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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Male
Accepts 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. 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). - Any clinically significant cardiovascular diseases including symptomatic heart failure, uncontrolled hypertension, acute coronary syndrome, cardiomyopathy, valvular heart disease, atrial fibrillation, stroke. - 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 Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
First-in-human, modular, open-label, Phase I/II study with sequential assignment across modules and parts: Part A (monotherapy dose escalation or combination dose finding) and Part B (dose optimization and expansion), evaluating AZD9750 as monotherapy and in combination with saruparib in participants with metastatic prostate cancer.
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Module 1 / Part A1 		AZD9750 Monotherapy (Dose Escalation) - No randomization
  • Drug: AZD9750
    AR-PROTAC
Experimental
Module 1 / Part A2 		AZD9750 Monotherapy (Backfills) - No randomization
  • Drug: AZD9750
    AR-PROTAC
Experimental
Module 1 / Part B1 		AZD9750 Monotherapy (Dose Optimization) - Randomization
  • Drug: AZD9750
    AR-PROTAC
Experimental
Module 1 Part B2 		AZD9750 Monotherapy (Dose Expansion) - No randomization
  • Drug: AZD9750
    AR-PROTAC
Experimental
Module 1 / Part B3 		AZD9750 Monotherapy (Dose Expansion) - No randomization
  • Drug: AZD9750
    AR-PROTAC
Experimental
Module 2 / Part A 		AZD9750 + Saruparib (Combination Dose Finding) - No Randomization
  • Drug: AZD9750
    AR-PROTAC
  • Drug: AZD5305
    PARP1-selective inhibitor
    Other names:
    • Saruparib
Experimental
Module 2/ Part B 		AZD9750 + Saruparib (Combination Dose Expansion) - No Randomization
  • Drug: AZD9750
    AR-PROTAC
  • Drug: AZD5305
    PARP1-selective inhibitor
    Other names:
    • Saruparib

Recruiting Locations

Research Site
Duarte, California 91010

Research Site
St Louis, Missouri 63108

Research Site
Myrtle Beach, South Carolina 29572

Research Site
Nashville, Tennessee 37203

More Details

Status
Recruiting
Sponsor
AstraZeneca

Study Contact

AstraZeneca Clinical Study Information Center
1-877-240-9479
information.center@astrazeneca.com

Detailed 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 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.