A Study of AZD4635 With Durvalumab and With Cabazitaxel and Durvalumab in Patients With mCRPC.

Completed · Phase 2

Conditions studied: Progressive Metastatic Castrate-Resistant Prostate Cancer

In brief

This is a Phase II, international, open-label, two-arm, non-randomised study of AZD4635 in participants with metastatic castration-resistant prostate cancer (mCRPC).

Key facts

Study ID

NCT04495179

Run by

AstraZeneca

People needed

30

Starts

2020-08-04

Expected to finish

2022-08-08

Last updated by the study team

2023-08-09

Who can join

Age: 18 and older, up to 150. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed adenocarcinoma of the prostate.
• Known castrate-resistant disease.
• Evidence of disease progression ≤6 months.
• Body weight >30 kg at screening.
• Willingness to adhere to the study treatment-specific contraception requirements.
• Adequate bone marrow reserve and organ function.
• Adequate organ function for Arm A as demonstrated by all of the following laboratory values:
• Alanine aminotransferase (ALT) ≤2.5 × upper limit of normal (ULN) if no demonstrable liver metastases or ≤5 × ULN in the presence of liver metastases.
• Aspartate aminotransferase (AST) ≤2.5 × ULN if no demonstrable liver metastases or ≤5 × ULN in the presence of liver metastases
• Total bilirubin (TBL) ≤1.5 × ULN
• TBL ≤2.0 × ULN in the case of known Gilbert syndrome with normal direct bilirubin
• Participants in Arm A must have received the following prior therapy:
• Maximum of 3 lines of therapy in the mCRPC setting
• Prior therapy with one or more NHAs (eg, abiraterone acetate, enzalutamide, apalutamide, darolutamide) in either hormone-sensitive or hormone-refractory settings
• Prior therapy with one or more lines of taxanes (eg, docetaxel and/or cabazitaxel)
• Alternatively, must be taxane-ineligible
• Prior therapy can be in either the hormone-sensitive or the hormone-refractory setting
• Adequate organ function for Arm B as demonstrated by all of the following laboratory values:
• AST and/or ALT ≤1.5 × ULN
• TBL ≤ ULN
• TBL ≤2.0 × ULN in the case of known Gilbert syndrome with normal direct bilirubin
• Participants in Arm B must have received the following prior therapy:
• Prior docetaxel (taxane) in either hormone-sensitive or hormone-refractory settings
• Received no prior cytotoxic chemotherapy other than docetaxel for prostate cancer except for estramustine and except adjuvant/neo-adjuvant treatment completed >3 years ago.
• Prior therapy with only one NHAs (eg, abiraterone acetate or enzalutamide; prior apalutamide is not permitted) for treatment of mCRPC in either hormone-sensitive or hormone-refractory settings.

You may not qualify if…

• Active brain metastases or leptomeningeal metastases.
• There must be no requirement for immunosuppressive doses of systemic corticosteroids for at least 2 weeks prior to study enrollment.
• History of pneumonitis requiring corticosteroids, second malignancy that is progressing and/or received active treatment ≤3 years before the first dose of study intervention, and hypersensitivity to polysorbate-80 if allocated to cabazitaxel.
• As judged by the Investigator, any evidence of severe or uncontrolled systemic diseases.
• Creatinine clearance <40 mL/min (calculated by Cockcroft-Gault equation).
• Prior exposure to immune-mediated therapy including.
• Ongoing treatment with warfarin (Coumadin).
• Major surgery (excluding placement of vascular access) within 4 weeks of the first dose of study intervention.

Where it is running

• Research Site — Tampa, Florida, United States
• Research Site — Sacramento, California, United States
• Research Site — Atlanta, Georgia, United States
• Research Site — St Louis, Missouri, United States
• Research Site — Winston-Salem, North Carolina, United States
• Research Site — Brasschaat, Belgium
• Research Site — Ghent, Belgium
• Research Site — Bordeaux, France
• Research Site — Villejuif, France
• Research Site — Goyang-si, South Korea
• Research Site — Seoul, South Korea
• Research Site — Seoul, South Korea
• Research Site — Barcelona, Spain
• Research Site — Barcelona, Spain
• Research Site — Hospitalet deLlobregat, Spain
• Research Site — Madrid, Spain

Full record on ClinicalTrials.gov

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