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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Gastric Cancer (GC) Gastroesophageal Junction Cancer (GEJ)
• Intervention / Treatment: Drug: HLX07+HLX10+oxaliplatin+capecitabine; Drug: HLX07

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Dazhi Xu, MD; Phone Number: 021-64175590; Email: xudzh@shca.org.cn

Study Locations

• China
  • Shanghai, China, 200000
    • Recruiting
    • Fudan University Shanghai Cancer Center
    • Contact: Dazhi Xu, MD; Phone Number: 021-64175590; Email: xudzh@shca.org.cn
  • Gansu
    • Wuwei, Gansu, China, 730000
      • Recruiting
      • Gansu Wuwei Tumor Hospital
      • Contact: Peng Nie, MD; Phone Number: 0935-2268166; Email: nie.peng2008@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 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;
2. Age ≥ 18 years and ≤ 75 years when ICF is signed;
3. Unresectable locally advanced, or metastatic gastric cancer including gastroesophageal junction cancer, and histopathologically confirmed diagnosis of adenocarcinoma;
4. 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);
5. Measurable lesion according to RECIST v1.1 by IRRC;
6. ECOG score 0-1;
7. Expected survival 12 weeks.

Exclusion Criteria:

1. Has other active malignancies within 5 years before the first administration of the study drug;
2. Plan to or have previously received organ or bone marrow transplantation;
3. Uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage;
4. 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;
5. Have received any research drugs within 14 days before the first use of the study drugs.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shanghai Henlius Biotech

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2022
• Primary Completion (Anticipated): December 20, 2023
• Study Completion (Anticipated): March 30, 2024

Study Registration Dates

• First Submitted: February 16, 2022
• First Submitted That Met QC Criteria: February 16, 2022
• First Posted (Actual): February 18, 2022

Study Record Updates

• Last Update Posted (Actual): May 2, 2022
• Last Update Submitted That Met QC Criteria: April 25, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Capecitabine; Oxaliplatin
• Other Study ID Numbers: HLX07-GC201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No