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

NCT ID: NCT04908813

Last Updated: 2024-04-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-29
• Study Completion Date: 2025-12-31

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).

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).

Conditions

Gastric Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

HLX22

Intervention Type: DRUG

IV Q3W D1

Trastuzumab

Intervention Type: DRUG

IV Q3W D1

Oxaliplatin

Intervention Type: DRUG

IV Q3W D1

Capecitabine

Intervention Type: DRUG

PO Q3W D1-D14

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

Group Type: EXPERIMENTAL

HLX22

Intervention Type: DRUG

IV Q3W D1

Trastuzumab

Intervention Type: DRUG

IV Q3W D1

Oxaliplatin

Intervention Type: DRUG

IV Q3W D1

Capecitabine

Intervention Type: DRUG

PO Q3W D1-D14

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

Group Type: ACTIVE_COMPARATOR

Placebo

Intervention Type: DRUG

IV Q3W D1

Trastuzumab

Intervention Type: DRUG

IV Q3W D1

Oxaliplatin

Intervention Type: DRUG

IV Q3W D1

Capecitabine

Intervention Type: DRUG

PO Q3W D1-D14

Interventions

HLX22

IV Q3W D1

Intervention Type: DRUG

Placebo

IV Q3W D1

Intervention Type: DRUG

Trastuzumab

IV Q3W D1

Intervention Type: DRUG

Oxaliplatin

IV Q3W D1

Intervention Type: DRUG

Capecitabine

PO Q3W D1-D14

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Henlius Biotech

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai East Hospital

Shanghai, , China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 38986608 (View on PubMed)

Other Identifiers

HLX22-GC-201

Identifier Type: -

Identifier Source: org_study_id