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New treatment option for Prostate Cancer
Official title Study of AMG 509 in Participants With Metastatic Castration-Resistant Prostate Cancer
ClinicalTrials.gov ID: NCT04221542
What this study is testing
What is AMG 509?
AMG 509 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for prostate cancer.
Also referred to as xaluritamig.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The overall aim of the trial is to evaluate the safety, tolerability, and pharmacokinetics (PK) of AMG 509 (monotherapy and in combination with abiraterone acetate and enzalutamide) and to evaluate preliminary efficacy. As of Protocol Amendment 10 (09 July 2025), only Parts 4A expansion, 6, and 7 are open to accrual.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Parts 1, 2, 5 and 7: Participants with histologically or cytologically confirmed metastatic castration-resistant prostate cancer (mCRPC) who are...
- Dose exploration phase: Novel antiandrogen therapy must have been given for treatment of metastatic disease.
- Dose-expansion phase: participants must not have had more than 2 NHTs and 2 taxane regimens in any setting, and an additional up to 2 other systemic...
- Part 3: Participants with histologically or cytologically confirmed mCRPC who have received no or 1-2 prior NHTs (abiraterone acetate, enzalutamide...
- Parts 4A, 4B and 7:
You likely can't join if
- Pathological finding consistent with pure small cell, neuroendocrine carcinoma of the prostate or any other histology different from adenocarcinoma.
- Radiation therapy within 4 weeks of first dose (or local or focal radiotherapy within 2 weeks of first dose).
- Untreated central nervous system (CNS) metastases or leptomeningeal disease. Participants with a history of treated CNS metastases are eligible if...
- Prior major surgery within 4 weeks of first dose.
- Participants with symptoms and/or clinical signs and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection...
- Confirmed history or current autoimmune disease or other diseases resulting in permanent immunosuppression or requiring permanent immunosuppressive...
See the full eligibility criteria
Who can join
- Parts 1, 2, 5 and 7: Participants with histologically or cytologically confirmed metastatic castration-resistant prostate cancer (mCRPC) who are refractory to a novel antiandrogen therapy (abiraterone acetate and/or...
- Dose exploration phase: Novel antiandrogen therapy must have been given for treatment of metastatic disease.
- Dose-expansion phase: participants must not have had more than 2 NHTs and 2 taxane regimens in any setting, and an additional up to 2 other systemic anti-cancer treatments are allowed (eg, anti-PD1, PARP inhibitors...
- Part 3: Participants with histologically or cytologically confirmed mCRPC who have received no or 1-2 prior NHTs (abiraterone acetate, enzalutamide, apalutamide, or darolutamide) given in any disease setting and who are...
- Parts 4A, 4B and 7:
- Participants with histologically or cytologically confirmed mCRPC who have received no or 1-2 prior NHTs (given in any disease setting depending on the part), and no or 1 taxane regimen (for HSPC).
- Dose-expansion phase: at least 1 prior NHT must have been given; 0-1 prior PARP inhibitors are acceptable.
- 4A: Participants planning to receive abiraterone acetate for the first time (participants who received prior abiraterone acetate are not eligible). Participants may have had exposure to up to 2 NHTs with a similar...
- Dose-expansion phase: up to approximately 10 participants with prior exposure to abiraterone acetate may be enrolled into Part 4A expansion cohort. d. 4B: Participants planning to receive enzalutamide for the first time...
- Part 6:
- Prior disease progression on 1, and only 1, NHT (either enzalutamide, apalutamide, or darolutamide) is required. NOTE: Prior progression on or intolerance to abiraterone is not allowed.
- No prior treatment with any chemotherapy regimen in the mCRPC setting; ≤ 6 cycles of docetaxel treatment in the mHSPC setting is allowed.
- mCRPC with ≥ 1 RECIST v1.1 measurable lesion that is present on baseline computed tomography (CT) or magnetic resonance imaging (MRI).
- 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:
- PSA level ≥ 1 ng/mL that has increased on at least 2 successive occasions at least 1 week apart.
- Nodal or visceral progression as defined by RECIST v1.1 with PCGW3 modifications.
- Appearance of 2 or more new lesions in bone scan.
- Eastern Cooperative Oncology Group performance status of 0-1.
- Life expectancy ≥ 3 months.
- Adequate organ function, defined as follows:
- Hematological function:
- absolute neutrophil count ≥ 1 x 10\^9/L (without growth factor support within 7 days from screening assessment).
- platelet count ≥ 75 x 10\^9/L (without platelet transfusion within 7 days from screening assessment).
- hemoglobin ≥ 9 g/dL (90 g/L) (without blood transfusion within 7 days from screening assessment).
- Renal function: 1\. estimated glomerular filtration rate based on Modification of Diet in Renal Disease calculation ≥ 30 ml/min/1.73 m\^2.
- Hepatic function:
- aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 3 x upper limit of normal (ULN) (or \< 5 x ULN for participants with liver involvement).
- total bilirubin (TBL) \< 1.5 x ULN (or \< 2 x ULN for participants with liver metastases).
- Cardiac function:
- left ventricular ejection fraction \> 50% (2-D transthoracic echocardiogram [ECHO] is the preferred method of evaluation; multi-gated acquisition scan is acceptable if ECHO is not available).
- Baseline electrocardiogram (ECG) QTcF ≤ 470 msec (average of triplicate values).
- Pulmonary function:
- baseline oxygen saturation \> 92% on room air at rest and no oxygen supplementation. Part 3-Retreatment group:
- Deriving benefit from initial treatment with AMG 509 as evidenced by one of the following:
- confirmed PSA50 response.
- radiographic stable disease/partial response/complete response during 6 cycles of initial treatment with AMG 509 and without progression during the first 6 cycles.
- 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. Key
What rules you out
- Pathological finding consistent with pure small cell, neuroendocrine carcinoma of the prostate or any other histology different from adenocarcinoma.
- Radiation therapy within 4 weeks of first dose (or local or focal radiotherapy within 2 weeks of first dose).
- Untreated central nervous system (CNS) metastases or leptomeningeal disease. Participants with a history of treated CNS metastases are eligible if there is radiographic evidence of improvement upon the completion of...
- Prior major surgery within 4 weeks of first dose.
- Participants with symptoms and/or clinical signs and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection within 7 days prior to the first dose of investigational product...
- Confirmed history or current autoimmune disease or other diseases resulting in permanent immunosuppression or requiring permanent immunosuppressive therapy.
- History of arterial or venous thrombosis (eg, stroke, transient ischemic attack, pulmonary embolism, or deep vein thrombosis); for arterial thrombosis within 12 months of AMG 509 initiation; for venous thrombosis, 6...
- Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association \> class II) within 12 months of first dose of AMG 509 with the exception of ischemia or non-ST segment elevation myocardial...
- Any anti-cancer therapy or immunotherapy within 4 weeks of start of first dose, not including luteinizing hormone-releasing hormone (LHRH)/GnRH analogue (agonist/antagonist).
- Prior prostate specific membrane antigen (PSMA) radionuclide therapy within 2 months prior to AMG 509 unless participant received \< 2 cycles (Note: a participant cannot have received PSMA radionuclide therapy \< 35...
- Part 3-Retreatment only: Any anti-cancer therapy or immunotherapy, not including luteinizing hormone-releasing hormone/gonadotropin releasing hormone (LHRH/GnRH) analogue (agonist/antagonist), and/or bisphosphonate or...
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Fullerton, California, United States
- San Francisco, California, United States
- Aurora, Colorado, United States
- New Haven, Connecticut, United States
- Atlanta, Georgia, United States
- Indianapolis, Indiana, United States
- Merriam, Kansas, United States
- New Orleans, Louisiana, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Winston-Salem, North Carolina, United States
- Cincinnati, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
- Greenville, South Carolina, United States
- Sioux Falls, South Dakota, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
+ 33 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Fullerton, California, United States; San Francisco, California, United States; Aurora, Colorado, United States; New Haven, Connecticut, United States; Atlanta, Georgia, United States and 47 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.