Recruiting
Phase 1
Phase 2

AZD9750 & Saruparib

Sponsor:

AstraZeneca

Code:

NCT07336446

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

AZD9750

AZD5305

Study Details

Brief 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.

Conditions

Prostate Cancer

Study ID

NCT07336446

Start date

Jan 27, 2026

Status verified date

Aug, 2026

Completion date

Jan 26, 2029

Anticipated

Primary completion date

Jan 26, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

  • 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

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Module 1 / Part A1

AZD9750 Monotherapy (Dose Escalation) - No randomization

experimental: Module 1 / Part A2

AZD9750 Monotherapy (Backfills) - No randomization

experimental: Module 1 / Part B1

AZD9750 Monotherapy (Dose Optimization) - Randomization

experimental: Module 1 Part B2

AZD9750 Monotherapy (Dose Expansion) - No randomization

experimental: Module 1 / Part B3

AZD9750 Monotherapy (Dose Expansion) - No randomization

experimental: Module 2 / Part A

AZD9750 + Saruparib (Combination Dose Finding) - No Randomization

experimental: Module 2/ Part B

AZD9750 + Saruparib (Combination Dose Expansion) - No Randomization

Interventions

AZD9750

AR-PROTAC

AZD5305

PARP1-selective inhibitor

Primary outcome measure

  • Number of participants with dose-limiting toxicity (DLT), as defined in the protocol (Part A only) [ Time Frame: From first dose of study intervention to 28 days post first dose ]
  • Number of participants with Adverse Events and Serious Adverse Events [ Time Frame: From first dose of study intervention up to 37 days after the last dose of study treatment ]
  • Number of participants with Adverse Events leading to discontinuation of study intervention [ Time Frame: From first dose of study intervention up to 37 days after the last dose of study treatment ]
  • Clinically significant changes from baseline in vital signs. [ Time Frame: From first study dose up to 37 days after the last dose of study treatment ]
  • Clinically significant changes from baseline in physical examination. [ Time Frame: From first dose of study intervention up to 37 days after the last dose of study treatment ]
  • Clinically significant changes from baseline in ECOG PS. [ Time Frame: From first dose of study intervention up to 37 days after the last dose of study treatment ]
  • Clinically significant changes from baseline in ECGs. [ Time Frame: From first dose of study intervention up to 37 days after the last dose of study treatment ]
  • Clinically significant changes from baseline in laboratory parameters. [ Time Frame: From first dose of study intervention up to 37 days after the last dose of study treatment ]
  • Proportion of participants achieving a ≥50% decrease in PSA from baseline (PSA50) (Part B only) [ Time Frame: From first dose of study intervention up to 14 days after the last dose of study treatment ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479information.center@astrazeneca.com

Locations

Research Site

Recruiting

Duarte, California, United States, 91010

Research Site

Recruiting

Boston, Massachusetts, United States, 02114

Research Site

Recruiting

St Louis, Missouri, United States, 63108

Research Site

Recruiting

Myrtle Beach, South Carolina, United States, 29572

Research Site

Recruiting

Nashville, Tennessee, United States, 37203

Research Site

Recruiting

Salt Lake City, Utah, United States, 84112

Research Site

Recruiting

Calgary, Alberta, Canada, T2N 5G2

More Information

Sponsor

AstraZeneca

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Keywords

  • Metastasic Prostate Cancer
  • Prostate Cancer
  • Androgen Receptor
  • Proteolysis-targeting chimeras (PROTACs)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-08-10.