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

Recruitment & Eligibility

Status: RECRUITING

Sex: All

Target Recruitment: 148

Inclusion Criteria

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；
The age of signing the informed consent is 18 -70 years, regardless of gender；
Provide archived or fresh tumor tissue for vendor test;
At least one measurable lesion according to RECIST v1.1 criteria；
Subjects with pathology confirmed locally advanced unresectable or metastatic esophageal squamous cell carcinoma;
The ECOG score is 0 or 1；
Expected survival ≥12 weeks
Good level of organ function
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

Inadequately treated central nervous system metastases or the presence of uncontrolled or symptomatic active central nervous system metastases；
Patients with uncontrolled tumor-related pain as determined by the investigator.
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
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
Have antitumor therapy was received 4 weeks before the start of the study；
Have previously received antiboy-coupled drugs containing topoisomerase I inhibitors
Systemic antitumor therapy was received 4 weeks before the start of the study
Treatment with CYP3A4, CYP2D6, P-gp, or BCRP booster or inducer is less than 5 drug half-lives from the date of first administration
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;
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
Toxicity and/or complications of previous antitumor therapy did not return to NCI-CTCAE level ≤1 or exclusion criteria
Live attenuated vaccines were used within 28 days prior to initial study administration or during the expected study treatment；
Systemic immunosuppressive therapy was administered within 14 days prior to the first study
Subjects with known or suspected interstitial pneumonia;
In the first study, a single blood loss ≥50ml or a cumulative daily blood loss ≥300m occurred within 1 month before medication
Subjects with severe cardiovascular and cerebrovascular disease;
Arterial/venous thrombosis events, such as deep vein thrombosis and pulmonary embolism, occurred within 3 months prior to initial administration
Had been diagnosed with any other malignancy
Subjects who had a severe infection within 28 days prior to the first dose
Active hepatitis B or active hepatitis C
Patients with active pulmonary tuberculosis within 1 year prior to enrolment
History of immune deficiency
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
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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment group A/B	SHR-A2102；Adebrelimab；Cisplatin	A：SHR-A2102+Adebrelimab B：SHR-A2102+Adebrelimab+Cisplatin

Primary Outcome Measures

Name	Time	Method
RP2D	through phase IB completion, an average of 1 years	RP2D will be determined on the basis of evaluation on safety, PK, efficacy data in Phase IB stages；
Incidence and severity of AE(DLT)：	from Day1 to 90 days after last dose	According to NCI-CTCAE v5.0 evaluation criteria from Day 1 to 90 days after last dose；
ORR：	18 months after the last subject was enrolled in the group	efficacy was assessed every 6 weeks within 48 weeks and every 9 weeks after 48 weeks s as determined by RECIST1.1

Secondary Outcome Measures

Name	Time	Method
OS(Investigator evaluation)	18 months after the last subject was enrolled in the group	Since C1D1 and death from any cause；
PFS(Investigator evaluation)	18 months after the last subject was enrolled in the group	Since C1D1 every 6 weeks within 48 weeks and every 9 weeks after 48 weeks, and the proportion of subjects whose best response was PR or CR or SD as determined by RECIST1.1；
DCR	18 months after the last subject was enrolled in the group	Since C1D1 every 6 weeks within 48 weeks and every 9 weeks after 48 weeks, and the proportion of subjects whose best response was PR or CR or SD as determined by RECIST1.1；
DOR	18 months after the last subject was enrolled in the group	Since C1D1 every 6 weeks within 48 weeks and every 9 weeks after 48 weeks, and the proportion of subjects whose best response was PR or CR or SD as determined by RECIST1.1；

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

Recruitment & Eligibility

Study & Design

Trial Locations

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