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A Study to Test Different Doses of BI 764532 in Patients With Small Cell Lung Cancer and Other Neuroendocrine Tumours That Are Positive for Delta-Like Ligand 3 (DLL3).

Status
Active
Cancer Type
Lung Cancer
Trial Phase
Phase I
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT04429087
Protocol IDs
1438-0001 (primary)
NCI-2021-01392
2019-000729-31
Study Sponsor
Boehringer Ingelheim Pharmaceuticals Inc

Summary

To determine the maximum tolerated dose(s) (MTD) or the Recommended Dose for Expansion (RDE)
and dosing regimen for further development of BI 764532. The MTDs will be defined based on
the frequency of patients experiencing dose limiting toxicities (DLTs) during the MTD
evaluation period in studied regimens. The RDE will be guided by overall safety, efficacy,
Pharmacokinetics (PK) and Pharmacodynamics (PD) assessments.

Additional objectives are to document the safety and tolerability of BI 764532, to
characterise pharmacokinetics and pharmacodynamics, and to evaluate efficacy signals.

Phase Ib will further explore BI 764532 in selected patients populations based on data from
phase Ia.

The Phase Ib objectives, endpoints and design will be specified in a study protocol amendment
after availability of phase Ia results.

Eligibility

  1. Signed and dated, written informed consent form (ICF2) in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) - Good Clinical Practice (GCP) and local legislation prior to any trial-specific procedures, sampling, or analyses.
  2. Locally advanced or metastatic cancer not amenable to curative treatment; of following histologies:
  3. Small cell lung carcinoma (SCLC)
  4. Large cells neuroendocrine lung carcinoma(LCNEC)
  5. Neuroendocrine carcinoma (NEC) or small cell carcinoma of any other origin
  6. Tumours must be positive for DLL3 expression (on archived tissue or instudy fresh biopsy) according to central pathology review in order to start BI 764532
  7. Patients with tumours with mixed histologies for any above type are eligible only if neuroendocrine carcinoma/small tumor cells component is predominant and represent at least 50% of the overall tumour tissue.
  8. For back-fill cohorts only: patient has agreed to and signed an IC to provide mandatory pre-treatment and on-treatment fresh tumor biopsy.
  9. Patient has failed or is not eligible for available standard therapies according to local guidelines. Standard therapies should include at least one line of chemotherapy that should include platinum for patients with small cells carcinoma tumors histologies.
  10. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  11. At least one evaluable lesion outside of CNS as defined per modified Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
  12. Subjects with brain metastases are eligible provided they meet the following criteria:
  13. Radiotherapy or surgery for brain metastases was completed at least 2 weeks prior to the first administration of BI 764532
  14. 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 Central Nervous System (CNS) disease.
  15. Adequate liver, bone marrow and renal organ function Futher inclusion criteria apply
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