NCT05963867 A Study to Test How BI 764532 is Taken up by Tumours in People With Small-cell Lung Cancer or Neuroendocrine Cancer
| NCT ID | NCT05963867 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Boehringer Ingelheim |
| Condition | Small Cell Lung Carcinoma (SCLC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2024-08-06 |
| Primary Completion | 2026-08-10 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 12 participants in total. It began in 2024-08-06 with a primary completion date of 2026-08-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is open to adults with small cell lung cancer and other neuroendocrine cancers. 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 how a medicine called BI 764532 gets distributed in the body and in tumours. Participants get BI 764532 when starting treatment. In the first weeks, doctors check how BI 764532 is taken up in tumours by means of an imaging method. If there is benefit for the participants and if they can tolerate it, the treatment is given up to the maximum duration of the study. During this time, participants visit the study site regularly. The total number of visits depends on how they respond to and tolerate the treatment. Doctors record any unwanted effects and regularly check the general health of the participants.
Eligibility Criteria
Inclusion Criteria: * Age ≥18 years * Weight ≥ 60kg * Signed and dated, written informed consent form (ICF) in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to any trial-specific procedures, sampling, or analyses. * Patient who failed conventional treatment or for whom no therapy of proven efficacy exists or who is not eligible for established treatment options. Patient must have exhausted available treatment options known to prolong survival for their disease. Previous therapies should include at least one line of platinum-based chemotherapy. Previous therapy with anti Programmed Cell Death Protein 1 (PD-1) or Programmed Cell Death Ligand 1 (PD-L1) are allowed. * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. * At least one evaluable lesion outside of Central Nervous System (CNS) as defined per Response Evaluation Criteria in Solid Tumours (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 CNS disease. Further inclusion criteria apply. Exclusion Criteria: * 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 * other effectively treated malignancy that is considered cured by local treatment * Major injuries and/or surgery or bone fracture within 28 days of first dose BI 764532, or planned surgical procedures * Known leptomeningeal disease or spinal cord compression due to metastatic disease * Anticoagulant treatment that cannot be safely interrupted based on opinion of the investigator if medically needed * Active infection that requires medical therapy or other clinically significant intervention * Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 2 weeks prior to study entry (confirmed via polymerase chain reaction (PCR) test or other applicable test as per local requirements) or suspected SARS-CoV-2 infection as per physician assessment, or close contact (within 1 week) with an individual with confirmed SARS-CoV-2 infection * Any of the following known laboratory evidence of hepatitis virus infection: * Positive results of hepatitis B surface (HBs) antigen * Presence of hepatitis B core (HBc) antibody together with hepatitis B virus DNA (HBV-DNA) * Presence of hepatitis C ribonucleic acid (RNA) * Known human immunodeficiency virus (HIV) infection. Further exclusion criteria apply.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05963867 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Small Cell Lung Carcinoma (SCLC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05963867 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05963867 currently recruiting?
Yes, NCT05963867 is actively recruiting participants. Contact the research team at clintriage.rdg@boehringer-ingelheim.com for enrollment information.
Where is the NCT05963867 trial being conducted?
This trial is being conducted at Amsterdam, Netherlands.
Who is sponsoring the NCT05963867 clinical trial?
NCT05963867 is sponsored by Boehringer Ingelheim. The trial plans to enroll 12 participants.