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
Status: Recruiting
Location: See all (50) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
This is a first-in-human (FIH) Phase I, multi-center, open-label, study of AZD9592, in patients with advanced solid tumors. The study consists of several study modules, each evaluating the safety, tolerability, preliminary efficacy, pharmacokinetics (PK), pharmacodynamics, anti-tumor activity, and immunogenicity of AZD9592, as monotherapy or in combination with anti-cancer agents.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age ≥ 18 years
• Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1
• Life expectancy ≥ 12 weeks
• Measurable disease per RECIST v1.1
• Adequate organ and marrow function as defined in the protocol
⁃ Additional Inclusion Criteria for Module 1:
⁃ • Histologically or cytologically confirmed metastatic or locally advanced EGFRmut., NSCLC; metastatic EGFRwt. NSCLC; recurrent or metastatic HNSCC of the oral cavity; metastatic CRC.
⁃ Additional Inclusion Criteria for Module 2:
⁃ • Histologically or cytologically confirmed metastatic NSCLC EGFRmut.
⁃ Additional Inclusion Criteria for Module 3:
⁃ • Histologically or cytologically confirmed metastatic CRC.
Locations
United States
California
Research Site
RECRUITING
Duarte
Research Site
WITHDRAWN
Irvine
Connecticut
Research Site
RECRUITING
North Haven
Washington, D.c.
Research Site
RECRUITING
Washington D.c.
Illinois
Research Site
RECRUITING
Chicago
Massachusetts
Research Site
RECRUITING
Milford
Maryland
Research Site
RECRUITING
Baltimore
Research Site
RECRUITING
Baltimore
New York
Research Site
RECRUITING
Mineola
Research Site
RECRUITING
New York
Research Site
RECRUITING
New York
Research Site
RECRUITING
New York
Pennsylvania
Research Site
RECRUITING
Philadelphia
Rhode Island
Research Site
RECRUITING
Providence
Texas
Research Site
RECRUITING
Houston
Virginia
Research Site
RECRUITING
Fairfax
Other Locations
Australia
Research Site
RECRUITING
Kogarah
Research Site
RECRUITING
Melbourne
Canada
Research Site
RECRUITING
Edmonton
Research Site
RECRUITING
Toronto
China
Research Site
NOT_YET_RECRUITING
Beijing
Research Site
RECRUITING
Beijing
Research Site
RECRUITING
Chongqing
Research Site
RECRUITING
Guangzhou
Research Site
NOT_YET_RECRUITING
Harbin
Research Site
RECRUITING
Wuhan
France
Research Site
RECRUITING
Marseille
Research Site
RECRUITING
Rennes
Research Site
RECRUITING
Villejuif
Italy
Research Site
RECRUITING
Milan
Research Site
RECRUITING
Orbassano
Research Site
RECRUITING
Rozzano
Research Site
RECRUITING
Verona
Japan
Research Site
RECRUITING
Chūōku
Research Site
RECRUITING
Kashiwa
Research Site
NOT_YET_RECRUITING
Kōtoku
Research Site
NOT_YET_RECRUITING
Osaka
Malaysia
Research Site
NOT_YET_RECRUITING
Kuala Lumpur
Research Site
RECRUITING
Kuching
Republic of Korea
Research Site
RECRUITING
Seoul
Research Site
RECRUITING
Seoul
Research Site
RECRUITING
Seoul
Research Site
RECRUITING
Seoul
Spain
Research Site
RECRUITING
Barcelona
Research Site
RECRUITING
Madrid
Research Site
RECRUITING
Seville
Taiwan
Research Site
RECRUITING
Taichung
Research Site
RECRUITING
Taipei
Research Site
RECRUITING
Taipei
Research Site
RECRUITING
Taoyuan District
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date:2022-12-22
Estimated Completion Date:2027-10-06
Participants
Target number of participants:403
Treatments
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
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
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)