CI

At a glance

ClinicalIndex Comparison Record
Phase 1Active· 167 enrolled / 167 target
Drug / intervention
AZD9592 +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05647122
NCT05647122Phase 1ActiveHigh Momentum (3.9/mo)
CompareCT.gov

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

AstraZeneca·interventional·Posted Dec 12, 2022·Updated Jun 11, 2026

In Brief

A Phase 1 clinical trial evaluating AZD9592, Osimertinib, and 3 other interventions for Advanced Solid Tumours and 3 related conditions. Active but no longer recruiting, targeting 167 participants across 46 sites in 11 countries.

Signals

Enrolling ahead of pace

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Solid Tumours, Carcinoma Non-small Cell Lung, Head and Neck Neoplasms, Colorectal Neoplasms
CountriesAustralia, Canada, China, France, Italy, Japan, Malaysia, South Korea, Spain, Taiwan, United States
Collaborators--

Timeline

Phase 1Active
202320242025202620272028
First PostedDec 12, 2022
Enrollment StartDec 21, 2022
Primary CompletionAug 3, 2028
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 3.6 years agoPrimary completion in 2.1 years

Arms & Interventions

Module 1 AZD9592 Monotherapyexperimental

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
Module 2 AZD9592 Combination with Osimertinibexperimental

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: AZD9592Drug: Osimertinib
Module 3 AZD9592 Combination 5-FU, Bevacizumab, Leucovorinexperimental

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: AZD9592Drug: 5-Fluorouracil (5-FU)Drug: LeucovorinDrug: Bevacizumab

Interventions

AZD9592drug

Varying doses of AZD9592

Osimertinibdrug

tablets administered orally

5-Fluorouracil (5-FU)drug

IV infusion

Leucovorindrug

IV infusion

Bevacizumabdrug

IV infusion