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For Healthcare Professionals

About the Dareon™-5 Trial

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Trial Overview

The DareonTM-5 trial is a phase 2, dose-selection study that will enroll 120 patients. After screening, eligible patients will be randomized to receive either a high (Arm A) or a low (Arm B) dose of BI 764532. 

BI 764532 will be administered intravenously in 21-day cycles.

Trial Objective

The purpose of this study is to evaluate the safety and efficacy of 2 dose levels of BI 764532 monotherapy in patients with relapsed/refractory SCLC, after at least 2 prior lines of therapy including at least 1 platinum-based regimen, and in patients with relapsed/refractory NECs following at least 1 platinum-based regimen. 

BI 764532 is a novel IgG-like T cell engager with two monovalent binding arms, one of which binds to DLL3 on the surface of cancer cells and the other binds to CD3 on T cells. BI 764532 functions as a bridge between tumor cells and cytolytic T cells, directing the cytolytic activity of T cells selectively to the DLL3-expressing tumor cells. This may induce the formation of a cytolytic synapse between the T cells and tumor cells resulting in apoptosis of the target cells and subsequent activation of T cells and an inflammatory environment in the tumor tissue. 

The primary outcomes of the DareonTM-5 trial are objective response (OR) and the occurrence of treatment-emergent adverse events (TEAEs) during the on-treatment period. Secondary outcomes of the trial include the duration of OR, progression-free survival, disease control, overall survival, patient-reported outcomes, and occurrence of TEAEs leading to study drug discontinuation during the on-treatment period.

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Trial Duration

Treatment in the DareonTM-5 trial will continue until patient’s disease progresses, or until another reason requiring termination of treatment occurs, such as undue toxicity or patient decision. Following disease progression, a patient may continue to receive treatment if based on the Investigator’s medical judgement the patient is deriving a clinical benefit. Treatment duration should not exceed 36 months. 

All patients will perform an End of Treatment visit as soon as the decision to end trial treatment has been taken and a safety follow-up visit 30-35 days after receiving the last dose of BI 764532. Patients who ended treatment for reasons other than progressive disease will continue tumor assessments until documented disease progression or start of a new anti-cancer therapy.

Key Eligibility Criteria

Patients in the DareonTM-5 trial must be 18 years of age or older with:

  • Histologically or cytologically confirmed, relapsed/refractory SCLC, after ≥2 prior lines of therapy including at least one platinum-based regimen

  • Or histologically or cytologically confirmed, relapsed/refractory extra-pulmonary NECs (excluding Merkel cell carcinoma, medullary thyroid cancer, and neuroendocrine prostate cancer) or large cell NEC of the lung, after ≥1 prior line of therapy including at least one platinum-based regimen

  • ECOG PS 0–1

  • ≥1 measurable lesion per RECIST v1.1 within 21 days prior to the first dose of BI 764532

  • Availability of archival tumor tissue samples

  • Adequate organ function

  • No untreated or symptomatic brain metastases, leptomeningeal disease, or prior DLL3-targeting therapy

Pipeline compound(s) are under pre-clinical and/or clinical investigation and have not been approved by regulatory authorities for commercial use in patients. Efficacy and safety have not been established and there is no guarantee that they will become commercially available for the use(s) under investigation. 

MOA data are based on in vitro/in vivo data and the clinical significance have not been established.