Small Cell Lung Carcinoma (SCLC)Phase 1NCT05963867
A Study to Test How BI 764532 is Taken up by Tumours in People With Small-cell Lung Cancer or Neuroendocrine Cancer
A Phase 1 study testing BI 764532 and [89Zr]Zr-BI 764532 in people with Small Cell Lung Carcinoma (SCLC) and Neuroendocrine Neoplasms, run by Boehringer Ingelheim at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Carcinoma (SCLC), Neuroendocrine Neoplasms
- What is being tested?
- BI 764532 and [89Zr]Zr-BI 764532
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- 6 Aug 2024to 15 Jan 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- 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
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam UMC Locatie VUMC
Amsterdam, 1081HV
Boehringer Ingelheim, 08000204613, nederland@bitrialsupport.com
About this study
Official title: An Open-label Phase 1 PET Imaging Trial to Investigate [89Zr]Zr-BI 764532 Biodistribution and Tumour Uptake in Patients With Small-cell Lung Carcinoma or Neuroendocrine Carcinoma
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.
- Being tested
- BI 764532, [89Zr]Zr-BI 764532
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 764532Drug
Also called Obrixtamig
BI 764532
[89Zr]Zr-BI 764532Drug
[89Zr]Zr-BI 764532
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Not described Receives: Drug: BI 764532; Drug: [89Zr]Zr-BI 764532 |
| Cohort 2 | Experimental | Not described Receives: Drug: BI 764532; Drug: [89Zr]Zr-BI 764532 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean relative change from baseline of [89Zr]Zr-BI 764532 tumour-to-plasma ratios in all detectable lesions post BI 764532 doses
Measured: at baseline and up to 35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start6 Aug 2024
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung Carcinoma (SCLC)Studies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05963867
- Sponsor's protocol ID
- 1438-0004
- Status last verified
- Oct 2026
- First submitted
- 18 Jul 2023
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Phase 1 PET Imaging Trial to Investigate [89Zr]Zr-BI 764532 Biodistribution and Tumour Uptake in Patients With Small-cell Lung Carcinoma or Neuroendocrine Carcinoma
- ClinicalTrials.gov ID
- NCT05963867
- Acronym / sponsor ID
- 1438-0004
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 6 Aug 2024 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: BI 764532, Drug: [89Zr]Zr-BI 764532 |
| Cohort 2 | Experimental | Drug: BI 764532, Drug: [89Zr]Zr-BI 764532 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (15 listed)
- Previous or concomitant malignancies other than the one treated in this trial within the last 2 years except:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BI 764532Also: ObrixtamigBI 764532 | Drug | Cohort 1, Cohort 2 |
| [89Zr]Zr-BI 764532[89Zr]Zr-BI 764532 | Drug | Cohort 1, Cohort 2 |
Primary outcome
Mean relative change from baseline of [89Zr]Zr-BI 764532 tumour-to-plasma ratios in all detectable lesions post BI 764532 doses
Time frame: at baseline and up to 35 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BI 764532 and [89Zr]Zr-BI 764532 in people with Small Cell Lung Carcinoma (SCLC) and Neuroendocrine Neoplasms, run by Boehringer Ingelheim at 1 site in Netherlands.
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 10 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Boehringer Ingelheim (1-800-243-0127, clintriage.rdg@boehringer-ingelheim.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean relative change from baseline of [89Zr]Zr-BI 764532 tumour-to-plasma ratios in all detectable lesions post BI 764532 doses (time frame: at baseline and up to 35 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Oct 2026.