Trials / Terminated
TerminatedNCT06599502
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
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)
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 17 (actual)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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).
Conditions
- Advanced Solid Tumours
- Non-Small Cell Lung Cancer (NSCLC)
- Pancreatic Ductal Adenocarcinoma (PDAC)
- Colorectal Cancer (CRC)
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2024-10-18
- Primary completion
- 2025-10-20
- Completion
- 2026-01-29
- First posted
- 2024-09-19
- Last updated
- 2026-03-18
Locations
6 sites across 4 countries: United States, Australia, Japan, South Korea
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06599502. Inclusion in this directory is not an endorsement.