First in Human Study of AZD9592 in Solid Tumors

Part of paid clinical trials in Duarte, California.

Sponsor
AstraZeneca
Study ID
NCT05647122
Phase
PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AZD9592 — DRUG
    Varying doses of AZD9592
  • Osimertinib — DRUG
    tablets administered orally
  • 5-Fluorouracil (5-FU) — DRUG
    IV infusion
  • Leucovorin — DRUG
    IV infusion
  • Bevacizumab — DRUG
    IV infusion

Study Details

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.

Key Dates

Start date
Dec 21, 2022
Status verified
Jun 2026
Primary completion
Aug 3, 2028
Completion
Aug 3, 2028

Study Design

Enrollment
167 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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
  • 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)

Primary Outcome Measure

Incidence of Adverse Events (AEs) [ Time Frame: From time of Informed Consent to 30 days post last dose of AZD9592 ]

Locations (15)

FacilityCityStateZIPSite coordinators
Research SiteDuarteCalifornia91010-
Research SiteNorth HavenConnecticut06473-
Research SiteWashington D.C.District of Columbia20016-
Research SiteChicagoIllinois60637-
Research SiteBaltimoreMaryland21224-
Research SiteBaltimoreMaryland21231-
Research SiteMilfordMassachusetts01757-
Research SiteMineolaNew York11501-
Research SiteNew YorkNew York10016-
Research SiteNew YorkNew York10021-
Research SiteNew YorkNew York10029-
Research SitePhiladelphiaPennsylvania19104-
Research SiteProvidenceRhode Island02903-
Research SiteHoustonTexas77030-
Research SiteFairfaxVirginia22031-

Find similar trials in Duarte, CA

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Research Site· Duarte, CAResearch Site· North Haven, CTResearch Site· Washington D.C., DCResearch Site· Chicago, ILResearch Site· Baltimore, MDResearch Site· Milford, MA

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