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

Last updated: January 2, 2025
Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Digestive System Neoplasms

Esophageal Disorders

Treatment

SHR-A2102;Adebrelimab;Cisplatin

Clinical Study ID

NCT06474468
SHR-A2102-203
  • Ages 18-70
  • All Genders

Study 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

Inclusion Criteria:

  1. Have the ability to give informed consent, have signed informed and able to complywith 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 metastaticesophageal 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 whoare fertile are required to use highly effective contraceptive methods.

Exclusion

Exclusion Criteria:

  1. Inadequately treated central nervous system metastases or the presence ofuncontrolled or symptomatic active central nervous system metastases;

  2. Patients with uncontrolled tumor-related pain as determined by the investigator.

  3. Moderate or severe ascites with clinical symptoms (i.e., those who requiredtherapeutic puncture or drainage within 2 weeks before the study treatment, and onlythose who showed a small amount of ascites without clinical symptoms could beincluded in the study); Unable to control or moderate or higher amounts of pleuraleffusion or pericardial effusion

  4. A history of gastrointestinal perforation and/or fistula within 6 months prior toinitial medication, or significant tumor invasion of adjacent organs (large arteriesor trachea, etc.), resulting in a higher risk of bleeding or fistula

  5. Have antitumor therapy was received 4 weeks before the start of the study;

  6. Have previously received antiboy-coupled drugs containing topoisomerase I inhibitors

  7. Systemic antitumor therapy was received 4 weeks before the start of the study

  8. Treatment with CYP3A4, CYP2D6, P-gp, or BCRP booster or inducer is less than 5 drughalf-lives from the date of first administration

  9. Surgical procedures requiring tracheal intubation and general anesthesia wereperformed within 28 days prior to the initial study, diagnostic or superficialsurgery was performed within 7 days prior to the initial study, or elective surgerywas expected during the trial period;

  10. Perform non-chest radiation therapy with >30Gy within 28 days before dosing, chestradiation therapy with >30Gy within 24 weeks before first dosing, and radiationtherapy with ≤30Gy within 14 days before first dosing

  11. Toxicity and/or complications of previous antitumor therapy did not return toNCI-CTCAE level ≤1 or exclusion criteria

  12. Live attenuated vaccines were used within 28 days prior to initial studyadministration or during the expected study treatment;

  13. Systemic immunosuppressive therapy was administered within 14 days prior to thefirst study

  14. Subjects with known or suspected interstitial pneumonia;

  15. In the first study, a single blood loss ≥50ml or a cumulative daily blood loss ≥300moccurred within 1 month before medication

  16. Subjects with severe cardiovascular and cerebrovascular disease;

  17. Arterial/venous thrombosis events, such as deep vein thrombosis and pulmonaryembolism, occurred within 3 months prior to initial administration

  18. Had been diagnosed with any other malignancy

  19. Subjects who had a severe infection within 28 days prior to the first dose

  20. Active hepatitis B or active hepatitis C

  21. Patients with active pulmonary tuberculosis within 1 year prior to enrolment

  22. History of immune deficiency

  23. Severe allergic reactions are known to occur in individuals allergic to anycomponent of SHR-A2102, SHR-1316, or other monoclonal antibody/fusion protein drugs

  24. Per the investigator's judgment, there are any other circumstances that may increasethe risk of participating in the study, interfere with the study results, or makeparticipation in the study inappropriate.

Study Design

Total Participants: 148
Treatment Group(s): 1
Primary Treatment: SHR-A2102;Adebrelimab;Cisplatin
Phase: 1/2
Study Start date:
June 20, 2024
Estimated Completion Date:
October 31, 2026

Connect with a study center

  • Affiliated Cancer Hospital of Shandong First Medical University

    Jinan, Shandong 250117
    China

    Active - Recruiting

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