Studieoverzicht

Study name: A Phase I/IIa Multi-center, Open-label Master Protocol Dose Escalation and Expansion Study of AZD8205 as Monotherapy and in Combination with Anticancer Agents in Participants with Advanced Solid Tumors (BLUESTAR). (M23ABD)

Histology	NSCLC, only squamous
Tumor stage	Stage III - IV
Host / recruiting site 1	Antoni van Leeuwenhoek	Enrollment	Recruiting
Therapy line	Later line (≥2L)
PD-L1 expression	Negative: <1% , Low: 1 - 49% , High: ≥50%
Design	Explore the safety and tolerability of AZD8205 as a monotherapy and to evaluate the antitumor activity of AZD8205 in breast, ovarian, endometrial, biliary tract and squamous non-small cell lung cancers.
Intervention	AZD8205 will be administered intravenously (IV) every 3 weeks (Q3W)
Key outcome parameters	Safety and tolerability of AZD8205 as a monotherapy
Key inclusion criteria	Pre-screening process: baseline tissue sample for B7-H4 analysis At least 1 prior systemic line of therapy Progressed on SoC including approved targeted therapy Wildtype for targetable driver mutation must have progressed on platinum-containing regimen and immune checkpoint blockade.
Key exclusion criteria	Brain metastases unless treated or asymptomatic Uncontrolled hypertension Significant cardiovascular event within 6 months
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