DAREON®-36: A Study to Test Obrixtamig in Combination With ZL-1310 in People With Advanced Small Cell Lung Cancer or Other Neuroendocrine Cancers
A Phase Ib/II, Open-label, Safety and Tolerability Trial of Obrixtamig in Combination With ZL-1310 in Patients With Poorly Differentiated NEC
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Infusions
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "All study treatments are given as infusions into a vein."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests obrixtamig and ZL-1310 in adults with advanced small cell lung cancer or certain other neuroendocrine cancers. Part 1 looks for a suitable dose, while Part 2 tests how well people tolerate these drugs with another medicine called a checkpoint inhibitor and is only for small cell lung cancer. The study also checks whether treatment can stop cancer from growing.
This study is open to adults with advanced small cell lung cancer and other neuroendocrine cancers. The study has 2 parts. The purpose of Part 1 is to find a suitable dose of a combination study treatment, obrixtamig and ZL-1310. The purpose of Part 2 is to see how obrixtamig and ZL-1310 is tolerated when given with another medicine called a checkpoint inhibitor. Another purpose is to check whether the study treatment can stop the cancer from growing and keep it stable. Obrixtamig and ZL-1310 are being developed to help the immune system fight cancer. In Part 1, participants get obrixtamig and ZL-1310. In Part 2, participants get obrixtamig and ZL-1310 with a checkpoint inhibitor. Part 2 is only open to people with advanced small cell lung cancer. All study treatments are given as infusions into a vein. The study does not have a fixed duration. Participants can receive study treatment for up to 2 years if they benefit from treatment and can tolerate it. Participants visit the study site regularly, with some overnight stays required. During this time, doctors regularly check for health problems that could be caused by the study treatment. They also monitor the size of the tumour(s) and take laboratory tests.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be at least 18 and old enough to legally agree to join in your country. Sign a consent form before any study tests.
- Be able and willing to follow study instructions, visits, treatments, tests, and other rules.
- Part 1: Have small cell lung cancer, large cell neuroendocrine lung cancer, or small or large cell neuroendocrine cancer outside the lungs. The cancer must have spread nearby, spread farther, or come back.
- Part 1: If the tumor has mixed cancer types, at least half must be the neuroendocrine or small cell type.
- Part 1: Have no proven treatment options left or be unable to use them. You must have had platinum-based chemotherapy unless there is a documented medical reason not to.
- Part 2: Have small cell lung cancer that has spread widely, confirmed by tissue or cell testing, with no mixed cancer types.
- Part 2: Have had no whole-body treatment for this widely spread cancer. Prior chemotherapy and radiation for limited-stage disease must have aimed to cure it and ended at least 6 months before the widely spread cancer was diagnosed.
- Other entry rules apply.
Who can't join
- A serious illness, mental health condition, substance use disorder, open sore, or abnormal test result that could make the study unsafe or affect participation or results.
- Merkel cell cancer, medullary thyroid cancer, or cancer in the layers covering the brain and spinal cord.
- An allergy to a study drug or its ingredients, a past life-threatening reaction to antibody medicines, or a major risk of a serious allergic reaction.
- A severe immune-system side effect or infusion reaction that led you to permanently stop a cancer treatment that works through the immune system.
- Side effects from past treatment that are still more than mild. Some exceptions apply, including certain stable side effects.
- Any past treatment targeting DLL3, or more than 30 Gy of radiation to the chest. Gy is a unit used to measure radiation dose.
- A past organ or tissue transplant from another person.
- Other rules may keep you from joining.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion criteria: For Part 1 1. Diagnosed with locally advanced, metastatic or relapsed cancer of the following histologies: * Small cell lung carcinoma (SCLC) * Large cell neuroendocrine lung carcinoma (LCNEC-L) * Extrapulmonary neuroendocrine carcinoma (epNEC) of small or large cell histology 2. Patients with tumours with mixed histologies for any above type are eligible only if the neuroendocrine carcinoma/small cell component is predominant and represents at least 50% of the overall tumour tissue 3. Patients for whom no therapy of proven efficacy exists or who are not eligible for established treatment options. Patients 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, unless there is a documented medical reason not to use platinum For Part 2 4. Histologically or cytologically confirmed extended stage small cell lung cancer (ES-SCLC) (excluding combined histologies) using the American Joint Committee on Cancer (AJCC) tumour node metastasis staging system combined with Veterans Administration Lung Study Group (VALG)'s two stage classification scheme. 5. Patients must have received no prior systemic therapy for ES-SCLC. Participants with prior chemoradiotherapy for Limited stage small cell lung cancer (LS-SCLC) must have been treated with curative intent and had a treatment-free interval of at least 6 months after the last chemotherapy, radiotherapy, or chemoradiotherapy before diagnosis of ES-SCLC to be eligible For both Part 1 and Part 2 6. Signed and dated written informed consent in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) and local legislation prior to any trial-specific procedures, sampling, or analyses 7. 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) 8. Willing and able to comply with scheduled visits, treatment schedule, the planned trial assessments, laboratory tests, restrictions regarding prohibited medications, lifestyle restrictions, and other requirements related to the trial. This includes that they are able to understand and follow trial-related instructions 9. Further inclusion criteria apply. Exclusion criteria: 1. Serious concomitant disease or medical condition such as neurologic, psychiatric (including substance use disorder), active ulcers (gastrointestinal tract or skin) or laboratory abnormalities that may negatively impact patient safety during trial participation, affect compliance with trial requirements or invalidate assessments relevant for the investigation of the safety and preliminary efficacy of the investigational drugs 2. Patients with a diagnosis of Merkel cell carcinoma or medullary thyroid cancer 3. Presence of leptomeningeal disease and/or carcinomatous meningitis 4. Known hypersensitivity to the trial drugs or their excipients, prior severe, life-threatening hypersensitivity reaction(s) to monoclonal antibodies, or significant risk of allergic or anaphylactic reaction(s) to any of the investigated drug products according to the investigator's judgement 5. Participants who experienced severe, life-threatening immune-mediated adverse events, e.g. serious Grade 3 or higher immune-related adverse event (imAE) or infusion-related reactions, that led to permanent discontinuation while on treatment with immuno-oncology agents 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, amenorrhea/menstrual disorders, CTCAE Grade 2 peripheral neuropathy, and CTCAE Grade 2 endocrinopathies controlled by replacement therapy, and toxicities, which are considered irreversible but stable for at least 4 weeks, per investigator judgment) 7. Therapy with any of the following types of treatments or drugs within the noted time intervals prior to IMP administration: At any time: treatment with delta-like ligand 3 (DLL3)-targeting therapies or received more than 30 Gy of thoracic radiotherapy. 8. Prior organ or tissue allograft 9. Further exclusion criteria apply.
Study sites (4)
DC
- MedStar Georgetown University Hospital · Washington D.C., DC 20007Boehringer Ingelheim · Study contact · 833-602-2368 · unitedstates@bitrialsupport.comMore trials in Washington D.C.
FL
- H. Lee Moffitt Cancer Center and Research Institute · Tampa, FL 33612Boehringer Ingelheim · Study contact · 833-602-2368 · unitedstates@bitrialsupport.comMore trials in Tampa
IL
- Northwestern University · Chicago, IL 60611Boehringer Ingelheim · Study contact · 833-602-2368 · unitedstates@bitrialsupport.comMore trials in Chicago
KY
- University of Kentucky Medical Center · Lexington, KY 40536Boehringer Ingelheim · Study contact · 833-602-2368 · unitedstates@bitrialsupport.comMore trials in Lexington