without Other Antitumor Therapy in Advanced or Metastatic Esophageal Cancer

Trial Parameters

Condition Advanced or Metastatic Esophageal Cancer
Sponsor Shanghai Hengrui Pharmaceutical Co., Ltd.
Study Type INTERVENTIONAL
Phase Phase 1, Phase 2
Enrollment 148
Sex ALL
Min Age 18 Years
Max Age 70 Years
Start Date 2024-06-20
Completion 2026-10
Interventions
SHR-A2102;Adebrelimab;Cisplatin

Brief Summary

The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-A2102 with Adebrelimab with or without other Antitumor Therapy in Advanced or Metastatic Esophageal Cancer. To explore the reasonable dosage of SHR-A2102 for Advanced or Metastatic Esophageal Cancer

Eligibility Criteria

Inclusion Criteria: 1. Have the ability to give informed consent, have signed informed and able to comply with the treatment plan to visit the tests and other procedural requirements; 2. The age of signing the informed consent is 18 -70 years, regardless of gender; 3. Provide archived or fresh tumor tissue for vendor test; 4. At least one measurable lesion according to RECIST v1.1 criteria; 5. Subjects with pathology confirmed locally advanced unresectable or metastatic esophageal squamous cell carcinoma; 6. The ECOG score is 0 or 1; 7. Expected survival ≥12 weeks 8. Good level of organ function 9. Male subjects whose partners are women of childbearing age and female subjects who are fertile are required to use highly effective contraceptive methods. Exclusion Criteria: 1. Inadequately treated central nervous system metastases or the presence of uncontrolled or symptomatic active central nervous system metastases; 2. Patients with uncontrolled tumor-related pain as determined by the in

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