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NCT05397171 · ClinicalTrials.gov registry record · Phase 1

A First-in-human Study to Evaluate the Safety and Tolerability of AZD8853 in Participants With Selected Advanced/Metastatic Solid Tumours

A Phase 1 study, sponsored by AstraZeneca.

Terminated
Registry status
Phase 1
Development phase
17
Enrollment target

NCT05397171: Clinical Trial Phase 1 study, sponsored by AstraZeneca.

NCT05397171 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.

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The verdict

NCT05397171, a Phase 1 study, was terminated before completion, sponsored by AstraZeneca.

TERMINATED
Registry status
Phase 1
Development phase
17 participants
Enrollment target

Study Summary

A Phase I/IIa First-in-human, Open-label Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of AZD8853 in Participants with Selected Advanced/Metastatic Solid Tumours.

Primary Outcome

The safety and tolerability of AZD8853 in participants with selected advanced/metastatic solid tumors was assessed. As per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0, severity scale ranged from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event. This outcome measure was assessed only for substudy 1 Part A.

Interventions

  • DRUG AZD8853
  • DRUG Zirconium-89 crefmirlimab berdoxam

Trial Details

FieldValue
Enrollment Target 17 participants
Start Date 2022-06-07
Est. Completion 2023-06-06
Phase Phase 1
AstraZeneca

1,285 total trials

Why NCT05397171 stopped before completion

NCT05397171 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 AZD8853 is the first listed.

NCT05397171 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05397171 about?

NCT05397171 is a clinical study titled "A First-in-human Study to Evaluate the Safety and Tolerability of AZD8853 in Participants With Selected Advanced/Metastatic Solid Tumours". A Phase I/IIa First-in-human, Open-label Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of AZD8853 in Participants with Selected Advanced/Metastatic Solid Tumours.

What is the current status of trial NCT05397171?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2022-06-07. Estimated completion is 2023-06-06.

What interventions are being tested in trial NCT05397171?

The interventions under investigation include: AZD8853 (DRUG), Zirconium-89 crefmirlimab berdoxam (DRUG).

Who is sponsoring clinical trial NCT05397171?

This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05397171'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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Source: ClinicalTrials.gov NCT05397171, the US trial registry maintained by the National Library of Medicine. NCT05397171 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.