Study identifier:D9350C00001
ClinicalTrials.gov identifier:NCT05647122
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase I, Multicenter, Open-label, First-in-Human, Dose Escalation and Expansion Study of AZD9592 as Monotherapy and in Combination with Anti-cancer Agents in Patients with Advanced Solid Tumors
Advanced Solid Tumours
Phase 1
No
AZD9592, Osimertinib
All
108
Interventional
18 Years - n/a
Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Feb 2023 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Module 1 AZD9592 Monotherapy Module 1 has two parts: Part A aims to determine the safety, tolerability, maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of AZD9592. Part B aims to determine the safety, tolerability and evaluate anti-tumor activity of AZD9592 as monotherapy in select solid tumors | Drug: AZD9592 Varying doses of AZD9592 |
Experimental: Module 2 AZD9592 Combination with Osimertinib Module 2 has two parts: Part A aims to determine the safety, tolerability, maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of AZD9592 in combination with Osimertinib. Part B aims to determine the safety, tolerability and evaluate anti-tumor activity of AZD9592 in combination with Osimertinib in NSCLC EGFRm | Drug: AZD9592 Varying doses of AZD9592 Drug: Osimertinib tablets administered orally |