A Phase I/II, Modular, Open-Label, Multi-Centre Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of AZD9750 as Monotherapy and in Combination With Other Anticancer Agents in Participants With Metastatic Prostate Cancer (ANDROMEDA)
AstraZeneca
Summary
ANDROMEDA is a first-in-human, Phase I/II, open-label, multicenter study of AZD9750 in participants with metastatic prostate cancer. The trial evaluates safety, tolerability, pharmacokinetics/pharmacodynamics, and preliminary efficacy of AZD9750 as monotherapy and in combination with saruparib.
Description
This first-in-human (FiH), Phase I/II, open-label, multicenter study will evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of AZD9750 as monotherapy and in combination with saruparib in participants with metastatic prostate cancer. Additional combinations with other anticancer agents may be added via protocol amendment as separate modules. The study follows a modular design, allowing initial assessment of safety, tolerability, and preliminary efficacy across multiple treatment arms. Each Module has 2 parts: Part A (monotherapy dose escalation or combi…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
* Inclusion Criteria: * Participant must be ≥18 years or the legal age at the time of signing the informed consent form. * Histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate. * Documented metastatic disease. * Serum testosterone levels ≤ 50 ng/dL. * Evidence of disease progression with one of the following: 1. PSA progression defined by a minimum of 3 rising PSA levels with an interval of ≥ 1 week between each determination. 2. Radiographic progression of soft tissue disease by RECIST v1.1 with or without PSA progression. 3. Radiograph…
Interventions
- DrugAZD9750
AR-PROTAC
- DrugAZD5305
PARP1-selective inhibitor
Locations (18)
- Research SiteDuarte, California
- Research SiteSan Francisco, California
- Research SiteTampa, Florida
- Research SiteBoston, Massachusetts
- Research SiteSt Louis, Missouri
- Research SiteMyrtle Beach, South Carolina