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CLDN18.2-positive Gastric AdenocarcinomaPhase 1PILOTNCT01671774

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

A Phase 1 study testing IMAB362, Zoledronic acid and Interleukin-2 (1 million IU) in people with CLDN18.2-positive Gastric Adenocarcinoma and CLDN18.2-positive Adenocarcinoma of the Gastroesophageal Junction, run by Astellas Pharma Global Development, Inc. at 9 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
IMAB362, Zoledronic acid and Interleukin-2 (1 million IU)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
9 sitesin 2 countries
Study dates
16 Oct 2012to 13 Oct 2014
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

9 sites in 2 countries.

9 sites in 2 countries

Germany7 sites

  • Charité Universitätsmedizin Berlin - CVK, Med. Klinik m.S. Hämatologie und Onkologie

    Berlin, 13353

  • BAG / Onkologische Schwerpunktpraxis

    Dresden, Saxony, 01307

  • Institut für Klinische Forschung, Krankenhaus Nordwest GmbH

    Frankfurt am Main, Hesse, 60488

  • Freiburg University Medical Center, Department of Internal Medicine II, Gastroenterology and Hepatology

    Freiburg im Breisgau, 79106

  • Leipzig University Hospital, University Cancer Center (UCCL)

    Leipzig, 04109

  • University Hospital Tuebingen, Department of Internal Medicine I - Gastroenterology, Hepatology, Infectious Diseases

    Tübingen, 72076

  • Ulm University Hospital, Center for Internal Medicine

    Ulm, 89070

Other trials in Germany

Latvia2 sites

  • Piejuras Hospital, Oncology Clinic

    Liepāja, 3401

  • Riga East University Hospital, LLC, Latvian Oncology Center

    Riga, LV1038

Other trials in Latvia

About this study

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

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.

Being tested
IMAB362, Zoledronic acid, Interleukin-2 (1 million IU), Interleukin-2 (3 million IU)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IMAB362Drug

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

  • Zoledronic acidDrug

    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.

Study groups in NCT01671774
Study groupRoleWhat they receive
IMAB362 + ZAExperimentalParticipants received IMAB362 on Day 1 of each 3-week cycle (every 3 weeks). Participants received ZA on Day 1.
Receives: Drug: IMAB362; Drug: Zoledronic acid
IMAB362 + ZA + IL-2 (1 million IU)ExperimentalParticipants 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.
Receives: Drug: IMAB362; Drug: Zoledronic acid; Drug: Interleukin-2 (1 million IU)
IMAB362 + ZA + IL-2 (3 million IU)ExperimentalParticipants 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.
Receives: Drug: IMAB362; Drug: Zoledronic acid; Drug: Interleukin-2 (3 million IU)
IMAB362Active comparatorParticipants received IMAB362 only on Day 1 of each cycle every 3 weeks.
Receives: Drug: IMAB362

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and Tolerability

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

    Measured: at least 18 months

  2. Immune cell profile and kinetics

    Descriptive statistics for treatments will be given on the number and activity of immune cells in peripheral blood of patients.

    Measured: at least 18 months

Secondary outcomes (4)

  1. Progression-free survival (PFS)

    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.

    Measured: at least 18 months

  2. Objective tumor response rate (ORR)

    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.

    Measured: at least 18 months

  3. Disease control rate (DCR)

    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.

    Measured: at least 18 months

  4. Duration of response (DOR)

    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.

    Measured: at least 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2012 (estimated)
  2. Study start16 Oct 2012
  3. Primary completion13 Oct 2014
  4. Study completion13 Oct 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01671774
Sponsor's protocol ID
GM-IMAB-001-04
Other IDs
2011-005509-64
Acronym
PILOT
Status last verified
Nov 2024
First submitted
21 Aug 2012
Last updated
14 Nov 2024
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Publications

  • Lordick F, Thuss-Patience P, Bitzer M, Maurus D, Sahin U, Tureci O. Immunological effects and activity of multiple doses of zolbetuximab in combination with zoledronic acid and interleukin-2 in a phase 1 study in patients with advanced gastric and gastroesophageal junction cancer. J Cancer Res Clin Oncol. 2023 Aug;149(9):5937-5950. doi: 10.1007/s00432-022-04459-3. Epub 2023 Jan 6.

    PubMed 36607429

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IMAB362, Zoledronic acid and Interleukin-2 (1 million IU) in people with CLDN18.2-positive Gastric Adenocarcinoma and CLDN18.2-positive Adenocarcinoma of the Gastroesophageal Junction, run by Astellas Pharma Global Development, Inc. at 9 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Germany, Latvia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and Tolerability (time frame: at least 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01671774, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2024.

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