Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06599502
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-19
Brief Title:
A Phase IIIa 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
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase IIIa 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:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ALAFOSS-01
Brief Summary:
This is a first-in-human modular Phase IIIa 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
Detailed Description:
This first time in human open-label multi-centre study will administer AZD0022 orally to participants with tumours harbouring a KRASG12D mutation
This study will have initially 2 modules
Module 1 AZD0022 monotherapy
Module 2 AZD0022 in combination with other anti-cancer agents Cetuximab
Each Module has 3 parts Dose Escalation Part A Dose Optimisation Part B and Potential Efficacy Expansion Part C
This study will have initially 2 modules
Module 1 AZD0022 monotherapy
Module 2 AZD0022 in combination with other anti-cancer agents Cetuximab
Each Module has 3 parts Dose Escalation Part A Dose Optimisation Part B and Potential Efficacy Expansion Part C
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None