Safety and Activity of IMAB362 in Combination With Zoledronic Acid and Interleukin-2 in CLDN18.2-positive Gastric Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-16

Study Completion Date

2014-10-13

Brief Summary

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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.

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Detailed Description

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Conditions

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CLDN18.2-positive Gastric Adenocarcinoma CLDN18.2-positive Adenocarcinoma of the Gastroesophageal Junction CLDN18.2-positive Adenocarcinoma of Esophagus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Study Groups

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IMAB362 + ZA

Participants received IMAB362 on Day 1 of each 3-week cycle (every 3 weeks). Participants received ZA on Day 1.

Group Type EXPERIMENTAL

IMAB362

Intervention Type DRUG

800 mg/m2 on d 1 of cycle 1. 600 mg/m2 on d 1 of every other cycle

Zoledronic acid

Intervention Type DRUG

4 mg on d 1 of cycle 1 and cycle 3

IMAB362 + ZA + IL-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.

Group Type EXPERIMENTAL

IMAB362

Intervention Type DRUG

800 mg/m2 on d 1 of cycle 1. 600 mg/m2 on d 1 of every other cycle

Zoledronic acid

Intervention Type DRUG

4 mg on d 1 of cycle 1 and cycle 3

Interleukin-2 (1 million IU)

Intervention Type DRUG

1 million IU on day 1, 2 and 3 of cycles 1 and 3.

IMAB362 + ZA + IL-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.

Group Type EXPERIMENTAL

IMAB362

Intervention Type DRUG

800 mg/m2 on d 1 of cycle 1. 600 mg/m2 on d 1 of every other cycle

Zoledronic acid

Intervention Type DRUG

4 mg on d 1 of cycle 1 and cycle 3

Interleukin-2 (3 million IU)

Intervention Type DRUG

3 million IU on day 1, 2 and 3 of cycles 1 and 3.

IMAB362

Participants received IMAB362 only on Day 1 of each cycle every 3 weeks.

Group Type ACTIVE_COMPARATOR

IMAB362

Intervention Type DRUG

800 mg/m2 on d 1 of cycle 1. 600 mg/m2 on d 1 of every other cycle

Interventions

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IMAB362

800 mg/m2 on d 1 of cycle 1. 600 mg/m2 on d 1 of every other cycle

Intervention Type DRUG

Zoledronic acid

4 mg on d 1 of cycle 1 and cycle 3

Intervention Type DRUG

Interleukin-2 (1 million IU)

1 million IU on day 1, 2 and 3 of cycles 1 and 3.

Intervention Type DRUG

Interleukin-2 (3 million IU)

3 million IU on day 1, 2 and 3 of cycles 1 and 3.

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No