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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Phase
Phase 1
Status
Terminated
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
17actual
Sites
6
Countries
Australia, Japan, South Korea +1
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Why the sponsor stopped it
The decision to cease enrolment and proceed with the early termination of the ALAFOSS 01 (D7080C00001) study was based on strategic company portfolio prioritization.
As filed on the registry record, in the sponsor's own words.
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-10-18 | actual | When the study began enrolling |
| Primary completion | 2025-10-20 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-01-29 | actual | The whole study's end, after follow-up |
| First posted | 2024-09-19 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-03-18 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Advanced Solid Tumours
- Non-Small Cell Lung Cancer (NSCLC)
- Pancreatic Ductal Adenocarcinoma (PDAC)
- Colorectal Cancer (CRC)
Interventions
- Drug: AZD0022
- Drug: Cetuximab
Primary outcomes
what the primary-completion date above is the date OFIncidence of participants with Dose-Limiting Toxicity (DLT), Adverse events (AEs) and Serious Adverse Events (SAEs).
measured From time of informed consent, through study completion to 30 days post last dose; an average of 2 years
Number of patients who discontinue AZD0022 due to toxicity
measured From time of informed consent to 30 days post last dose
ORR (Objective Response Rate)
measured Time from first dose of AZD002 through study completion; approximate duration of 2 years
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