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 - CYCAD-1

Study identifier:D8470C00001

ClinicalTrials.gov identifier:NCT06188520

EudraCT identifier:N/A

CTIS identifier:N/A

Recruiting

Official Title

A Phase I/IIa, First-in-human, Open-label, Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of AZD8421 Alone or in Combination in Participants with Selected Advanced or Metastatic Solid Tumors

Medical condition

ER+ HER2- Advanced Breast Cancer, High-grade serous ovarian cancer (HGSOC)

Phase

Phase 1/2

Healthy volunteers

No

Study drug

AZD8421, Camizestrant, Ribociclib, Palbociclib, Abemaciclib

Sex

Female

Estimated Enrollment

204

Study type

Interventional

Age

18 Years - n/a

Date

Study Start Date: 05 Dec 2023
Estimated Primary Completion Date: 18 Jun 2025
Estimated Study Completion Date: 18 Jun 2025

Study design

Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Feb 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria