Study identifier:D8470C00001
ClinicalTrials.gov identifier:NCT06188520
EudraCT identifier:N/A
CTIS identifier:2023-507305-33-00
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
ER+ HER2- Advanced Breast Cancer
Phase 1/2
No
AZD8421, Camizestrant, Ribociclib, Palbociclib, Abemaciclib
Female
348
Interventional
18 Years - n/a
Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Apr 2025 by AstraZeneca
AstraZeneca
-
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.
This is a first in-human study of AZD8421 administered to participants with advanced or metastatic solid tumors. The study will evaluate the safety, tolerability, preliminary efficacy, pharmacokinetics, and pharmacodynamics of AZD8421 alone and in combination with selected targeted anti-cancer drugs. AZD8421 monotherapy (M1) will evaluate the safety, tolerability and pharmacokinetics of AZD8421 as monotherapy to identify a recommended Phase II dose (RP2D) in participants with ER+ HER2- advanced breast cancer previously treated with a CDK4/6i (Parts A and B) and participants with metastatic high-grade serous ovarian cancer previously treated with a platinum-based chemotherapy in the metastatic setting (Part B). AZD8421 combination therapy (M2) will evaluate the safety, tolerability, and pharmacokinetics of AZD8421 in combination with a CDK4/6 inhibitor (one or more of abemaciclib, ribociclib and palbociclib) and camizestrant (next generation oral SERD; referred to throughout as ‘camizestrant’) in participants with ER+ HER2- advanced breast cancer previously treated with a CDK4/6 inhibitor.
Location
Status
Location
East Melbourne, Australia, 3002
Status
Recruiting
Location
Seoul, Republic of Korea, 03722
Status
Recruiting
Location
Seoul, Republic of Korea, 06351
Status
Recruiting
Location
Houston, TX, United States, 77030
Status
Recruiting
Location
Cambridge, United Kingdom, CB2 0XY
Status
Recruiting
Location
Leeds, United Kingdom, LS9 7TF
Status
Recruiting
Location
Nashville, TN, United States, 37201
Status
Recruiting
Location
Saint Louis, MO, United States, 63141
Status
Recruiting
Arms | Assigned Interventions |
---|---|
Experimental: Module 1 AZD8421 monotherapy | Drug: AZD8421 CDK2 inhibitor Other Name: N/A |
Experimental: Module 2A_abema AZD8421 with camizestrant and abemaciclib | Drug: AZD8421 CDK2 inhibitor Other Name: N/A Drug: Camizestrant SERD Other Name: AZD9833 Drug: Abemaciclib CDK4/6 inhibitor Other Name: Verzenios |
Experimental: Module 2A_ribo AZD8421 with camizestrant and ribociclib | Drug: AZD8421 CDK2 inhibitor Other Name: N/A Drug: Camizestrant SERD Other Name: AZD9833 Drug: Ribociclib CDK4/6 inhibitor Other Name: Kisqali |
Experimental: Module 2A_palbo AZD8421 with camizestrant and palbociclib | Drug: AZD8421 CDK2 inhibitor Other Name: N/A Drug: Camizestrant SERD Other Name: AZD9833 Drug: Palbociclib CDK4/6 inhibitor Other Name: Ibrance |
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