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

Part of paid clinical trials in Duarte, California.

Sponsor
AstraZeneca
Study ID
NCT07336446
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AZD9750 — DRUG
    AR-PROTAC
  • AZD5305 — DRUG
    PARP1-selective inhibitor

Study Details

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.

Key Dates

Start date
Jan 27, 2026
Status verified
Apr 2026
Primary completion
Jan 26, 2029
Completion
Jan 26, 2029

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

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

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 ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Research SiteDuarteCalifornia91010-
Research SiteSan FranciscoCalifornia94143-
Research SiteTampaFlorida33612-
Research SiteBostonMassachusetts02114-
Research SiteSt LouisMissouri63108-
Research SiteMyrtle BeachSouth Carolina29572-
Research SiteNashvilleTennessee37203-
Research SiteSalt Lake CityUtah84112-

Find similar trials in Duarte, CA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Research Site· Duarte, CAResearch Site· San Francisco, CAResearch Site· Tampa, FLResearch Site· Boston, MAResearch Site· St Louis, MOResearch Site· Myrtle Beach, SC

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