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
AstraZeneca
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.
Description
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 hi…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Female participants only, aged 18 or above * Participants with advanced solid tumors must have received prior adequate therapy in accordance with local practice for their tumor type and stage of disease, or, in the opinion of the Investigator, a clinical study is the best option for their next treatment based on response to and/or tolerability of prior therapy. * Metastatic or locoregionally recurrent disease and radiological or objective evidence of progression on or after the last systemic therapy prior to starting IMP. * ECOG/WHO performance status 0 to 1, and a minim…
Interventions
- DrugAZD8421
CDK2 inhibitor
- DrugCamizestrant
SERD
- DrugRibociclib
CDK4/6 inhibitor
- DrugPalbociclib
CDK4/6 inhibitor
- DrugAbemaciclib
CDK4/6 inhibitor
Locations (14)
- Research SiteSt Louis, Missouri
- Research SiteProvidence, Rhode Island
- Research SiteNashville, Tennessee
- Research SiteHouston, Texas
- Research SiteEast Melbourne
- Research SiteSeoul