Sanford Health | Clinical Research Department
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About
Evaluate the safety and tolerability of AMG 509 in adult participants and determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D).
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Inclusion criteria
Parts 1, 2, and 5: Participants with histologically or cytologically confirmed metastatic castration-resistant prostate cancer (mCRPC) who are refractory to a novel antiandrogen therapy (abiraterone acetate and/or enzalutamide, apalutamide, or darolutamide) and have failed at least 1 (but not more than 2) taxane regimens including for metastatic hormone-sensitive prostate cancer (mHSPC) (or who are deemed medically unsuitable to be treated with a taxane regimen or have actively refused treatment with a taxane regimen). Note: A taxane regimen is defined as a minimum exposure of 2 cycles of a taxane. Any NHT that has been administered and has been stopped for reasons other than progression will not be counted as an additional line of treatment.
Part 3: Participants with histologically or cytologically confirmed mCRPC who are refractory to a NHT (abiraterone acetate, enzalutamide, apalutamide, or darolutamide) given in any disease setting and who are deemed medically unsuitable to be treated with a taxane regimen or have actively refused treatment with a taxane regimen (no prior taxanes). 0-1 prior PARP inhibitors or sipuleucel-T treatments are acceptable. Participants who received prior investigational therapy for the treatment of metastatic disease are not eligible.
Parts 4A and 4B:
All parts:
Participants must have undergone bilateral orchiectomy or be on continuous androgen-deprivation therapy with a gonadotropin releasing hormone (GnRH) agonist or antagonist.
Total serum testosterone <= 50 ng/dL or 1.7 nmol/L.
Evidence of progressive disease, defined as 1 or more Prostate Cancer Working Group 3 (PCWG3) criteria:
Eastern Cooperative Oncology Group performance status of 0-1.
Adequate organ function, defined as follows:
Hematological function:
Renal function:
Hepatic function:
Cardiac function:
Part 3-Retreatment group:
Deriving benefit from initial treatment with AMG 509 as evidenced by one of the following:
No discontinuation for toxicity during the initial treatment with 6 cycles of AMG 509.
Progressive disease as defined in I106 within 12 months of final dose in their initial treatment with 6 cycles (EOT_1).
Willingness to have a fresh tumor biopsy prior to initiating the additional course of treatment, depending on safety and feasibility as assessed by investigator.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
461 participants in 5 patient groups
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Central trial contact
Amgen Call Center
Data sourced from clinicaltrials.gov
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