Clinical Trial 23066

• Overview

  Study Title:

  An Open-Label, Multi-Center Phase II Dose Selection Trial of Intravenous BI 764532, a DLL3-Targeting T Cell Engager, in Patients with Relapsed/Refractory Extensive-Stage Small Cell Lung Cancer and in Patients with Other Relapsed/Refractory Neuroendocrine Carcinoma DAREON-5

  Objective:

  The primary objective of this trial is to evaluate safety and efficacy of two dose levels of BI 764532 monotherapy in patients with SCLC who have had progression or recurrence following at least two prior lines of therapy, including at least one platinum-based regimen and in patients with histologically or cytologically confirmed advanced or metastatic epNEC (excluding MCC, MTC and NEPC) or LCNEC of the lung as defined by the 2022 WHO classification of Neuroendocrine Neoplasms, that has progressed or recurred following at least one platinum-based regimen. The secondary objective is to further evaluate the efficacy of BI 764532 monotherapy; explore the effect of BI 764532 on core patient-reported outcomes (PROs); further assess the safety and tolerability of BI 764532 monotherapy.

• Treatments

  Therapies:

  Therapy (NOS)

  Medications:

  BI 764532 ()

• Inclusion Criteria

  Key Inclusion Criteria:
  • 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 ICH-GCP and local legislation prior to admission to the trial.
  • Histologically or cytologically confirmed, cancer of the following histology defined in the protocol.
  • Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.
  • Measurable lesions as defined per RECIST v 1.1 within 21 days prior to the first dose of BI 764532.
  • Availability of archival tumour tissue sample.
  • Adequate organ function as defined by the protocol.
  • All toxicities related to previous anti-cancer therapies have resolved ≤ CTCAE Grade 1 prior to trial treatment administration (except for alopecia, peripheral neuropathy, fatigue and endocrinopathies controlled by replacement therapy which must be ≤ CTCAE Grade 2 and amenorrhea/menstrual disorders which can be any grade).
  • Women of childbearing potential (WOCBP) 2 and men able to father a child must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria and instructions on the duration of their use is provided in the participant information.
  • Other inclusion criteria may apply.

• Exclusion Criteria

  Key Exclusion Criteria:
  • Untreated or symptomatic brain metastases.
  • Presence of leptomeningeal disease.
  • Active/previous history of interstitial lung disease or non-infectious pneumonitis (any grade).
  • Participants who experienced severe, life-threatening immune-mediated adverse events or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immuno-oncology agents.
  • Prior anti-cancer therapy: 1) Patients who have been treated with any other anti-cancer drug within 4 weeks or within 5 half-life periods (whichever is shorter) prior to first administration of BI 764532. 2) Patients who have been treated with extensive field radiotherapy including whole brain irradiation within 2 weeks prior to first administration of BI 764532.
  • Previous treatment with DLL3-targeting T cell engagers or cell therapies.
  • Diagnosis of immunodeficiency or systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of BI 764532. Physiological replacement of steroids is allowed.
  • Unresolved toxicity from prior anti-tumour therapy, defined as per protocol.
  • Major surgery (major according to the investigator’s assessment) performed within 28 days prior to randomization or planned during treatment period, e.g. hip replacement.
  • Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening (other than the target indication), except for appropriately treated basal cell carcinoma of the skin or in situ carcinoma of uterine cervix.
  • Presence of any infection requiring systemic antimicrobial treatment within 7 days prior to first dose of trial medication. Patients who have any clinical signs of infection, fever, or leukocytosis, within 48 h prior to first dose of trial medication are not eligible.
  • Laboratory evidence of hepatitis virus infection as defined in the protocol.
  • Patients with known history of HIV infection who meet one or more of the following criteria defined in the protocol.
  • Known hypersensitivity to the trial drugs or their excipients or risk of allergic or anaphylactic reaction to drug product according to Investigator judgement (e.g. patient with history of anaphylactic reaction or autoimmune disease that is not controlled by nonsteroidal anti-inflammatory drugs (NSAIDs), inhaled corticosteroids, or the equivalent of ≤10 mg/day prednisone).
  • Significant cardiovascular/cerebrovascular diseases (e.g. uncontrolled hypertension, unstable angina, history of infarction within past 6 months, congestive heart failure
  • NYHA II).
  • Mean resting corrected QT interval (QTcF) >470 msec in females or >450 msec in males.
  • Participants who must or wish to continue the intake of restricted medications (see Section 4.2.2.1 or any drug considered likely to interfere with the safe conduct of the trial.
  • Participants not expected to comply with the protocol requirements or not expected to complete the trial as scheduled (e.g. chronic alcohol or drug abuse or any other condition that, in the investigator’s opinion, makes the participant an unreliable trial participant).
  • Previous treatment in this trial.
  • Currently enrolled in another investigational device or drug trial, or less than 30 days since receiving other investigational treatment(s).
  • Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
  • Female trial participants planning to donate eggs and male trial participants unwilling to abstain from donating sperm while on trial medication and for at least 35 days after last trial drug administration.
  • Acute or chronic active Epstein-Barr virus (EBV) infection.
  • Other exclusion criteria may apply.

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