First in Human Study of AZD9592 in solid tumors - EGRET
Study identifier:D9350C00001
ClinicalTrials.gov identifier:NCT05647122
EudraCT identifier:N/A
CTIS identifier:2022-501570-18-00
Recruiting
Official Title
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
Medical condition
Advanced Solid Tumours
Phase
Phase 1
Healthy volunteers
No
Study drug
AZD9592, Osimertinib, 5-Fluorouracil (5-FU), Leucovorin, Bevacizumab
Sex
All
Estimated Enrollment
162
Study type
Interventional
Age
18 Years - n/a
Date
Study Start Date: 22 Dec 2022
Estimated Primary Completion Date: 29 Oct 2025
Estimated Study Completion Date: 29 Oct 2025
Study design
Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verification:
Verified 01 Apr 2024 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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| 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 |
| Experimental: Module 3 AZD9592 Combination 5-FU, Bevacizumab, Leucovorin Module 3 has two parts: Part A aims to determine the safety, tolerability and/or recommended phase 2 dose (RP2D) of AZD9592 in combination with 5-FU, Bevacizumab, Leucovorin in Colorectal Cancer (CRC) Part B aims to determine the safety, tolerability and evaluate anti-tumor activity of AZD9592 in combination with 5-FU, Bevacizumab, Leucovorin in Colorectal Cancer (CRC) | Drug: AZD9592 Varying doses of AZD9592 Drug: 5-Fluorouracil (5-FU) IV infusion Drug: Leucovorin IV infusion Drug: Bevacizumab IV infusion |
Contacts
Investigators
Principal Investigator
Charu Aggarwal
University of Pennsylvania
