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JOURNAL ONKOLOGIE – STUDIE

A Study to Test Different Doses of BI 764532 in Patients With Small Cell Lung Cancer and Other Neuroendocrine Tumours That Are Positive for DLL3

Rekrutierend

NCT-Nummer:
NCT04429087

Studienbeginn:
Juli 2020

Letztes Update:
10.04.2024

Wirkstoff:
BI 764532 - parenteral 1, BI 764532 - parenteral 2

Indikation (Clinical Trials):
Carcinoma, Neoplasms, Lung Neoplasms, Small Cell Lung Carcinoma

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 1

Sponsor:
Boehringer Ingelheim

Collaborator:
-

Kontakt

Studienlocations
(3 von 11)

Universitätsklinikum Carl Gustav Carus Dresden
01307 Dresden
(Sachsen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Boehringer Ingelheim
Phone: 08007234742
E-Mail: deutschland@bitrialsupport.com» Ansprechpartner anzeigen
Universitätsklinikum Köln (AöR)
50937 Köln
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Boehringer Ingelheim
Phone: 08007234742
E-Mail: deutschland@bitrialsupport.com» Ansprechpartner anzeigen
Washington University School of Medicine
63110 Saint Louis
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Boehringer Ingelheim
Phone: 833-602-2368
E-Mail: unitedstates@bitrialsupport.com» Ansprechpartner anzeigen
University of Pittsburgh Medical Center
15232 Pittsburgh
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Boehringer Ingelheim
Phone: 833-602-2368
E-Mail: unitedstates@bitrialsupport.com» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

Brief Summary:

This study is open to adults with small cell lung cancer and other neuroendocrine cancers

that are positive for the tumour marker delta-like 3 (DLL3). The study is in people with

advanced cancer for whom previous treatment was not successful or no standard treatment

exists.

The purpose of this study is to find out the highest dose of BI 764532 and the best treatment

schedule that people can tolerate. BI 764532 is an antibody-like molecule (DLL3/CD3

bispecific) that may help the immune system fight cancer. In this study, BI 764532 is given

to people for the first time. That means no clinical data are available for BI 764532.

Participants get BI 764532 either weekly or once every 3 weeks. If there is benefit for the

participants and if they can tolerate it, the treatment is given for a maximum of 3 years.

During this time, participants visit the study site about 20 times depending on the response

to the treatment. Doctors record any unwanted effects and regularly check the general health

of the participants.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Signed and dated, written informed consent form (ICF2, ICF3 or ICF4) in accordance

with International Council for Harmonisation of Technical Requirements for

Pharmaceuticals for Human Use (ICH) - Good Clinical Practice (GCP) and local

legislation prior to any trial-specific procedures, sampling, or analyses.

- Locally advanced or metastatic cancer not amenable to curative treatment; of following

histologies:

- Small cell lung carcinoma (SCLC)

- Large cells neuroendocrine lung carcinoma (LCNEC)

- Neuroendocrine carcinoma (NEC) or small cell carcinoma of any other origin

- Tumours must be positive for DLL3 expression (on archived tissue or instudy fresh

biopsy) according to central pathology review in order to start BI 764532

- Patients with tumours with mixed histologies for any above type are eligible only

if neuroendocrine carcinoma/small tumor cells component is predominant and

represent at least 50% of the overall tumour tissue.

- For back-fill cohorts only: patient has agreed to and signed an IC to provide

mandatory pre-treatment and on-treatment fresh tumor biopsy.

- Patient has failed or is not eligible for available standard therapies according to

local guidelines. Standard therapies should include at least one line of chemotherapy

that should include platinum for patients with small cells carcinoma tumors

histologies.

- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

- At least one evaluable lesion outside of CNS as defined per modified Response

Evaluation Criteria In Solid Tumors (RECIST) 1.1

- Subjects with brain metastases are eligible provided they meet the following criteria:

- Radiotherapy or surgery for brain metastases was completed at least 2 weeks prior

to the first administration of BI 764532

- Patient is off steroids for at least 7 days (physiologic doses of steroids are

permitted), and the patient is off anti-epileptic drugs for at least 7 days or on

stable doses of anti-epileptic drugs for malignant Central Nervous System (CNS)

disease.

- Adequate liver, bone marrow and renal organ function Further inclusion criteria apply.

Exclusion Criteria:

- Previous treatment with T cell Engager (TcE) or cell therapies targeting DLL3. Other

DLL3 targeting agents (like Rovalpituzumab tesirine (RovaT)) are allowed only if DLL3

positivity is documented after completion of treatment with DLL3 targeting agent in

post-treatment biopsy.

- Anticoagulant treatment that cannot be safely interrupted based on opinion of the

investigator if medically needed (e.g. biopsy).

- Persistent toxicity from previous treatments that has not resolved to = Common

Terminology Criteria for Adverse Events (CTCAE) Grade 1 (except for alopecia, CTCAE

Grade 2 neuropathy, asthenia/fatigue or grade 2 endocrinopathies controlled by

replacement therapy).

- Patient has a diagnosis of immunodeficiency or is receiving systemic steroid therapy

or any other form of immunosuppressive therapy within 7 days prior to the first dose

of BI 764532. Physiological replacement of steroids is allowed.

- Prior anti-cancer therapy:

- Patients who have been treated with any other anti-cancer drug within 3 weeks or

within 5 half-life periods (whichever is shorter) prior to first administration

of BI 764532.

- Patients who have been treated with extensive field radiotherapy including whole

brain irradiation within 2 weeks prior to first administration of BI 764532.

- Other active malignancy that could interfere with the prognosis and treatment of the

disease of the study.

- Major surgery within 28 days of first dose BI 764532.

- Women who are pregnant (including those who are considered to be possibly pregnant

based on the investigator's clinical judgement), nursing/breast feeding or who plan to

become pregnant or nurse while in the trial or within 35 days after the last dose of

study treatment.

- Active infection that requires medical therapy or other clinically significant

intervention or within 2 weeks prior to study entry confirmed (PCR test or other

applicable test as per local requirements) or suspected SARS-CoV-2 infection or close

contact with an individual with confirmed SARS-CoV-2 infection.

Further exclusion criteria apply.

Studien-Rationale

Primary outcome:

1. Arm 1 and Arm 2: Maximum tolerated dose (MTD) (Time Frame - up to 36 months):
Maximum tolerated dose (MTD) in any studied regimen defined as the highest dose with less than 25% risk of the true Dose Limiting Toxicity (DLT) rate being equal or above 33% during the MTD evaluation period. Separate MTDs will be determined for each Regimen.

2. Arm 1 and Arm 2: Number of patients with DLTs in the MTD evaluation period (Time Frame - up to 36 months)

Secondary outcome:

1. Arm 1 and Arm 2: Maximum measured concentration (Cmax) of BI 764532 (Time Frame - up to 36 months)

2. Arm 1 and Arm 2: Area under the concentration-time curve (AUCτ) of the analyte over a uniform dosing interval τ (Time Frame - up to 36 months)

3. Arm 1 and Arm 2: Objective response based on RECIST 1.1 criteria in patients with measurable disease (Time Frame - up to 36 months):
Objective response based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria in patients with measurable disease

Studien-Arme

  • Experimental: Arm 1: BI 764532
  • Experimental: Arm 2: BI 764532

Geprüfte Regime

  • BI 764532 - parenteral 1:
    BI 764532 - parenteral 1
  • BI 764532 - parenteral 2:
    BI 764532 - parenteral 2

Quelle: ClinicalTrials.gov


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