Studieoverzicht

Study name: A Phase 1/2a, Open-label, Dose-finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BMS-986507 (BL-B01D1) combinations in Adult Participants with Advanced Solid Tumors. (M24BBL)

Histology NSCLC, all subtypes
Tumor stage Stage III - IV
Host / recruiting site 1 Antoni van Leeuwenhoek Enrollment Recruiting
Therapy line First line (1L) ,  Later line (≥2L)
Design

Multicenter, open-label, Phase 1/2a study to evaluate the safety, tolerability, PK, preliminary efficacy and the optimal dose of BMS-986507 in combination with SoC treatments for participants with locally advanced or metastatic EGFRmt NSCLC and EGFRwt NSCLC
Group A: first line EGFRmt NSCLC (dose expansion)
Group B: >lines EGFRwt NSCLC (dose escalation and dose expansion)

Intervention

Group A: BMS-986507 (ADC (antibody drug conjugate) bestaande uit een bispecifieke EGFR x HER3 IgG1 antibody met een topoisomerase1 payload) + osimertinib
Group B: BMS-986507 (ADC (antibody drug conjugate) bestaande uit een bispecifieke EGFR x HER3 IgG1 antibody met een topoisomerase1 payload) + pembrolizumab

Key outcome parameters

Safety, tolerability, PK, preliminary efficacy and the optimal dose of BMS-986507 in combination with SoC treatments.

Key inclusion criteria

Group A:

  • pathologically confirmed locally advanced or metastatic NSCLC with an EGFR exon 19 deletion or L858R mutation in exon 21, either alone or in combination with other EGFR mutations, which may include T790M in exon 20. Participants with other EGFR mutations (including but not limited to, exon 21 L861Q, exon 18 G719X, and exon 20 S768I mutations, etc.) will also be allowed.
  • First line

Group B:

  • Pathologically confirmed locally advanced or metastatic NSCLC
Key exclusion criteria
  • Known EGFR exon 20 insertion will be excluded (Group A)
  • Known mutations in EGFR will be excluded (Group B)
  • Symptomatic central nervous system (CNS) metastases. progression of existing CNS metastases, or the appearance of new lesions as shown on CNS imaging during screening will be excluded
  • Active autoimmune diseases and inflammatory diseases
  • History of severe heart disease (myocardial infarction/stroke/TIA < 6 months)
Contact information