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

NCT04908813 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: HLX22-GC-201
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Overall Survival (OS)

  Up to 5 years

• Duration of Response (DOR) per RECIST 1.1 assessed by IRRC

  Up to 5 years

• Adverse Events (AE)

  Up to 5 years

Study Arms (3)

HLX22(25mg/kg)+Trastuzumab + Chemotherapy (XELOX)

EXPERIMENTAL

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; Drug: Trastuzumab; Drug: Oxaliplatin; Drug: Capecitabine

HLX22(15mg/kg)+Trastuzumab + Chemotherapy (XELOX)

EXPERIMENTAL

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; Drug: Trastuzumab; Drug: Oxaliplatin; Drug: Capecitabine

Placebo +Trastuzumab + Chemotherapy (XELOX)

ACTIVE COMPARATOR

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: Placebo; Drug: Trastuzumab; Drug: Oxaliplatin; Drug: Capecitabine

Interventions

HLX22 DRUG

IV Q3W D1

HLX22(15mg/kg)+Trastuzumab + Chemotherapy (XELOX); HLX22(25mg/kg)+Trastuzumab + Chemotherapy (XELOX)

Placebo DRUG

IV Q3W D1

Placebo +Trastuzumab + Chemotherapy (XELOX)

Trastuzumab DRUG

IV Q3W D1

HLX22(15mg/kg)+Trastuzumab + Chemotherapy (XELOX); HLX22(25mg/kg)+Trastuzumab + Chemotherapy (XELOX); Placebo +Trastuzumab + Chemotherapy (XELOX)

Oxaliplatin DRUG

IV Q3W D1

HLX22(15mg/kg)+Trastuzumab + Chemotherapy (XELOX); HLX22(25mg/kg)+Trastuzumab + Chemotherapy (XELOX); Placebo +Trastuzumab + Chemotherapy (XELOX)

Capecitabine DRUG

PO Q3W D1-D14

HLX22(15mg/kg)+Trastuzumab + Chemotherapy (XELOX); HLX22(25mg/kg)+Trastuzumab + Chemotherapy (XELOX); Placebo +Trastuzumab + Chemotherapy (XELOX)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Henlius Biotech: lead

Study Sites (1)

Shanghai East Hospital

Shanghai, China

Location

Related Publications (1)

• Li N, Qiu M, Zhang Y, Yang M, Lu L, Li W, Ma Y, Hou X, Sun G, Cai M, Wang J, Lu J, Zhong D, Huo Z, Zhang J, Yin X, Deng J, Liu Z, Pan H, Chen Y, Yang F, Yu H, Li J, Wang Q, Zhu J, Li J. A randomized phase 2 study of HLX22 plus trastuzumab biosimilar HLX02 and XELOX as first-line therapy for HER2-positive advanced gastric cancer. Med. 2024 Oct 11;5(10):1255-1265.e2. doi: 10.1016/j.medj.2024.06.004. Epub 2024 Jul 9.

  PMID: 38986608 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Trastuzumab; Oxaliplatin; Capecitabine

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2021
• First Posted: June 1, 2021
• Study Start: September 29, 2021
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: April 15, 2024

Record last verified: 2024-04

Locations

CN (1)