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 a Single Agent Chemotherapy

NCT05990738 | Active Not Recruiting Phase 1 FDA Drug

• 3 other identifiers: 1438-00092023-506007-26-00U1111-1293-4098
• Study Type: interventional
• Target: 69
• Locations: 5 countries
• Sites: 14

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 a single agent chemotherapy treatment. The purpose of this study is to find the highest dose of BI 764532 that people can tolerate when taken together with a single agent chemotherapy. BI 764532 is an antibody-like molecule that may help the immune system fight cancer. 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.

Conditions

Small Cell Lung Carcinoma (SCLC)

Outcome Measures

Primary Outcomes (3)

• Part A: Occurrence of dose limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period

  up to 9 weeks

• Part B: Occurrence of DLTs during the on-treatment period

  up to 36 months

• Part B: Occurrence of AEs during the on-treatment period

  up to 36 months

Secondary Outcomes (4)

• Part A: Occurrence of DLTs during the on-treatment period

  up to 36 months

• Part A: Occurrence of AEs during the on-treatment period

  up to 36 months

• Part B: Objective response

  up to 36 months

• Part B: Duration of response

  up to 36 months

Study Arms (4)

Part A: BI 764532 low dose + topotecan/single agent chemotherapy

EXPERIMENTAL

Drug: BI 764532; Drug: Topotecan; Drug: Single agent chemotherapy

Part A: BI 764532 medium dose + topotecan/single agent chemotherapy

EXPERIMENTAL

Drug: BI 764532; Drug: Topotecan; Drug: Single agent chemotherapy

Part A: BI 764532 high dose + topotecan/single agent chemotherapy

EXPERIMENTAL

Drug: BI 764532; Drug: Topotecan; Drug: Single agent chemotherapy

Part B: BI 764532 + topotecan

EXPERIMENTAL

Drug: BI 764532; Drug: Topotecan

Interventions

Single agent chemotherapy DRUG

single agent chemotherapy

Part A: BI 764532 high dose + topotecan/single agent chemotherapy; Part A: BI 764532 low dose + topotecan/single agent chemotherapy; Part A: BI 764532 medium dose + topotecan/single agent chemotherapy

BI 764532 DRUG

BI 764532

Also known as: Obrixtamig

Part A: BI 764532 high dose + topotecan/single agent chemotherapy; Part A: BI 764532 low dose + topotecan/single agent chemotherapy; Part A: BI 764532 medium dose + topotecan/single agent chemotherapy; Part B: BI 764532 + topotecan

Topotecan DRUG

Topotecan

Part A: BI 764532 high dose + topotecan/single agent chemotherapy; Part A: BI 764532 low dose + topotecan/single agent chemotherapy; Part A: BI 764532 medium dose + topotecan/single agent chemotherapy; Part B: BI 764532 + topotecan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.
• Histologically or cytologically confirmed small cell lung cancer (SCLC). Patients with tumours with mixed histology are eligible only if SCLC component is predominant and represent at least 50% of the overall tumour tissue.
• 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.
• Patients must be eligible for single agent chemotherapy treatment (used in the trial) according to label.
• Availability of archival tumour tissue sample.

You may not qualify if:

• Previous treatment in this trial.
• Current enrolment in another investigational device or drug trial, or \<30 days since ending another investigational device or drug trial(s).
• 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.
• Presence of leptomeningeal carcinomatosis.
• Prior participation in clinical trials of BI 764532, including receiving standard of care in these trials OR prior treatment with T cell engager (TcE) or cell therapies targeting delta-like ligand 3 (DLL3).
• 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).
• 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.
• Previous or concomitant malignancies other than the one treated in this trial within the last 2 years except
• effectively treated non-melanoma skin cancers
• effectively treated carcinoma in situ of the cervix
• effectively treated ductal carcinoma in situ

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (14)

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

Mayo Clinic - Florida

Jacksonville, Florida, 32224, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23219, United States

Location

INS Curie

Paris, 75005, France

Location

HOP Civil

Strasbourg, 67091, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

Universitätsklinikum Carl Gustav Carus Dresden

Dresden, 01307, Germany

Location

Universitätsklinikum Erlangen

Erlangen, 91054, Germany

Location

Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg

Heidelberg, 69126, Germany

Location

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, 55131, Germany

Location

Universitätsklinikum Würzburg AÖR

Würzburg, 97078, Germany

Location

Polish Mother's Memorial Hospital - Research Institute

Lodz, 93-338, Poland

Location

Leicester Royal Infirmary

Leicester, LE1 5WW, United Kingdom

Location

Related Links

• Related Info

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Topotecan

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2023
• First Posted: August 14, 2023
• Study Start: February 14, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 30, 2027
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (5); FR (3); PL (1); GB (1); US (4)