A Trial of SHR-A2102 With Adebrelimab With or Without Other Antitumor Therapy in Advanced or Metastatic Esophageal Cancer
A Phase IB /II, Multicenter, Open-Label Study of Safety, Tolerability and Efficacy of SHR-A2102 for Injection With Adebrelimab With or Without Other Antitumor Therapy in Advanced or Metastatic Esophageal Cancer
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
Study Contact
- Name: Zongyan Xie
- Phone Number: 0518-82342973
- Email: zongyan.xie.zx3@hengrui.com
Study Locations
-
-
Shandong
-
Jinan, Shandong, China, 250117
- Recruiting
- Affiliated Cancer Hospital of Shandong First Medical University
-
Principal Investigator:
- Jinming Yu
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Treatment group A/B
A:SHR-A2102+Adebrelimab B: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. |
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
RP2D
Time Frame: 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;
|
through phase IB completion, an average of 1 years
|
|
Incidence and severity of AE(DLT):
Time Frame: 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;
|
from Day1 to 90 days after last dose
|
|
ORR:
Time Frame: 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
|
18 months after the last subject was enrolled in the group
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
DCR
Time Frame: 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;
|
18 months after the last subject was enrolled in the group
|
|
DOR
Time Frame: 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;
|
18 months after the last subject was enrolled in the group
|
|
PFS(Investigator evaluation)
Time Frame: 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;
|
18 months after the last subject was enrolled in the group
|
|
OS(Investigator evaluation)
Time Frame: 18 months after the last subject was enrolled in the group
|
Since C1D1 and death from any cause;
|
18 months after the last subject was enrolled in the group
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- SHR-A2102-203
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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