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Completed

NCT Number: NCT01671774

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

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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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Institut für Klinische Forschung, Krankenhaus Nordwest GmbH, Frankfurt am Main, Hesse, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

IMAB362

Drug

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

Zoledronic acid

Drug

4 mg on d 1 of cycle 1 and cycle 3

Interleukin-2 (1 million IU)

Drug

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

Interleukin-2 (3 million IU)

Drug

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

Primary outcomes

  1. Safety and Tolerability

    Time frame: 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.

  2. Immune cell profile and kinetics

    Time frame: 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 outcomes

  1. Progression-free survival (PFS)

    Time frame: 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.

  2. Objective tumor response rate (ORR)

    Time frame: 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.

  3. Disease control rate (DCR)

    Time frame: 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.

  4. Duration of response (DOR)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Astellas Pharma Global Development, Inc.

Industry

Registry information

Official study 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

Acronym: PILOT

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Aug 24, 2012
Registry last updated
Nov 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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