ALAFOSS-01
Research type
Research Study
Full title
A Phase I/IIa, Open-label, Multi-centre Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of AZD0022 Monotherapy and in Combination with Anti-cancer Agents in Participants with Tumours Harbouring a KRASG12D Mutation (ALAFOSS-01)
IRAS ID
1010984
Contact name
Niloufar Davoudi
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2024-516699-14
Clinicaltrials.gov Identifier
Research summary
Research Summary: This trial aims to explore a new treatment for patients with lung, colon, and pancreatic cancers with a genetic mutation called KRAS-G12D. These mutations often make tumors grow faster and harder to treat. The new drug, AZD0022, is being tested alone and in combination with another drug called cetuximab, which blocks a protein that helps cancer cells grow.
Purpose and Importance: The study seeks to assess the safety and effectiveness of AZD0022, and how AZD0022 moves throughout the body in people with KRAS-G12D mutated tumours. This is essential for developing better treatments for these challenging tumors.
Study Design: The research is a Phase 1/2a, open-label, first-in-human trial, meaning it’s the first time the drug is tested in people. Participants and doctors know what treatments are given. The trial includes two stages: one with AZD0022 alone and another with AZD0022 in combination with cetuximab. Each stage involves multiple dose trials to find the safest and most effective treatment.
Participant Involvement:
•Eligibility: Adults 18+ with KRAS-G12D mutation in lung, colon, or pancreatic cancer, without other serious health conditions.
•Procedures: Participants take AZD0022 orally, while cetuximab is given through a needle directly into a vein (IV infusion). Health monitoring involves regular blood and urine tests, scans (like CT and MRI), biopsies, and ECGs for heart health.
Potential Benefits and Risks: Participants might not benefit directly, but the trial may help future patients by improving medical care and disease understanding. Risks include heart and blood vessel issues, digestive problems, and changes in blood cell counts or liver enzyme levels.
Recruitment and Duration: Up to 430 participants will be recruited from hospitals and research centers worldwide. The trial lasts until the cancer progresses, side effects become severe, or participants opt out.
For more information, contact the participating research centres.REC name
North East - York Research Ethics Committee
REC reference
25/NE/0086
Date of REC Opinion
30 Jun 2025
REC opinion
Further Information Unfavourable Opinion