{"preliminary_commentary":{"by_channel":{"x_thread":3},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":false},"commentary_summary":null,"drugs_tested":[["xaluritamig (AMG 509)"],["xaluritamig (AMG 509)","abiraterone"],["xaluritamig (AMG 509)","enzalutamide"]],"indication":"metastatic castration-resistant prostate cancer","name":"NCT04221542","nct_id":"NCT04221542","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct04221542. The price is an estimate of verified statements from the commentary indexed so far. Final coverage is set when the report is built. You never pay more than quoted: if the report is delivered at a smaller size, you pay that size's price, and anything paid above it is refunded. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_rule":"Never more than quoted: the buyer pays the smaller of price_usd and the price the delivered edition is sold at.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Part 1 will evaluate AMG 509 in participants with metastatic castration-resistant prostate cancer (mCRPC) who have been previously treated with novel hormonal therapy (NHT) and 1 to 2 prior taxanes.\n\nThe dose exploration phase of the study will estimate the maximum tolerated dose (MTD) of AMG 509 using a Bayesian logistic regression model (BLRM; Neuenschwander et al, 2008).\n\nRecommended phase 2 dose (RP2D) may be identified based on emerging safety, efficacy, PK, and pharmacodynamics (PD) data, as well as patient experience prior to reaching an MTD. Alternative dosing schedule(s) (including a third step dose) may be explored based on emerging efficacy, safety, PK data and patient experience.\n\nDuring the dose-expansion phase, individual cohorts of participants from China will be enrolled with a safety lead-in at 1 dose level below the MTD or RP2D followed by evaluation at the MTD or RP2D to confirm the safety, tolerability, MTD and/or RP2D of AMG 509 in Chinese participants.","label":"Part 1: AMG 509 Intravenous (IV) Monotherapy","type":"EXPERIMENTAL"},{"description":"Part 2 will explore the safety, tolerability, and PK of AMG 509 SC dosing in participants with mCRPC who have been previously treated with NHT and 1 to 2 prior taxanes.\n\nRecommended phase 2 dose for SC monotherapy may be identified based on emerging safety, efficacy, PK, and PD data, as well as patient experience prior to reaching an MTD.","label":"Part 2: AMG 509 Subcutaneous (SC) Monotherapy","type":"EXPERIMENTAL"},{"description":"Part 3 will explore AMG 509 in participants with mCRPC who have received no, or 1-2 prior NHTs (may have been given for hormone-sensitive prostate cancer \\[HSPC\\]) and no prior taxanes (unless administered in HSPC setting). This dose-expansion will be conducted to confirm safety, PK, and PD of AMG 509 at the MTD or RP2D determined in Part 1 dose exploration, and to obtain further safety and efficacy data and correlative biomarker analysis.","label":"Part 3: AMG 509 IV Monotherapy in Earlier Lines of Treatment","type":"EXPERIMENTAL"},{"description":"Part 4 will explore the safety, tolerability, and PK of AMG 509 for participants with mCRPC who have received no or 1 to 2 prior NHTs given in any disease setting depending on the part (dose-expansion phase: prior therapies including at least 1 prior NHT and either 0 or 1 prior poly-ADP ribose polymerase \\[PARP\\] inhibitor), at dose regimens previously determined to be safe and tolerable in Part 1, in combination with abiraterone acetate (Part 4A) or enzalutamide (Part 4B) and no or 1 prior taxane for hormone sensitive disease in Parts 4A and 4B.","label":"Part 4: AMG 509 IV Combination Therapy","type":"EXPERIMENTAL"},{"description":"Part 5 will evaluate the safety and tolerability of AMG 509 IV dosing in participants with mCRPC who have been previously treated with NHT and 1 to 2 prior taxanes, when administered in outpatient infusion centers.\n\nThe Part 5 dosing regimen and schedule was selected based on emerging data and dose level review team (DLRT) recommendations and will utilize the doses explored in Part 1 dose-expansion phase.","label":"Part 5: AMG 509 IV Monotherapy in Outpatient Setting","type":"EXPERIMENTAL"},{"description":"Part 6 will evaluate the preliminary efficacy, safety, tolerability, and PK of AMG 509 (alone or in combination with abiraterone acetate) for participants with mCRPC who have progressed on only 1 prior NHT (prior exposure to ≤ 6 cycles of taxane is allowed in mHSPC setting) and who have Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 measurable disease.\n\nPart 6 dosing regimen has been previously determined as safe and tolerable and is aligned with the dosing schedule for Parts 3 and 4A expansion.","label":"Part 6: AMG 509 IV as Monotherapy and Combination Therapy With Abiraterone Acetate","type":"EXPERIMENTAL"},{"description":"Part 7 will only include participants from China. This part will evaluate safety and tolerability of AMG 509 IV dosing in participants who have been previously treated with NHT and 1 to 2 prior taxanes.\n\nPart 7 dosing regime will first be enrolled to dose level-1 (1.0 mg target dose) and if tolerated and if DLRT determines it is safe to escalate to the MTD/RP2D, 1.5 mg every 2 weeks (Q2W) dosing regimen may be explored. If the RP2D is safe and tolerable and once AMG 509 monotherapy dose confirmation is complete, a cohort of participants to receive AMG 509 combination therapy with abiraterone acetate may be initiated.","label":"Part 7 (China only): AMG 509 IV as Monotherapy or in Combination With Abiraterone Acetate","type":"EXPERIMENTAL"}],"collaborators":["BeiGene","BeOne (China only)"],"completion_date":{"date":"2032-03-21","type":"ESTIMATED"},"conditions":["Prostate Cancer"],"enrollment":{"count":479,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"AMG 509","otherNames":["xaluritamig"],"type":"DRUG"},{"name":"Abiraterone","otherNames":[],"type":"DRUG"},{"name":"Enzalutamide","otherNames":[],"type":"DRUG"}],"last_update":"2026-08-21","lead_sponsor":"Amgen","official_title":"A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 509 in Subjects With Metastatic Castration-Resistant Prostate Cancer","overall_status":"RECRUITING","phases":["PHASE1"],"primary_completion_date":{"date":"2030-03-22","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Parts 1-5 and 7: Incidence of Treatment-emergent Adverse Events","timeFrame":"3 years"},{"measure":"Parts 1-5 and 7: Incidence of Treatment-related Adverse Events","timeFrame":"3 years"},{"measure":"Parts 1-5 and 7 Dose Exploration Cohorts Only: Dose Limiting Toxicities (DLTs)","timeFrame":"28 days"},{"measure":"Parts 1-5 and 7: Number of Participants with Changes in Vital Signs","timeFrame":"3 years"},{"measure":"Parts 1-5 and 7: Number of Participants with Changes in Electrocardiogram (ECG) Records","timeFrame":"3 years"},{"measure":"Parts 1-5 and 7: Number of Participants with Changes in Clinical Laboratory Test Results","timeFrame":"3 years"},{"measure":"Part 6: Objective Response (OR) per RECIST v1.1","timeFrame":"3 years"}],"references":[{"citation":"Kelly WK, Danila DC, Lin CC, Lee JL, Matsubara N, Ward PJ, Armstrong AJ, Pook D, Kim M, Dorff TB, Fischer S, Lin YC, Horvath LG, Sumey C, Yang Z, Jurida G, Smith KM, Connarn JN, Penny HL, Stieglmaier J, Appleman LJ. Xaluritamig, a STEAP1 x CD3 XmAb 2+1 Immune Therapy for Metastatic Castration-Resistant Prostate Cancer: Results from Dose Exploration in a First-in-Human Study. Cancer Discov. 2024 Jan 12;14(1):76-89. doi: 10.1158/2159-8290.CD-23-0964.","pmid":"37861461","type":"BACKGROUND"},{"citation":"Kuipers-Connarn JN, Pourzanjani A, Bose M, Modi S, Stieglmaier J, Murphy A, Mehta K, Upreti VV. Clinical Pharmacology Characterization and Dose Selection of Xaluritamig, a Next Generation XmAb(R) 2+1 T-Cell Engager, in Prostate Cancer Patients. J Clin Pharmacol. 2025 Dec;65(12):1676-1686. doi: 10.1002/jcph.70074. Epub 2025 Aug 5.","pmid":"40765197","type":"BACKGROUND"}],"start_date":{"date":"2020-03-04","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Study of AMG 509 in Participants With Metastatic Castration-Resistant Prostate Cancer","url":"https://clinicaltrials.gov/study/NCT04221542"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.2","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/nct04221542"}