Study of HLX10, Trastuzumab and Chemotherapy in First-line Treatment of HER2-positive Recurrent/Metastatic Gastric Cancer

Investigators assessed the effectiveness of HLX10, Trastuzumab and Chemotherapy in First-line Treatment of HER2-positive Recurrent/Metastatic Gastric Cancer

Study Overview

• Status: Not yet recruiting
• Conditions: HER2-positive Gastric Cancer
• Intervention / Treatment: Drug: HLX10, Trastuzumab and Chemotherapy

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

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. Histologically or cytologically proven metastatic or locally advanced HER2-positive gastric cancer
2. Documented disease progression after receiving prior line of trastuzumab-containing chemotherapy for gastric cancer
3. Able and willing to give written informed consent and has signed the informed consent form (ICF), prior to performance of any trial activities.
4. Eligible male and female subjects aged ≥18 years.
5. Has measurable disease as determined by RECIST 1.1.
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
7. Has baseline left ventricular ejection fraction (LVEF) ≥ 55%.
8. Adequate organ function as demonstrated by laboratory test results within 14 days prior to first dose of study treatment.
9. Have urinary protein that is <2 on dipstick or routine urinalysis.
10. Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to first dose of study treatment.
11. Female subjects of childbearing potential and male subjects should be willing to use methods of birth control for the course of the study and up to 120 days after the last dose of study treatment.

Exclusion Criteria:

1. Received prior anticancer treatment with targeted agents, chemotherapy, or radiotherapy within 14 days, with monoclonal antibodies within 28 days, has previously received treatment with ramucirumab, or has participated in another clinical trial within 14 days prior to start of study treatment.
2. Has experienced any Grade 3-4 gastrointestinal bleeding within 3 months prior to treatment.
3. Has experienced any arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, within 3 months prior to treatment.
4. Has history of severe thromboembolism, including deep vein thrombosis and pulmonary embolism within 6 months prior to treatment.
5. Has an active or ongoing infection, symptomatic congestive heart failure, （6）uncontrolled angina pectoris, symptomatic or poorly controlled arrhythmia, uncontrolled thrombotic or hemorrhagic disorder, or any other serious uncontrolled medical disorders in the opinion of the investigator.

（7）Has ongoing or active psychiatric illness or social situation that would limit compliance with study requirements.

（8）Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.

（9）Has evidence of active, non-infectious pneumonitis. （10）Have an elective or a planned major surgery during the course of the trial or has undergone major surgery within 4 weeks prior to enrollment.

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

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HLX10, Trastuzumab and Chemotherapy; HLX10, Trastuzumab and Chemotherapy in First-line Treatment of HER2-positive Recurrent/Metastatic Gastric Cancer	Drug: HLX10, Trastuzumab and Chemotherapy; HLX10 4.5mg/kg, IV, q3weeks, Day 1 trastuzumab 6mg/kg (8mg loading dose), IV, q3weeks, Day 1 S1 40mg/m2, PO, BID, Day 1-14 oxaliplatin 100mg/m2, IV, q3weeks, Day 1 docetaxel 40mg/m2, IV, q3weeks, Day 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival	Progression-free survival in patients with HER2-positive gastric cancer receiving HLX10, trastuzumab, and chemotherapy combination treatment	18 months after start of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Overall survival	through study completion, an average of 2 years
Objective response rate according to RECIST 1.1	Objective response rate according to RECIST 1.1	through study completion, an average of 2 years
Safety and tolerability based on incidence of treatment-emergent adverse events as assessed by CTCAE	Safety and tolerability based on incidence of treatment-emergent adverse events as assessed by CTCAE	Throughout the overall study period as well as up to 3 months after the last dose study treatment for each subject

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): April 15, 2022
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: March 23, 2022
• First Submitted That Met QC Criteria: March 28, 2022
• First Posted (Actual): April 5, 2022

Study Record Updates

• Last Update Posted (Actual): April 5, 2022
• Last Update Submitted That Met QC Criteria: March 28, 2022
• Last Verified: March 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; Antineoplastic Agents; Antineoplastic Agents, Immunological; Trastuzumab
• Other Study ID Numbers: HLX10GCIIT01

Drug and device information, study documents

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