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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

NCT06188520 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 564

Last updated 2026-05-11

No results posted yet for this 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.

Conditions

  • ER+ HER2- Advanced Breast Cancer
  • High-grade Serous Ovarian Cancer (HGSOC)

Interventions

DRUG

AZD8421

CDK2 inhibitor

DRUG

Camizestrant

SERD

DRUG

Ribociclib

CDK4/6 inhibitor

DRUG

Palbociclib

CDK4/6 inhibitor

DRUG

Abemaciclib

CDK4/6 inhibitor

Sponsors & Collaborators

Principal Investigators

  • Richard Baird, MD, PhD · Cambridge University Hospitals

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-05
Primary Completion
2027-08-04
Completion
2027-08-04
FDA Drug
Yes

Countries

  • United States
  • Australia
  • South Korea
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06188520 on ClinicalTrials.gov