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A Trial to Learn How Safe AZD9750 is and How Well it Works in People With Metastatic Prostate Cancer When Given With or Without Other Anticancer Drugs
Trial Status: active
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.
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:
PSA progression defined by a minimum of 3 rising PSA levels with an interval of ≥ 1 week between each determination.
Radiographic progression of soft tissue disease by RECIST v1.1 with or without PSA progression.
Radiographic progression of bone metastasis with 2 or more documented new bone lesions on a bone scan with or without PSA progression.
ECOG performance status score of 0 or 1.
Adequate bone marrow and organ function.
Part A (Module 1)
(a) Part A1 dose escalation: at least 1 prior ARPI and, if applicable, at least 1 taxane-based chemotherapy (regardless of whether in HSPC or CRPC setting).
(b) Part A2 backfill: at least 1 but no more than 2 prior ARPIs and, if applicable, at least 1 but no more than 2 prior taxane-based chemotherapies (regardless of whether in HSPC or CRPC setting).
Part B (Module 1)
(a) B1/B2 dose optimization/expansion: at least 1 but no more than 2 prior ARPIs and, if applicable, at least 1 but no more than 2 prior taxane-based chemotherapies (regardless of whether in HSPC or CRPC setting).
(b) B3 dose expansion (no taxane cohort): at least 1 but no more than 2 prior ARPIs for metastatic prostate cancer (regardless of whether in HSPC or CRPC setting). No prior taxane is allowed for inclusion in this cohort. -
Exclusion Criteria
Participants with pathological finding consistent with any presence of small cell carcinoma, predominant neuroendocrine carcinoma, or any predominant histology other than prostate adenocarcinoma.
Brain metastases, or spinal cord compression.
Any clinically significant cardiac disorders including QT prolongation, abnormal electrocardiogram (ECG).
Active gastrointestinal disease or other condition that will interfere significantly with the absorption, distribution, metabolism of AZD9750 and relevant combination IMPs.
Participants with any known predisposition to bleeding (eg, active peptic ulceration, recent [within 6 months] hemorrhagic stroke, proliferative diabetic retinopathy).
Prior treatment with an AR-PROTAC. Other protocol-defined inclusion/exclusion criteria apply.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07336446.
Locations matching your search criteria
United States
California
Duarte
City of Hope Comprehensive Cancer Center
Status: Active
Name Not Available
Missouri
Saint Louis
Siteman Cancer Center at Washington University
Status: Active
Name Not Available
Utah
Salt Lake City
Huntsman Cancer Institute/University of Utah
Status: Active
Name Not Available
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 combination dose
finding) and Part B (monotherapy dose optimization and expansion or combination dose
expansion). Treatment continues until disease progression, unacceptable toxicity,
withdrawal of consent, or other reasons to discontinue study intervention occur.