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Studieoverzicht

Study name: CA2440001: 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 LUMC Enrollment Recruiting
Host / recruiting site 2 Antoni van Leeuwenhoek Enrollment Recruiting
Therapy line First line (1L) ,  Later line (≥2L)
Design

A Phase 1/2a, Open-label, Dose-finding Study
Intervention

BMS-986507, bispecific EGFR×HER3 IgG1 ADC
Group A combination with Osimertinib
Group B combination with (platinum based chemotherapy) and Pembrolizumab
Key outcome parameters

Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy
Key inclusion criteria

Group A: EGFRmt NSCLC, no prior systemic cancer therapy including tyrosine kinases inhibitors
Group B: EGFRwt NSCLC. Dose expansion second or later line (including AGA other than EGFR)
Dose exploration, no prior systemic cancer therapy
Key exclusion criteria
  • Symptomatic CNS metastases or leptomeningeal metastases
  • history of prior malignancy active within 2 years prior to treatment assignment
  • requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) within 14 days or other immunosuppressive medications within 30 days of treatment assignment.
  • ILD, serious recurrent infections, active autoimmune diseases, history of severe heart disease, poorly controlled hypertension by 2 kinds of antihypertensive drugs
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