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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 Gastro-esophageal Junction.


Phase 1
18 Years
N/A
Open (Enrolling)
Both
CLDN18.2-positive Gastric Adenocarcinoma, CLDN18.2-positive Adenocarcinoma of Esophagus, CLDN18.2-positive Adenocarcinoma of the Gastroesophageal Junction

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Trial Information

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 Gastro-esophageal Junction.


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)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and Tolerability

Outcome Description:

Descriptive statistics for treatments will be given on the number of patients whose treatment had to be reduced, delayed or permanently stopped.

Outcome Time Frame:

at least 18 months

Safety Issue:

Yes

Authority:

Germany: Paul-Ehrlich-Institut

Study ID:

GM-IMAB-001-04

NCT ID:

NCT01671774

Start Date:

August 2012

Completion Date:

February 2014

Related Keywords:

  • CLDN18.2-positive Gastric Adenocarcinoma
  • CLDN18.2-positive Adenocarcinoma of Esophagus
  • CLDN18.2-positive Adenocarcinoma of the Gastroesophageal Junction
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Stomach Neoplasms

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