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JOURNAL ONKOLOGIE – STUDIE

DAREON™-9: A Study to Test How Well Different Doses of BI 764532 Are Tolerated by People With Small Cell Lung Cancer When Taken Together With Topotecan

Rekrutierend

NCT-Nummer:
NCT05990738

Studienbeginn:
Januar 2024

Letztes Update:
30.04.2024

Wirkstoff:
BI 764532, Topotecan

Indikation (Clinical Trials):
Small Cell Lung Carcinoma

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 1

Sponsor:
Boehringer Ingelheim

Collaborator:
-

Kontakt

Studienlocations
(3 von 7)

Universitätsklinikum Carl Gustav Carus Dresden
01307 Dresden
(Sachsen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Boehringer Ingelheim
Phone: 08007234742
E-Mail: deutschland@bitrialsupport.com» Ansprechpartner anzeigen
Hautkrebszentrum Universitätsklinikum Erlangen
Ulmenweg 18
91054 Erlangen
(Bayern)
DeutschlandRekrutierend» Google-Maps
Ansprechpartner:
Boehringer Ingelheim
Phone: 08007234742
E-Mail: deutschland@bitrialsupport.com» Ansprechpartner anzeigen
Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
69126 Heidelberg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Boehringer Ingelheim
Phone: 08007234742
E-Mail: deutschland@bitrialsupport.com» Ansprechpartner anzeigen
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
55131 Mainz
(Rheinland-Pfalz)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Boehringer Ingelheim
Phone: 08007234742
E-Mail: deutschland@bitrialsupport.com» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

Brief Summary:

This study is open to adults with extensive stage small cell lung cancer. The study is in

people with advanced cancer that had previously received platinum-based chemotherapy and are

eligible to receive topotecan treatment.

The purpose of this study is to find out the highest dose of BI 764532 that people can

tolerate when taken together with topotecan. BI 764532 is an antibody-like molecule that may

help the immune system fight cancer. Participants get BI 764532 and topotecan as infusions

into a vein. As an alternative, topotecan may also be taken orally (tablets).

Participants may continue to take BI 764532 as long as they benefit from treatment and can

tolerate it. During this time, participants visit the study site regularly. The visits also

depend on the response to the treatment. At the study visits, the doctors check the health of

the participants, take necessary laboratory tests, and note any health problems that could

have been caused by the study treatment.

Ein-/Ausschlusskriterien

Inclusion Criteria:

1. Male or female participants ≥18 years old and at least at the legal age of consent in

countries where it is greater than 18 years at the time of signature of the informed

consent form (ICF).

2. Signed and dated written informed consent in accordance with International Conference

of Harmonization-Good Clinical Practice (ICH-GCP) and local legislation prior to

admission to the trial

3. Histologically or cytologically confirmed small cell lung cancer (SCLC)

4. Extensive stage - small cell lung cancer (ES-SCLC) that progressed or recurred

following platinum-based treatment, and anti- programmed cell death protein 1 (PD-1)

or programmed cell death ligand 1 (PD-L1) as applicable

5. Patients must be eligible for topotecan treatment according to label

6. Availability of archival tumour tissue sample

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

criteria apply

Exclusion Criteria:

1. Previous treatment in this trial

2. Current enrolment in another investigational device or drug trial, or <30 days since

ending another investigational device or drug trial(s)

3. Untreated or symptomatic brain metastases. Participants with treated, stable brain

metastases are eligible provided they meet the following criteria:

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

(for radiotherapy) or 4 weeks (for major brain metastases surgery) 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.

4. Presence of leptomeningeal carcinomatosis

5. Previous treatment with T cell engager (TcE) or cell therapies targeting delta-like

ligand 3 (DLL3).

6. Persistent toxicity from previous treatments that has not resolved to ≤ Common

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

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

replacement therapy).

7. Major surgery (major according to the investigator's assessment) within 28 days prior

to first administration of BI 764532 or planned during treatment period, e.g. hip

replacement.

8. Previous or concomitant malignancies other than the one treated in this trial within

the last 2 years except

1. effectively treated non-melanoma skin cancers

2. effectively treated carcinoma in situ of the cervix

3. effectively treated ductal carcinoma in situ

4. other effectively treated malignancy that is considered cured by local treatment

Further exclusion criteria apply

Studien-Rationale

Primary outcome:

1. Part A: Occurrence of dose limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period (Time Frame - up to 9 weeks)

2. Part B: Occurrence of DLTs during the on-treatment period (Time Frame - up to 36 months)

3. Part B: Occurrence of AEs during the on-treatment period (Time Frame - up to 36 months)

Secondary outcome:

1. Part A: Occurrence of DLTs during the on-treatment period (Time Frame - up to 36 months)

2. Part A: Occurrence of AEs during the on-treatment period (Time Frame - up to 36 months)

3. Part B: Objective response (Time Frame - up to 36 months)

4. Part B: Duration of response (Time Frame - up to 36 months)

Studien-Arme

  • Experimental: Part A: BI 764532 low dose + topotecan
  • Experimental: Part A: BI 764532 medium dose + topotecan
  • Experimental: Part A: BI 764532 high dose + topotecan
  • Experimental: Part B: BI 764532 + topotecan

Geprüfte Regime

  • BI 764532:
    BI 764532
  • Topotecan:
    Topotecan

Quelle: ClinicalTrials.gov


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