Studieoverzicht

Study name: A Phase 1/1b Study of IAM1363 in Participants with Advanced Cancers Harboring HER2 Alterations.

Histology	NSCLC, only non-squamous
Tumor stage	Stage III - IV
Host / recruiting site 1	Antoni van Leeuwenhoek	Enrollment	Recruiting
Therapy line	Later line (≥2L)
Design	Phase 1/1b open-label, multi-center study, designed to evaluate IAM1363 in participants with advanced cancers that harbor HER2 alterations. Only PART 2 is open: Monotherapy Dose Optimization
Intervention	IAM1363 is a highly potent and irreversible TKI that selectively targets HER2 and HER2 mutants, including the exon 20 insertion mutations.
Key outcome parameters	Determine recommended dose.
Key inclusion criteria	Progression of disease after last systemic therapy. Calculated creatinine clearance ≥ 60 mL/min HER2 TKD mutation (by NGS, PCR, or Sanger sequencing) from an archival tumor tissue sample analyzed by CLIA-certified or ISO-accredited laboratory. Mutations include: i. HER2/ERBB2 TKD domain covering amino acid sequence from codons 720-993 ii. HER2 gene fusions Received and failed ≥1 prior therapy, which included platinum-based chemotherapy. No prior treatment wiht HER2 TKI
Key exclusion criteria	Brain metastases are allowed, if not requiring immediate local therapy. Uncontrolled hypertension
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