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 - ALAFOSS-01

Study identifier:D7080C00001

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Will Be Recruiting

Official 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)

Medical condition

Advanced Solid Tumours

Phase

Phase 1/2

Healthy volunteers

No

Study drug

AZD0022, Cetuximab

Sex

All

Estimated Enrollment

430

Study type

Interventional

Age

18 Years - n/a

Date

Study Start Date: 04 Oct 2024
Estimated Primary Completion Date: 20 Jan 2028
Estimated Study Completion Date: 20 Jan 2028

Study design

Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Sept 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria