Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Colorectal Neoplasms

Head and Neck Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Amino Acids

Osimertinib

Antibodies

Bevacizumab

Leucovorin

Fluorouracil

Immunoglobulins

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Antidotes

Protective Agents

Folic Acid

Vitamin B Complex

Trace Elements

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Folate

Vitamin B9

Tyrosine

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

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)

AZD9592

5-Fluorouracil (5-FU)

AstraZeneca Clinical Study Information Center

Charu Aggarwal, MD, MPH

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.

First in Human Study of AZD9592 in Solid Tumors

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

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared

Number of patients with adverse events by system organ class and preferred term

Number of patients with serious adverse events by system organ class and preferred term

Number of patients with at least 1 dose-limiting toxicity (DLT), which is any toxicity defined as a DLT in the Clinical Study Protocol

measured by laboratory and vital sign variables over time including change from baseline

Assessed by overall response rate (ORR) defined as the proportion of patients who have a confirmed complete or partial radiological response by the Investigator according to RECIST v1.1 (for patients in the dose expansion cohorts, only)

The percentage or number of patients with a confirmed investigator assessed complete or partial response according to response criteria in solid tumours (RECIST v1.1)

The time from date of first response until date of disease progression or last evaluable assessment (RECIST v1.1) in the absence of progression

The percentage of patients with confirmed CR or PR or having SD maintained (RECIST v1.1) for \>=11 weeks from first dose

The time from first dose until RECIST 1.1 defined disease progression or death due to any cause

The time from the date of the first dose of study treatment until death due to any cause.

Measurement of plasma concentrations of AZD9592, total antibody and total unconjugated warhead

Measurement of PK parameters: Area under the concentration time curve (AUC)

Measurement of PK parameters: Maximum observed plasma concentration of the study drug (C-max)

Measurement of PK parameters: Time to maximum observed plasma concentration of the study drug (T-max)

Measurement of PK parameters: the volume of plasma from which the study drug is completely removed per unit time (Clearance)

Measurement of PK parameters: Terminal elimination half-life (t 1/2)

Evaluating the number and percentage of patients who develop Anti-drug antibody (ADA) during treatment

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
First in Human Study of AZD9592 in Solid Tumors	NCT05647122	Advanced Solid ... Carcinoma Non-s... Head and Neck N... Colorectal Neop...	AZD9592 Osimertinib 5-Fluorouracil ... Leucovorin Bevacizumab	18 Years -	AstraZeneca
First in Human Study of AZD9592 in Solid Tumors	NCT05647122	Advanced Solid ... Carcinoma Non-s... Head and Neck N... Colorectal Neop...	AZD9592 Osimertinib 5-Fluorouracil ... Leucovorin Bevacizumab	18 Years -	AstraZeneca
First in Human Study of AZD9592 in Solid Tumors	NCT05647122	Advanced Solid ... Carcinoma Non-s... Head and Neck N... Colorectal Neop...	AZD9592 Osimertinib 5-Fluorouracil ... Leucovorin Bevacizumab	18 Years -	AstraZeneca

Spots Global Cancer Trial Database for azd9592

Every month we try and update this database with for azd9592 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for azd9592

Every month we try and update this database with for azd9592 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for azd9592 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.