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Contact Information:

AstraZeneca Clinical Study Information Center 1-877-240-9479
information.center@astrazeneca.com


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Be Part of Research - Trial Details - A Phase I/IIa Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of AZD0022 as Monotherapy and in Combination With Anti-cancer Agents in Adult Participants With Tumours Harbouring a KRASG12D Mutation
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A Phase I/IIa Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of AZD0022 as Monotherapy and in Combination With Anti-cancer Agents in Adult Participants With Tumours Harbouring a KRASG12D Mutation

Recruiting

Open to: ALL

Age: 18.0 - N/A

Cambridge Newcastle-Upon-Tyne

Medical Conditions

Adenocarcinoma

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


This is a first-in-human, modular, Phase I/IIa, open-label, multi-centre study to assess the safety, tolerability, PK, and preliminary efficacy of AZD0022 monotherapy in combination with other anti-cancer agents in participants with tumours harbouring a KRASG12D mutation.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Oct 2024 Jan 2028

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : AZD0022 is an oral KRASG12D inhibitor that blocks KRASG12D function in patients with this type of mutation.

Intervention Arm Group : Module 1 Part A. Dose Escalation;Module 1 Part B. Dose Optimisation;Module 1 Part B. Food Effect Cohort;Module 1 Part C. Potential Efficacy Expansion;Module 2 Part A. Dose Escalation;Module 2 Part B. Dose Optimisation;Module 2 Part C. Potential Efficacy Expansion;

Intervention Type : DRUG
Intervention Description : Cetuximab (Erbitux®) is a recombinant chimeric human/mouse Immunoglobulin G monoclonal antibody which binds to EGFR and competitively inhibits the binding of EGFR and other ligands

Intervention Arm Group : Module 2 Part A. Dose Escalation;Module 2 Part B. Dose Optimisation;Module 2 Part C. Potential Efficacy Expansion;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Research Site
    Cambridge
    CB2 0QQ
  • Research Site
    Newcastle-Upon-Tyne
    NE7 7DN

AstraZeneca Clinical Study Information Center 1-877-240-9479
information.center@astrazeneca.com



The study is sponsored by AstraZeneca



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Read full details for Trial ID: NCT06599502
Last updated 14 May 2025

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