Clinical trial NCT01671774: Safety and Activity of IMAB362 in Combination With Zoledronic Acid and Interleukin-2 in CLDN18.2-positive Gastric Cancer
Official title: Multicenter, Open-label, Exploratory Phase I Pilot Study to Investigate Safety, Pharmacodynamics, and Pharmacokinetics of Immunological Effects and Activity of Combining Multiple Doses of IMAB362 With Immunomodulation (Zoledronic Acid, Interleukin-2) in Patients With Advanced Adenocarcinoma of the Stomach, the Lower Esophagus, or the Gastroesophageal Junction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: CLDN18.2-positive Gastric Adenocarcinoma
CLDN18.2-positive Adenocarcinoma of the Gastroesophageal Junction
CLDN18.2-positive Adenocarcinoma of Esophagus
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2012-08-24
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Safety and Tolerability
timeFrame: at least 18 months
measure: Immune cell profile and kinetics
timeFrame: at least 18 months
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: at least 18 months
measure: Objective tumor response rate (ORR)
timeFrame: at least 18 months
measure: Disease control rate (DCR)
timeFrame: at least 18 months
measure: Duration of response (DOR)
timeFrame: at least 18 months
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Institut für Klinische Forschung, Krankenhaus Nordwest GmbH
state: Hessen
city: Dresden
country: Germany
facility: BAG / Onkologische Schwerpunktpraxis
state: Sachsen
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin - CVK, Med. Klinik m.S. Hämatologie und Onkologie
city: Freiburg
country: Germany
facility: Freiburg University Medical Center, Department of Internal Medicine II, Gastroenterology and Hepatology
city: Leipzig
country: Germany
facility: Leipzig University Hospital, University Cancer Center (UCCL)
city: Tübingen
country: Germany
facility: University Hospital Tuebingen, Department of Internal Medicine I - Gastroenterology, Hepatology, Infectious Diseases
city: Ulm
country: Germany
facility: Ulm University Hospital, Center for Internal Medicine
city: Liepaja
country: Latvia
facility: Piejuras Hospital, Oncology Clinic
city: Riga
country: Latvia
facility: Riga East University Hospital, LLC, Latvian Oncology Center
Study officials:
References: