drugset / Trial / NCT06599502

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

NCT06599502 ↗

Phase 1 Terminated 17 enrolled AstraZeneca
Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

Start
2024-10-18
Primary completion
2025-10-20
Completion
2026-01-29

Outcome

Outcome not reported

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

Drugs

EvaluationDrugModalityDoseRoute
Subject AZD0022 Unknown — Oral
Subject Cetuximab Monoclonal antibody — —