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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)

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-516699-14-00
Acronym
D7080C00001
Enrollment
126
Registered
2025-03-13
Start date
2025-04-23
Completion date
2025-10-09
Last updated
2025-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Small Cell Lung Cancer Colorectal Cancer Pancreatic Ductal Adenocarcinoma

Brief summary

For Parts A & B: • Incidence and severity of AEs/SAEs • Incidence of DLTs (Dose Escalation) • Clinically significant changes in vital signs, laboratory parameters, and ECG results • Discontinuation of AZD0022 due to toxicity For Part C: • ORR evaluated according to RECIST v1.1

Detailed description

For Parts A&B: • Radiological response evaluated according to RECIST v1.1 (ORR, CR rate, DoR, DCR, DRR, TTR, PFS, and change in tumour size). • OS, Continuation of Parts A&B as some translations total more than 500 characters. The proportion of participants demonstrating a complete molecular response upon treatment • Determine plasma, urine, and whole blood concentrations and where appropriate determine PK parameters including, but not limited to Cmax, tmax, AUClast, and t1/2λz after oral administration of AZD0022 and amount excreted in urine., For Part C: • Incidence of AEs/SAEs • Clinically significant changes in vital signs, laboratory parameters, and ECG results • AZD0022 discontinuation due to toxicity • Radiological response evaluated according to RECIST v1.1 (CR rate, DoR, DCR, DRR, TTR, PFS, and change in tumour size), Continuation of Part C as some translation total more than 500 characters • OS • The proportion of participants demonstrating a complete molecular response upon treatment • TDT • TFST

Interventions

DRUGErbitux 5 mg/mL solution for infusion

Sponsors

AstraZeneca AB
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
For Parts A & B: • Incidence and severity of AEs/SAEs • Incidence of DLTs (Dose Escalation) • Clinically significant changes in vital signs, laboratory parameters, and ECG results • Discontinuation of AZD0022 due to toxicity For Part C: • ORR evaluated according to RECIST v1.1

Secondary

MeasureTime frame
For Parts A&B: • Radiological response evaluated according to RECIST v1.1 (ORR, CR rate, DoR, DCR, DRR, TTR, PFS, and change in tumour size). • OS, Continuation of Parts A&B as some translations total more than 500 characters. The proportion of participants demonstrating a complete molecular response upon treatment • Determine plasma, urine, and whole blood concentrations and where appropriate determine PK parameters including, but not limited to Cmax, tmax, AUClast, and t1/2λz after oral administration of AZD0022 and amount excreted in urine., For Part C: • Incidence of AEs/SAEs • Clinically significant changes in vital signs, laboratory parameters, and ECG results • AZD0022 discontinuation due to toxicity • Radiological response evaluated according to RECIST v1.1 (CR rate, DoR, DCR, DRR, TTR, PFS, and change in tumour size), Continuation of Part C as some translation total more than 500 characters • OS • The proportion of participants demonstrating a complete molecular response

Countries

Belgium, Italy, Netherlands, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026