Safety and Activity of IMAB362 in Combination With Zoledronic Acid and Interleukin-2 in CLDN18.2-positive Gastric Cancer
- Conditions
- CLDN18.2-positive Gastric AdenocarcinomaCLDN18.2-positive Adenocarcinoma of the Gastroesophageal JunctionCLDN18.2-positive Adenocarcinoma of Esophagus
- Interventions
- Registration Number
- NCT01671774
- Lead Sponsor
- Astellas Pharma Global Development, Inc.
- Brief Summary
The purpose of the trial is to assess the immunological effects and their kinetics, the safety and activity of IMAB362 plus Zoledronic acid with/without low to intermediate doses of Interleukin-2 in subjects with advanced gastroesophageal cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 29
- Histologically confirmed adenocarcinoma of the stomach, the esophagus or the gastroesophageal junction
- Inoperable locally advanced disease, resections with R0, R1 or R2 outcome or metastatic disease.
- CLDN18.2 expression confirmed by immunohistochemistry in paraffin embedded tumor tissue sample.
- Measurable and/or non-measurable disease as defined according to RECIST v1.1
- Age ≥ 18 years
- Written informed consent
- ECOG performance status (PS) 0-1
- Life expectancy > 3 months
- Prior hypersensitivity reaction or intolerance to one of the compounds of the study treatment
- Known HIV infection or known symptomatic hepatitis (A, B, C)
- Clinical symptoms of cerebral metastases
- Pregnancy or breastfeeding
- Patients treated with any bisphosphonate-based therapeutic for any indication during the previous year
- Hypocalcemia that requires medication. Corrected (adjusted for serum albumin) serum calcium < 8 mg/dl (2 mmol/L) or > 12 mg/dL (3.0 mmol/L)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description IMAB362 + ZA IMAB362 Participants received IMAB362 on Day 1 of each 3-week cycle (every 3 weeks). Participants received ZA on Day 1. IMAB362 + ZA Zoledronic acid Participants received IMAB362 on Day 1 of each 3-week cycle (every 3 weeks). Participants received ZA on Day 1. IMAB362 + ZA + IL-2 (3 million IU) Interleukin-2 (3 million IU) Participants received IMAB362 on Day 1 of each 3-week cycle (every 3 weeks). Participants received ZA on Day 1 and IL-2 on Days 1 to 3 of Cycles 1 and 3 only. IMAB362 IMAB362 Participants received IMAB362 only on Day 1 of each cycle every 3 weeks. IMAB362 + ZA + IL-2 (3 million IU) IMAB362 Participants received IMAB362 on Day 1 of each 3-week cycle (every 3 weeks). Participants received ZA on Day 1 and IL-2 on Days 1 to 3 of Cycles 1 and 3 only. IMAB362 + ZA + IL-2 (1 million IU) Interleukin-2 (1 million IU) Participants received IMAB362 on Day 1 of each 3-week cycle (every 3 weeks). Participants received ZA on Day 1 and IL-2 on Days 1 to 3 of Cycles 1 and 3 only. IMAB362 + ZA + IL-2 (1 million IU) IMAB362 Participants received IMAB362 on Day 1 of each 3-week cycle (every 3 weeks). Participants received ZA on Day 1 and IL-2 on Days 1 to 3 of Cycles 1 and 3 only. IMAB362 + ZA + IL-2 (1 million IU) Zoledronic acid Participants received IMAB362 on Day 1 of each 3-week cycle (every 3 weeks). Participants received ZA on Day 1 and IL-2 on Days 1 to 3 of Cycles 1 and 3 only. IMAB362 + ZA + IL-2 (3 million IU) Zoledronic acid Participants received IMAB362 on Day 1 of each 3-week cycle (every 3 weeks). Participants received ZA on Day 1 and IL-2 on Days 1 to 3 of Cycles 1 and 3 only.
- Primary Outcome Measures
Name Time Method Safety and Tolerability at least 18 months Descriptive statistics for treatments will be given on the number of patients whose treatment had to be reduced, delayed or permanently stopped.
Immune cell profile and kinetics at least 18 months Descriptive statistics for treatments will be given on the number and activity of immune cells in peripheral blood of patients.
- Secondary Outcome Measures
Name Time Method Progression-free survival (PFS) at least 18 months PFS is defined as the time from registration of therapy to the first observation of disease progression or death from any cause or last tumor evaluation if free of progression. For patients who have not progressed either clinically or on the last scan, they will be censured as of the last tumor evaluation.
Duration of response (DOR) at least 18 months Duration of response is determined as the time when criteria for CR, PR, and SD are first met until the first date that recurrent or progressive disease or death occurs.
Objective tumor response rate (ORR) at least 18 months ORR comprises the fraction of patients with CR, PR according to RECIST v1.1. It is set in relation to the ITT population and PP population.
Disease control rate (DCR) at least 18 months DCR is defined as the fraction of patients with CR or PR or SD according to RECIST v1.1. It is set in relation to the ITT population and PP population.
Trial Locations
- Locations (9)
Riga East University Hospital, LLC, Latvian Oncology Center
🇱🇻Riga, Latvia
Leipzig University Hospital, University Cancer Center (UCCL)
🇩🇪Leipzig, Germany
Institut für Klinische Forschung, Krankenhaus Nordwest GmbH
🇩🇪Frankfurt, Hessen, Germany
University Hospital Tuebingen, Department of Internal Medicine I - Gastroenterology, Hepatology, Infectious Diseases
🇩🇪Tübingen, Germany
Piejuras Hospital, Oncology Clinic
🇱🇻Liepaja, Latvia
Ulm University Hospital, Center for Internal Medicine
🇩🇪Ulm, Germany
Charité Universitätsmedizin Berlin - CVK, Med. Klinik m.S. Hämatologie und Onkologie
🇩🇪Berlin, Germany
Freiburg University Medical Center, Department of Internal Medicine II, Gastroenterology and Hepatology
🇩🇪Freiburg, Germany
BAG / Onkologische Schwerpunktpraxis
🇩🇪Dresden, Sachsen, Germany