TerminatedPhase 1

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

Stopped: The decision to cease enrolment and proceed with the early termination of the ALAFOSS 01 (D7080C00001) study was based on strategic company portfolio prioritization.

United States, Australia, Japan17 participantsStarted 2024-10-18

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Participant must be ≥ 18 years or the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the ICF.
✓. Participants must have a histologically or cytologically confirmed metastatic or locally advanced tumour. Further details on tumour types are specified in Module-specific inclusion criteria.
✓. Participants must have received and progressed on, are refractory or are intolerant to standard therapy for the specific tumour type, or as per Module-specific criteria. Participants with contraindications to, or who refuse SoC therapy may be considered, provided that it is documented and the participant has been informed about all available therapeutic options.
✓. Documented KRASG12D mutation in tissue or liquid biopsy.
✓. Provision of a FFPE tumour sample.
✓. Participants must have at least one measurable target lesion per RECIST v1.1.
✓. Adequate organ and marrow function as defined in study protocol.
✓. Type of tumours with a KRASG12D mutation:

Exclusion criteria

What they're measuring

Incidence of participants with Dose-Limiting Toxicity (DLT), Adverse events (AEs) and Serious Adverse Events (SAEs).

Timeframe: 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

Timeframe: From time of informed consent to 30 days post last dose

ORR (Objective Response Rate)

Timeframe: Time from first dose of AZD002 through study completion; approximate duration of 2 years

Trial details

NCT IDNCT06599502

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-10-20

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