Study of HLX22 in Combanition With Trastuzumab and Chemotherapy Versus Placebo in Combination With Trastuzumab and Chemotherapy for Treatment of Locally Advanced or Metastatic Gastric Cancer

A Randomized, Double-blinded，Multicenter，Phase II Clinical Study of HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) in Combination With Trastuzumab and Chemotherapy (XELOX) Versus Placebo in Combination With Trastuzumab and Chemotherapy (XELOX) for Treatment of Locally Advanced or Metastatic Gastric Cancer (GC)

The purpose of this study is to evaluate the clinical efficacy and safety of HLX22 in the HER2+ Locally Adanved or Metastatic Gastric Cancer as the first-line therapy.This study consists of three periods, screening period (28 days), treatment period and follow-up period (including safety follow-up, survival follow-up).Subjects can be enrolled into this study only if they meet inclusion criteria and do not meet exclusion criteria. The enrolled subjects will receive an intravenous infusion of HLX22/placebo and SOC(standard of care: Trastuzumab + XELOX) once every 3 weeks until the loss of clinical benefit, death, intolerable toxicity, withdrawal of informed consent or other reasons as specified in the protocol(whichever occurs earlier).

Study Overview

• Status: Active, not recruiting
• Conditions: Gastric Cancer
• Intervention / Treatment: Drug: HLX22; Drug: Trastuzumab; Drug: Oxaliplatin; Drug: Capecitabine; Drug: Placebo

Detailed Description

HLX22(25mg/kg) or HLX22(15mg/kg) or placebo will be administered intravenously [IV] on day 1 of each 3-week cycle. Trastuzumab (8 mg/kg loading dose, 6 mg/kg maintenance dose) will be administered IV on day 1 of each 3-week cycle. SOC chemotherapy is XELOX (1000 mg/m^2 capecitabine administered orally twice daily [BID] on days 1-14 of each 3-week cycle and 130 mg/m^2 oxaliplatin administered IV on Day 1 of each 3-week cycle).

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Shanghai East Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Histologically or cytologically confirmed diagnosis of previously untreated, locally advanced unresectable or metastatic HER2 positive gastric adenocarcinoma.
• HER2-positive defined as either immunohistochemistry (IHC) 3+ or IHC 2+ in combination with in-situ hybridization positive (ISH+) or fluorescent in-situ hybridization (FISH), as assessed by central review on primary or metastatic tumor
• Has measurable disease as defined by RECIST 1.1 as determined by the IRRC
• Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
• Has a life expectancy of greater than 6 months
• Has adequate organ function

Exclusion Criteria:

• Has a known additional malignancy that is progressing or has required active treatment within the past 2 years
• Has history of HER2 targeted therapy
• Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate, in the opinion of the treating investigator
• Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 7 months after the last dose of trial treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HLX22(25mg/kg)+Trastuzumab + Chemotherapy (XELOX); Participants receive 25mg/kg HLX22 IV every 3 weeks (Q3W) plus trastuzumab (8 mg/kg loading dose, 6 mg/kg maintenance thereafter) IV Q3W in combination with XELOX chemotherapy	Drug: HLX22; IV Q3W D1; Drug: Trastuzumab; IV Q3W D1; Drug: Oxaliplatin; IV Q3W D1; Drug: Capecitabine; PO Q3W D1-D14
Experimental: HLX22(15mg/kg)+Trastuzumab + Chemotherapy (XELOX); Participants receive 15mg/kg HLX22 IV Q3W plus trastuzumab (8 mg/kg loading dose, 6 mg/kg maintenance thereafter) IV Q3W in combination with XELOX chemotherapy	Drug: HLX22; IV Q3W D1; Drug: Trastuzumab; IV Q3W D1; Drug: Oxaliplatin; IV Q3W D1; Drug: Capecitabine; PO Q3W D1-D14
Active Comparator: Placebo +Trastuzumab + Chemotherapy (XELOX); Participants receive placebo IV Q3W plus trastuzumab (8 mg/kg loading dose, 6 mg/kg maintenance thereafter) IV Q3W in combination with XELOX chemotherapy	Drug: Trastuzumab; IV Q3W D1; Drug: Oxaliplatin; IV Q3W D1; Drug: Capecitabine; PO Q3W D1-D14; Drug: Placebo; IV Q3W D1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival (PFS) per RECIST 1.1 assessed by IRRC(Independent Radiology Review Committee)	PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 as assessed by IRRC or death due to any cause, whichever occurs first. PFS will be determined for each treatment arm	Up to 5 years
Objective Response Rate (ORR) per RECIST 1.1 assessed by IRRC	ORR is defined as the percentage of participants who have a Complete Response ([CR], disappearance of all evidence of disease) or Partial Response ([PR], regression of measurable disease and no new sites) per RECIST 1.1 as assessed by IRRC. ORR will be determined for each treatment arm.	Up to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	OS is defined as the time from randomization to death due to any cause. OS will be determined for each treatment arm.	Up to 5 years
Duration of Response (DOR) per RECIST 1.1 assessed by IRRC	For participants who demonstrate CR or PR, DOR is defined as the time from first response (CR or PR) to subsequent disease progression or death from any cause, whichever occurs first. DOR will be determined for each treatment arm	Up to 5 years
Adverse Events (AE)	An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of participants who experience an AE will be reported for each treatment arm.	Up to 5 years

Collaborators and Investigators

• Sponsor: Shanghai Henlius Biotech

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2021
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: May 21, 2021
• First Submitted That Met QC Criteria: May 27, 2021
• First Posted (Actual): June 1, 2021

Study Record Updates

• Last Update Posted (Estimated): April 15, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

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; Antineoplastic Agents, Immunological; Trastuzumab; Capecitabine; Oxaliplatin
• Other Study ID Numbers: HLX22-GC-201

Drug and device information, study documents

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