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

A regiszterben nem jelölt feltételek

• 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).
  • 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.