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

NCT ID: NCT06474468

Last Updated: 2025-01-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-20
• Study Completion Date: 2026-10-31

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

Conditions

Advanced or Metastatic Esophageal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment group A/B

A：SHR-A2102+Adebrelimab B：SHR-A2102+Adebrelimab+Cisplatin

Group Type: EXPERIMENTAL

SHR-A2102；Adebrelimab；Cisplatin

Intervention Type: DRUG

Drug: SHR-A2102 Administration by intravenous infusion for a cycle of 3 weeks.

Drug: Adebrelimab Administration by intravenous infusion for a cycle of 3 weeks.

Drug: Cisplatin Administration by intravenous infusion for a cycle of 3 weeks.

Interventions

SHR-A2102；Adebrelimab；Cisplatin

Drug: SHR-A2102 Administration by intravenous infusion for a cycle of 3 weeks.

Drug: Adebrelimab Administration by intravenous infusion for a cycle of 3 weeks.

Drug: Cisplatin Administration by intravenous infusion for a cycle of 3 weeks.

Intervention Type: DRUG

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 investigator.

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

4. A history of gastrointestinal perforation and/or fistula within 6 months prior to initial medication, or significant tumor invasion of adjacent organs (large arteries or 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 drug half-lives from the date of first administration

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

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

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

13. Systemic immunosuppressive therapy was administered within 14 days prior to the first 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 ≥300m occurred within 1 month before medication

16. Subjects with severe cardiovascular and cerebrovascular disease;

17. Arterial/venous thrombosis events, such as deep vein thrombosis and pulmonary embolism, 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 any component 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 increase the risk of participating in the study, interfere with the study results, or make participation in the study inappropriate.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Hengrui Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Affiliated Cancer Hospital of Shandong First Medical University

Jinan, Shandong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zongyan Xie

Role: CONTACT

zongyan.xie.zx3@hengrui.com

0518-82342973

Other Identifiers

SHR-A2102-203

Identifier Type: -

Identifier Source: org_study_id