HLX07+HLX10+Chemotherapy or HLX07 Monotherapy in Patients With Advanced Metastatic Gastric Cancer

Study Overview
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Brief Summary
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This study is conducted in patients with advanced metastatic gastric cancer including gastroesophageal junction cancer. This study includes two arms: A and B. Arm A (patients with HER2 negative and PD-L1 CPS≥5 ) will receive HLX07 combination therapy with HLX10 and chemotherapy (oxaliplatin+capecitabine) as first-line treatment. Arm B will receive HLX07 monotherapy as third-line or above treatment. All of eligible patients will receive study drug treatment until loss of clinical benefit, unacceptable toxicity, death, withdrawal of informed consent (whichever occurs first, HLX10 treatment up to 2 years).

Official Title
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An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 (Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) + HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) + Chemotherapy or HLX07 Monotherapy in Patients With Advanced Metastatic Gastric Cancer

Conditions
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Gastric Cancer (GC) Gastroesophageal Junction Cancer (GEJ)

Intervention / Treatment
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* Drug: HLX07+HLX10+oxaliplatin+capecitabine
* Drug: HLX07


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Volunteer to participate in this clinical study; completely understand and know this study as well as sign the informed consent form (ICF); be willing to follow and be able to complete all study procedures; Age ≥ 18 years and ≤ 75 years when ICF is signed; Unresectable locally advanced, or metastatic gastric cancer including gastroesophageal junction cancer, and histopathologically confirmed diagnosis of adenocarcinoma; Arm A: never received systemic anti-tumor drug therapy before, with HER2 negative and PD-L1 CPS≥5; Arm B: failed to prior systemic anti-tumor therapy (at least 2 lines); Measurable lesion according to RECIST v1.1 by IRRC; ECOG score 0-1; Expected survival 12 weeks. Exclusion Criteria: Has other active malignancies within 5 years before the first administration of the study drug; Plan to or have previously received organ or bone marrow transplantation; Uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage; Arm A: previously received antibody drugs against immune checkpoints (such as PD-1, PD-L1, CTLA4, etc.) and / or antibody drugs against EGFR; Arm B: previously received antibody drug treatment against EGFR; Have received any research drugs within 14 days before the first use of the study drugs.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br>HER2 negative and PD-L1 CPS≥5, as first-line therapy | Drug: HLX07+HLX10+oxaliplatin+capecitabine<br>* HLX07 1500mg+HLX10 300mg+oxaliplatin 130mg/m2+capecitabine 1000mg/m2 q3w<br>|
| Experimental: Arm B<br>As third-line or above therapy | Drug: HLX07<br>* HLX07 1500mg q3w<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR | Objective response rate by IRRC assessment per RECIST 1.1 | Up to 2 years | 
| PFS | Progression-free survival by IRRC assessment per RECIST 1.1 | From the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier), assessed up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OS | Overall survival | From the date of first dose unitl the date of death from any cause，assessed up to 2 years | 
| ORR | Objective response rate by INV assessment per RECIST 1.1 | Up to 2 years | 
| PFS | Objective response rate by INV assessment per RECIST 1.1 | From the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier), assessed up to 2 years | 
| DOR | Duration of response by IRRC/INV assessment per RECIST 1.1 | From the date when CR or PR (whichever recorded earlier) is firstly achieved until the date when disease progression or death is firstly recorded (whichever occurs earlier),assessed up to 2 years |