Viewing Study NCT06599502



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

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