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AZD0022 + Cetuximab for Solid Tumors (ALAFOSS-01 Trial)

Phase 1 & 2

Recruiting

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must be ≥ 18 years or the legal age of consent in the jurisdiction at the time of signing the ICF

Participants must have a histologically or cytologically confirmed metastatic or locally advanced tumour

Must not have

Any evidence of clinically significant current or prior ILD

Herbal preparations/medications are not allowed during treatment with study drug

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline, at predefined intervals throughout the administration of azd0022; approximate duration of 2 years.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called AZD0022 on patients with specific tumors that have a KRASG12D mutation. The study aims to evaluate the safety, side effects, how the

Who is the study for?

This trial is for adults with certain cancers (like lung, pancreatic, or colorectal cancer) that have a specific genetic change called KRASG12D mutation. Participants should be able to receive the treatments and follow the study procedures.

What is being tested?

The study is testing AZD0022 alone and combined with other cancer drugs like Cetuximab. It's an early-stage trial to see how safe it is, how the body processes it, and if it works against these cancers.

What are the potential side effects?

Possible side effects include typical reactions from anti-cancer medications such as skin reactions from Cetuximab, fatigue, nausea, and potential risks associated with new drug AZD0022 which are being studied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am at least 18 years old or the legal age of consent.

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My cancer is confirmed to be advanced or has spread.

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My cancer is advanced or has spread, and tests show a KRASG12D mutation.

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I can provide a formalin-fixed, paraffin-embedded tumor sample.

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My cancer did not respond or worsened after standard treatment.

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My cancer has a KRASG12D mutation.

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My NSCLC has progressed after at least one standard treatment.

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My colorectal cancer cannot be cured and has worsened after two standard treatments.

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My pancreatic cancer cannot be cured and has worsened after one standard treatment.

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My colorectal cancer is advanced or has spread, and tests show a KRASG12D mutation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have or had a serious lung condition.

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I am not taking any herbal medications.

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I have been treated with a KRAS inhibitor before.

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I do not have any severe or uncontrolled medical conditions.

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I do not have spinal cord compression, leptomeningeal disease, or active brain metastases.

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I have received an organ transplant from another person.

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I do not have significant heart issues like recent heart attacks or abnormal heart rhythms.

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I am not taking strong medication that affects liver enzymes.

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I haven't taken any cancer drugs within the last 21 days or 5 half-lives before starting the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline, at predefined intervals throughout the administration of azd0022; approximate duration of 2 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline, at predefined intervals throughout the administration of azd0022; approximate duration of 2 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline, at predefined intervals throughout the administration of azd0022; approximate duration of 2 years. for reporting.