ClinicaliQ Trial Snapshot
- 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 — Recruiting • Phase I • Oncology • NCT07336446.
- What is being tested: AZD9750, a novel investigational agent, is being evaluated as monotherapy and in combination with saruparib (a PARP inhibitor) in metastatic prostate cancer patients, with assessment of safety, tolerability, and preliminary efficacy in this first-in-human Phase I/II trial.
- Patient eligibility overview: The trial recruits participants with confirmed metastatic prostate cancer; specific eligibility criteria regarding prior treatment history, performance status, and organ function would be detailed in the full protocol but represent a typical Phase I/II oncology population.
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- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
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What This Trial Is Studying
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.
Eligibility Snapshot
- : * 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). *…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.