Combination therapy for advanced HER2-positive gastric cancer

A Phase 1B/2 Study of Trastuzumab, Bevacizumab with Paclitaxel for HER2-positive Gastric Cancer in a Second-line Therapy (TREAZURE)

This study is testing a new combination of three drugs to see if it can help people with advanced HER2-positive gastric cancer who didn’t get better with their first treatment.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 47 (estimated)
• Sex: All
• Sponsor: Kangbuk Samsung Hospital (other)
• Drugs / interventions: chemotherapy, immunotherapy, radiation, trastuzumab, bevacizumab
• Locations: 1 site (Seoul)
• Trial ID: NCT05640830 on ClinicalTrials.gov

What this trial studies

This multicenter, open-label, phase 2 study evaluates the effectiveness of a combination of trastuzumab, bevacizumab, and paclitaxel as a second-line treatment for patients with HER2-positive advanced gastric cancer who have not responded to first-line chemotherapy. The treatment regimen includes specific dosing schedules for each drug to maintain therapeutic levels while managing side effects. The study aims to assess the safety and efficacy of this triple combination therapy in improving patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 19 and older with HER2-positive advanced gastric cancer who have progressed after first-line therapy.

Not a fit: Patients who have not been diagnosed with HER2-positive gastric cancer or those who have not progressed after first-line therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with advanced HER2-positive gastric cancer who have limited treatment alternatives.

How similar studies have performed: Other studies have shown promising results with similar combination therapies in HER2-positive cancers, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. HER2-positive advanced gastric cancer

   * Defined as IHC 2+, which is IHC 3+ or SISH + (or FISH) evaluated by laboratory tests. (SISH positivity is defined as the ratio of the HER2 gene copy number to the CEP17 signal ≥ 2.0)
   * or significant overexpression of HER2 protein on target proteomic analysis (multiple reaction monitoring)
2. Patients who have progressed in response to one systemic anticancer therapy for advanced gastric cancer
3. Patients who are willing and able to write a written consent form for this trial.
4. Patients aged 19 years or older at the time of signing the subject consent form.
5. Patients with measurable or evaluable lesions according to RECIST 1.1.
6. ECOG activity status 0, 1 or 2
7. as patients with adequate organ function

   * Absolute neutrophil (ANC) ≥1.0 x 109/L, platelet ≥100 x 109/L, hemoglobin ≥9 g/dL, serum creatinine ≤1.5 x ULN, total bilirubin ≤3.0 mg on laboratory tests within 2 weeks before starting treatment /dL, AST/ALT ≤5 x ULN
   * Echocardiogram EF ≥55% or MUGA scan ≥50%

Exclusion Criteria:

1. Patients who have received chemotherapy, radiation therapy, immunotherapy or targeted therapy for gastric cancer within the past 2 weeks.
2. Patients who have experienced Grade 3-4 gastrointestinal bleeding within 3 months
3. Patients who have experienced an arteriovascular embolism event, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular disorder, or unstable angina within 6 months
4. Ongoing or active infection, symptomatic congestive heart failure, unstable angina, symptomatic or poorly controlled cardiac arrhythmias, uncontrolled thrombotic or hemorrhagic disorders, or any other serious medical disorder not controlled in the investigator's judgment patient with
5. Patients with a history of gastrointestinal perforation or fistula within 6 months.
6. Concomitant diagnosis of cancer in another site or history of active malignant tumor within the past 3 years

   * Excluding fully cured basal cell carcinoma and thyroid cancer, in situ cervical cancer

Where this trial is running

Seoul

• Kangbuk Samsung Hospital — Seoul, South Korea (RECRUITING)

Study contacts

• Principal investigator: Dong-Hoe Koo, MD,PhD — Kangbuk Samsung Hospital
• Study coordinator: Dong-Hoe Koo, MD,PhD

Conditions: HER2-positive Advanced Gastric Cancer, HER2-positive gastric cancer, trastuzumab, bevacizumab & paclitaxel