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NCT06188520 · ClinicalTrials.gov registry record · Phase 1

A First-in-human Dose Escalation and Expansion Study to Evaluate the Safety, and Tolerability of AZD8421 Alone or in Combination in Participants With Selected Advanced or Metastatic Solid Tumors

A Phase 1 study of ER+ HER2- Advanced Breast Cancer and High-grade Serous Ovarian Cancer (HGSOC), sponsored by AstraZeneca.

Recruiting
Registry status
Phase 1
Development phase
564
Enrollment target
14
Study locations

NCT06188520: Recruiting Phase 1 study of ER+ HER2- Advanced Breast Cancer and High-grade Serous Ovarian Cancer (HGSOC), sponsored by AstraZeneca.

NCT06188520 is a Phase 1 study of ER+ HER2- Advanced Breast Cancer and High-grade Serous Ovarian Cancer (HGSOC) that is actively recruiting participants, run by AstraZeneca. The registered enrollment target is 564 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (840% higher). The trial reports 14 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06188520, a Phase 1 study of ER+ HER2- Advanced Breast Cancer and High-grade Serous Ovarian Cancer (HGSOC), is actively recruiting participants, sponsored by AstraZeneca.

RECRUITING
Registry status
Phase 1
Development phase
564 participants
Enrollment target
14
Study locations

Study Summary

This study is designed to evaluate AZD8421 alone and in combination with selected targeted anti-cancer drugs in patients with ER+HER2- advanced breast cancer, and patients with metastatic high-grade serious ovarian cancer.

Primary Outcome

Percentage of participants with incidence of DLTs.

Interventions

  • DRUG Camizestrant
  • DRUG Palbociclib
  • DRUG Abemaciclib
  • DRUG Ribociclib
  • DRUG AZD8421

Study Locations (14)

Other

  • Research Site - East Melbourne
  • Research Site - Seoul
  • Research Site - Seoul
  • Research Site - Barcelona
  • Research Site - Pamplona
  • Research Site - Valencia
  • Research Site - Cambridge
  • Research Site - Leeds
  • Research Site - London
  • Research Site - Manchester

Missouri

  • Research Site - St Louis

Rhode Island

  • Research Site - Providence

Tennessee

  • Research Site - Nashville

Texas

  • Research Site - Houston

Trial Details

FieldValue
Enrollment Target 564 participants
Start Date 2023-12-05
Est. Completion 2027-08-04
Phase Phase 1
AstraZeneca

1,285 total trials

What NCT06188520 shows while recruiting

NCT06188520 is an interventional study that assigns participants to a tested intervention. The registered 564 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (840% higher).

The record links to 2 conditions, with ER+ HER2- Advanced Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Camizestrant is the first listed.

NCT06188520 lists 14 locations in 5 states (Other, Missouri, Rhode Island).

Frequently Asked Questions

What is clinical trial NCT06188520 about?

NCT06188520 is a clinical study titled "A First-in-human Dose Escalation and Expansion Study to Evaluate the Safety, and Tolerability of AZD8421 Alone or in Combination in Participants With Selected Advanced or Metastatic Solid Tumors". This study is designed to evaluate AZD8421 alone and in combination with selected targeted anti-cancer drugs in patients with ER+HER2- advanced breast cancer, and patients with metastatic high-grade serious ovarian cancer.

What is the current status of trial NCT06188520?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 564 participants. The study started on 2023-12-05. Estimated completion is 2027-08-04.

What conditions does trial NCT06188520 study?

This clinical trial studies the following conditions: ER+ HER2- Advanced Breast Cancer, High-grade Serous Ovarian Cancer (HGSOC).

What interventions are being tested in trial NCT06188520?

The interventions under investigation include: Camizestrant (DRUG), Palbociclib (DRUG), Abemaciclib (DRUG), Ribociclib (DRUG), AZD8421 (DRUG).

Who is sponsoring clinical trial NCT06188520?

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

Where is trial NCT06188520 being conducted?

This trial has 14 study locations across Missouri, Rhode Island, Tennessee, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for ER+ HER2- Advanced Breast Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06188520's enrollment target sits among peer trials

564 35th of 2000 higher than 1,966 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 NCT06188520, the US trial registry maintained by the National Library of Medicine. NCT06188520 (mid enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.