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NCT04221542

Study of AMG 509 in Participants With Metastatic Castration-Resistant Prostate Cancer

StatusRecruiting
PhasePhase 1
SponsorAmgen
Primary completion (estimated)

At risk: Primary completion moved at least 4 months later.

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Record History

The 50 most recent of 79 versions: 45 with changes below, 5 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 31 words Show 6 more changesShow less
    • Primary completion pushed from Mar 22, 2030 to Jul 28, 2030
    • Trial sites reduced: 57 → 54 locations
    • Study completion pushed from Mar 21, 2032 to Jul 29, 2032
    • Enrollment target: 479 to 505
    • Secondary endpoints: details revised at 6 of 32 entries
    • Publications: details revised at 2 of 2 entries
  2. Site details revised at 1 of 57 sitesv78
  3. Site details revised at 1 of 57 sitesv77
  4. Study sites revised (57)v76
  5. Study sites revised (57)v75
Show 40 earlier versionsHide 40 earlier versions
  1. Study sites: 56 to 57v74
  2. Study sites: 55 to 56v73
  3. Study sites: 54 to 55v72
  4. Primary completion date: Mar 5, 2030 to Mar 22, 2030
    • Study completion date: Mar 4, 2032 to Mar 21, 2032
    • Study sites revised (54)
    v71
  5. Primary completion date: Feb 14, 2026 to Mar 5, 2030v68 Show 8 more changesShow less
    • Eligibility criteria expanded, about 158 words
    • Primary endpoints: 6 to 7
    • Enrollment target: 470 to 479
    • Study completion date: Aug 17, 2028 to Mar 4, 2032
    • Secondary endpoints: 22 to 32
    • Publications: 1 to 2
    • Study arms: 5 to 7
    • Collaborators expanded, about 4 words
  6. Study completion date: Aug 15, 2028 to Aug 17, 2028
    • Study sites revised (54)
    v67
  7. Study sites: 52 to 54v66
  8. Primary completion date: Apr 15, 2026 to Feb 14, 2026
    • Study completion date: Aug 17, 2028 to Aug 15, 2028
    • Study sites revised (52)
    v65
  9. Eligibility criteria expanded, about 30 words
    • Enrollment target: 461 to 470
    • Study completion date: Jul 30, 2028 to Aug 17, 2028
    v63
  10. Study sites revised (52)v62
  11. Study sites: 51 to 52v61
  12. Study sites: 50 to 51v60
  13. Eligibility criteria expanded, about 164 words
    • Study sites: 49 to 50
    v58
  14. Study sites revised (49)v57
  15. Study sites: 47 to 49v56
  16. Study sites: 45 to 47v55
  17. Publications expanded, about 71 wordsv54
  18. Study sites: 44 to 45
    • Primary completion date: Apr 8, 2026 to Apr 15, 2026
    v53
  19. Study sites: 43 to 44v52
  20. Primary completion date: Mar 29, 2026 to Apr 8, 2026
    • Study sites revised (43)
    v51
  21. Study sites: 40 to 43
    • Publications shortened, about 71 words
    v50
  22. Publications expanded, about 71 wordsv49
  23. Eligibility criteria expanded, about 146 words
    • Enrollment target: 441 to 461
    • Study sites: 39 to 40
    v48
  24. Study sites: 38 to 39
    • Study completion date: Mar 30, 2028 to Jul 30, 2028
    v47
  25. Study sites: 37 to 38
    • Primary completion date: Jun 29, 2026 to Mar 29, 2026
    • Study completion date: Jun 29, 2028 to Mar 30, 2028
    v46
  26. Study sites revised (37)v45
  27. Study sites: 36 to 37v44
  28. Eligibility criteria shortened, about 40 words
    • Enrollment target: 464 to 441
    • Study sites: 33 to 36
    • Interventions: AMG 509 (Drug), Abiraterone (Drug), Docetaxel (Drug), Enzalutamide (Drug) to AMG 509 (Drug), Abiraterone (Drug), Enzalutamide (Drug)
    v43
  29. Study sites: 32 to 33v42
  30. Study sites: 31 to 32v40
  31. Study sites: 28 to 31v39
  32. Study sites: 27 to 28v38
  33. Study sites: 26 to 27v37
  34. Study sites: 25 to 26v36
  35. Study sites revised (25)v35
  36. Study sites: 24 to 25v34
  37. Study sites: 23 to 24v33
  38. Primary completion date: Nov 9, 2025 to Jun 29, 2026v32 Show 6 more changesShow less
    • Eligibility criteria shortened, about 4 words
    • Enrollment target: 459 to 464
    • Study completion date: Nov 11, 2027 to Jun 29, 2028
    • Interventions: AMG 509 (Drug), Abiraterone (Drug), Enzalutamide (Drug), Pembrolizumab (Biological) to AMG 509 (Drug), Abiraterone (Drug), Docetaxel (Drug), Enzalutamide (Drug)
    • Secondary endpoints: 19 to 22
    • Study title revised
  39. Study sites: 22 to 23
    • Primary completion date: Aug 8, 2025 to Nov 9, 2025
    • Study completion date: Aug 9, 2027 to Nov 11, 2027
    v31
  40. Study sites: 21 to 22v30
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Parts 1-5 and 7: Incidence of Treatment-emergent Adverse Events
Timeframe: 3 years
Parts 1-5 and 7: Incidence of Treatment-related Adverse Events
Timeframe: 3 years
Parts 1-5 and 7 Dose Exploration Cohorts Only: Dose Limiting Toxicities (DLTs)
Timeframe: 28 days
Parts 1-5 and 7: Number of Participants with Changes in Vital Signs
Timeframe: 3 years
Parts 1-5 and 7: Number of Participants with Changes in Electrocardiogram (ECG) Records
Timeframe: 3 years
Parts 1-5 and 7: Number of Participants with Changes in Clinical Laboratory Test Results
Timeframe: 3 years
Part 6: Objective Response (OR) per RECIST v1.1
Timeframe: 3 years

Secondary (32)

Parts 1-7: Maximum Serum Concentration (Cmax) for AMG 509
Parts 1-7: Time to Maximum Serum Concentration (Tmax) for AMG 509
Parts 1-7: Minimum Serum Concentration (Cmin) for AMG 509
Parts 1-7: Area Under the Concentration-time Curve (AUC) Over the Dosing Interval for AMG 509
Parts 1-7: Accumulation Following Multiple Dosing for AMG 509
Show 27 moreShow less
Parts 1-5 and 7: OR per RECIST v1.1
Parts 1-7: Prostate Specific Antigen (PSA) Response
Parts 1-5 and 7: PSA Decline of at Least 50% From Baseline at 12 Weeks
Parts 1-7: Radiographic Duration of Response (DOR)
Parts 1-5 and 7: PSA DOR
Parts 1-5 and 7: Radiographic Time to Progression
Parts 1-5 and 7: PSA Time to Progression
Parts 1-5 and 7: Radiographic Progression-free Survival (PFS)
Parts 1-5 and 7: PSA PFS
Part 6: Radiographic PFS per Prostate Cancer Working Group 3 (PCWG3)-modified RECIST v1.1
Parts 1-2, 5 and 7: 6 Month Radiographic PFS
Part 3 and 4: 1, 2, and 3-year Radiographic PFS
Parts 1-5: 1, 2, and 3-year Overall Survival (OS)
Parts 1-5: Circulating Tumor Cells Response (CTC0)
Parts 1-5: Rate of Circulating Tumor Cells (CTC) Conversion
Parts 1-5: Time to Symptomatic Skeletal Events
Parts 1-5: Alkaline Phosphatase (Total, Bone)
Parts 1-5: Lactate Dehydrogenase (LDH)
Parts 1-5: Hemoglobin
Parts 1-5: Urine N-telopeptide
Parts 1-5: Neutrophil-to-lymphocyte Ratio
Part 6: Incidence of Treatment-emergent Adverse Events
Part 6: Incidence of Treatment-related Adverse Events
Part 6: Number of Participants with Changes in Vital Signs
Part 6: Number of Participants with Changes in Clinical Laboratory Test Results
Part 6: Disease Control per RECIST v1.1
Parts 6 and 7: OS

Arms and interventions

Part 1: AMG 509 Intravenous (IV) MonotherapyExperimental

Participants with metastatic castration-resistant prostate cancer (mCRPC) receive AMG 509 (xaluritamig) by short-term IV infusion.

Part 2: AMG 509 Subcutaneous (SC) MonotherapyExperimental

Participants with mCRPC receive AMG 509 by SC injection.

Part 3: AMG 509 IV Monotherapy in Earlier Lines of TreatmentExperimental

Participants with mCRPC receive AMG 509 by IV infusion.

Part 4: AMG 509 IV Combination TherapyExperimental

Participants with mCRPC receive AMG 509 by IV infusion with either oral abiraterone acetate (Part 4A), or oral enzalutamide (Part 4B).

Part 5: AMG 509 IV Monotherapy in Outpatient SettingExperimental

Participants with mCRPC receive AMG 509 by IV infusion in an outpatient infusion setting.

Part 6: AMG 509 IV as Monotherapy and Combination Therapy With Abiraterone AcetateExperimental

Participants with mCRPC and measurable disease are randomized 1:1 to receive either AMG 509 by IV infusion or AMG 509 with oral abiraterone acetate.

Part 7 (China only): AMG 509 IV as Monotherapy or in Combination With Abiraterone AcetateExperimental

Participants in China receive AMG 509 by IV infusion as monotherapy or, if the combination cohort is initiated, with oral abiraterone acetate.

Drugs: AMG 509, Abiraterone, Enzalutamide

Sites

54 sites in 10 countries

United States 23, China 7, Spain 5, Germany 4, Japan 3, Portugal 3, Switzerland 3, Australia 2, South Korea 2, Taiwan 2