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NCT06599502 · ClinicalTrials.gov registry record · Phase 1
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 1 study, sponsored by AstraZeneca.
- Terminated
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
NCT06599502: Clinical Trial Phase 1 study, sponsored by AstraZeneca.
NCT06599502 is a Phase 1 study that was terminated before completion, run by AstraZeneca. The registered enrollment target is 17 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06599502, a Phase 1 study, was terminated before completion, sponsored by AstraZeneca.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
Study 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.
Primary Outcome
Determine if treatment with AZD0022 as a monotherapy and in combination with other anti-cancer agents is safe and tolerable through the assessment of DLTs, AEs, SAEs, and change from baseline in laboratory parameters, vital signs, and ECGs. Part A (Dose Escalation) and Part B (Dose Optimisation). DLTs only applicable for Part A.
Interventions
- DRUG Cetuximab
- DRUG AZD0022
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2024-10-18 |
| Est. Completion | 2026-01-29 |
| Phase | Phase 1 |
Why NCT06599502 stopped before completion
NCT06599502 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 2 interventions - of which Cetuximab is the first listed.
NCT06599502 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06599502 about?
NCT06599502 is a clinical study titled "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". 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.
What is the current status of trial NCT06599502?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2024-10-18. Estimated completion is 2026-01-29.
What interventions are being tested in trial NCT06599502?
The interventions under investigation include: Cetuximab (DRUG), AZD0022 (DRUG).
Who is sponsoring clinical trial NCT06599502?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06599502's enrollment target sits among peer trials
17 1785th of 2000 higher than 215 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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