2024-516633-12-00
Recruiting
Phase 3
A Randomized, Double-blinded, Multicenter, Phase Ⅲ Clinical Study of HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) in Combination with Trastuzumab and Chemotherapy (XELOX) versus Trastuzumab and Chemotherapy (XELOX) with or without Pembrolizumab for the First Line Treatment of Locally Advanced or Metastatic Gastroesophageal Junction and Gastric Cancer
Shanghai Henlius Biotech Inc.88 sites in 4 countries91 target enrollmentStarted: November 22, 2024Last updated:
Overview
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Shanghai Henlius Biotech Inc.
- Enrollment
- 91
- Locations
- 88
- Primary Endpoint
- Progression-free survival (PFS) (assessed by the Blinded Independent Central Review [BICR] per RECIST v1.1).
Overview
Brief Summary
To evaluate the efficacy of HLX22 in combination with trastuzumab + chemotherapy versus trastuzumab + chemotherapy ± pembrolizumab as first-line treatment for patients with locally advanced/metastatic gastroesophageal junction and gastric cancer.
Detailed Description
In experimental group: HLX22 (15 mg/kg) + trastuzumab + chemotherapy (XELOX) ± placebo (for pembrolizumab), once every 3 weeks (Q3W).
In control group: Placebo (for HLX22) + trastuzumab + chemotherapy (XELOX) ± pembrolizumab, Q3W.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 years to 65+ years (18-64 Years, 65+ Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Voluntary participation in the clinical study; fully understands and is informed of the study and has signed the ICF; willing to comply with and able to complete all trial procedures.
- •HIV antibody (–); if HIV antibody (+), the subject should establish antiretroviral therapy for at least four weeks and have an HIV viral load less than 400 copies/mL prior to enrollment.
- •Has adequate organ function as defined in the protocol.
- •Female subjects of childbearing potential had to have a negative blood pregnancy test within 7 days before randomization. Female subjects of childbearing potential and male subjects with female partners of childbearing potential had to adopt at least one highly effective contraceptive measure as defined by Clinical Trials Facilitation Group（CTFG）(such as intra-uterine contraceptive device, contraceptive pill or condom) during the study treatment period, and at least nine months after the last dose of study treatment.
- •Male/female who were at least 18 years of age on the day of signing the informed consent.
- •With histologically or cytologically confirmed diagnosis of previously untreated, locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.
- •Had measurable disease as assessed by BICR according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, the target lesion must not be a bone metastatic lesion only.
- •HER2-positive tumor defined as either IHC 3+ or IHC 2+ in combination with ISH+ or FISH+, as assessed by a central laboratory on a primary or metastatic tumor.
- •ECOG PS within 7 days before randomization: 0-
- •Expected survival ≥ 6 months.
Exclusion Criteria
- •Patients with other malignant tumors within 2 years before the randomization. Patients with localized tumors that have been resolved, such as cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, and thyroid carcinoma, can be enrolled.
- •Known dihydropyrimidine dehydrogenase deficiency or current use of antiviral drug sorivudine or its chemically related analogs, such as brivudine.
- •Has had previous therapy for locally advanced unresectable or metastatic gastric/GEJ cancer. Patient may have received prior neoadjuvant or adjuvant therapy as long as it was completed at least 6 months prior to randomization and there was no evidence of progression within the timeframe.
- •Prior use of doxorubicin with in vivo concentrations > 360 mg/m2 (or equivalent) as described in the protocol.
- •Previous treatment with any HER2-target therapy.
- •Residual toxicity resulting from previous therapy. Alopecia is permitted.
- •Active gastrointestinal bleeding (Grade ≥ 2 according to National Cancer Institute [NCI] CTCAE v5.0).
- •Presence of central nervous system (CNS) metastases and/or carcinomatous meningitis.
- •Occurrence of cerebrovascular accidents, myocardial infarction, unstable angina and poorly controlled arrhythmia (including QTc interval ≥ 470 ms) (QTc interval calculated according to the Fridericia formula) within half a year prior to the randomization
- •According to the New York Heart Association (NYHA) classification, subjects with class III or IV cardiac insufficiency or color Doppler echocardiogram (ECHO): left ventricular ejection fraction (LVEF) < 55%.
Outcomes
Primary Outcomes
Progression-free survival (PFS) (assessed by the Blinded Independent Central Review [BICR] per RECIST v1.1).
Progression-free survival (PFS) (assessed by the Blinded Independent Central Review [BICR] per RECIST v1.1).
Overall survival (OS).
Overall survival (OS).
Secondary Outcomes
- Progression-free survival (PFS) (assessed by investigator per RECIST v1.1).
- Objective response rate (ORR) (assessed by BICR and investigator per RECIST v1.1).
- Progression-free survival on next line of therapy (PFS2) (assessed by investigator per RECIST v1.1)
- Duration of response (DOR) (assessed by BICR and investigator per RECIST v1.1).
- Incidence of adverse events (AEs) and serious adverse events (SAEs).
- Pharmacokinetics (PK): concentration of HLX22 in serum.
- Immunogenicity evaluation: incidence of anti-drug antibody (ADA) and neutralizing antibody (NAb) of HLX22.
- Quality of life assessment.
Investigators
Clinical Development
Scientific
Shanghai Henlius Biotech Inc.
Study Sites (88)
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