Study identifier:D7080C00001
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
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)
Advanced Solid Tumours
Phase 1/2
No
AZD0022, Cetuximab
All
430
Interventional
18 Years - n/a
Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Sept 2024 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Module 1 Part A. Dose Escalation AZD0022 monotherapy | Drug: AZD0022 AZD0022 is an oral KRASG12D inhibitor that blocks KRASG12D function in patients with this type of mutation. |
Experimental: Module 1 Part B. Dose Optimisation AZD0022 monotherapy | Drug: AZD0022 AZD0022 is an oral KRASG12D inhibitor that blocks KRASG12D function in patients with this type of mutation. |
Experimental: Module 1 Part C. Potential Efficacy Expansion AZD0022 monotherapy | Drug: AZD0022 AZD0022 is an oral KRASG12D inhibitor that blocks KRASG12D function in patients with this type of mutation. |
Experimental: Module 1 Part B. Food Effect Cohort AZD0022 monotherapy | Drug: AZD0022 AZD0022 is an oral KRASG12D inhibitor that blocks KRASG12D function in patients with this type of mutation. |
Experimental: Module 2 Part A. Dose Escalation AZD0022 in combination with Cetuximab | Drug: AZD0022 AZD0022 is an oral KRASG12D inhibitor that blocks KRASG12D function in patients with this type of mutation. Drug: Cetuximab Cetuximab (Erbitux®) is a recombinant chimeric human/mouse Immunoglobulin G monoclonal antibody which binds to EGFR and competitively inhibits the binding of EGFR and other ligands |
Experimental: Module 2 Part B. Dose Optimisation AZD0022 in combination with Cetuximab | Drug: AZD0022 AZD0022 is an oral KRASG12D inhibitor that blocks KRASG12D function in patients with this type of mutation. Drug: Cetuximab Cetuximab (Erbitux®) is a recombinant chimeric human/mouse Immunoglobulin G monoclonal antibody which binds to EGFR and competitively inhibits the binding of EGFR and other ligands |
Experimental: Module 2 Part C. Potential Efficacy Expansion AZD0022 in combination with Cetuximab | Drug: AZD0022 AZD0022 is an oral KRASG12D inhibitor that blocks KRASG12D function in patients with this type of mutation. Drug: Cetuximab Cetuximab (Erbitux®) is a recombinant chimeric human/mouse Immunoglobulin G monoclonal antibody which binds to EGFR and competitively inhibits the binding of EGFR and other ligands |