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To evaluate the safety and tolerability of Tarlatamab and will determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Dose Exploration | Experimental | The maximum tolerated dose (MTD) will be estimated using isotonic regression (Ji et al, 2010). The recommended phase 2 dose (RP2D) may be identified based on emerging safety data prior to reaching an MTD. |
|
| Part 2: Dose Expansion | Experimental | Participants will receive the RP2D/MTD identified in Part 1 (dose exploration) of the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tarlatamab | Drug | Tarlatamab will be administered as an intravenous (IV) infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced One or More Treatment-emergent Adverse Events (TEAEs) | An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. A TEAE was defined as an AE starting on or after the first dose of tarlatamab, and up to and including 47 days after the last dose of tarlatamab excluding the events reported after End of Study date. Clinically significant changes from baseline in vital signs, 12-lead electrocardiograms (ECGs) and clinical laboratory tests were also reported as TEAEs. | Up to approximately 3 years |
| Number of Participants Who Experienced One or More Treatment-related Adverse Events (TRAE) | A TRAE was defined as a TEAE that per investigator review had a reasonable possibility of being caused by tarlatamab. Clinically significant changes from baseline in vital signs, 12-lead ECGs and clinical laboratory tests were also reported as TEAEs. | Up to approximately 3 years |
| Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) | A DLT was defined as any qualifying toxicity that was at least possibly related to tarlatamab with an onset within the first 28 days following first dose with either of the following criteria:
| Up to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | OR was assessed per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 with Prostate Cancer Working Group 3 (PCWG3) modifications. OR was defined as best overall response of partial response (PR) or complete response (CR) per RECIST 1.1, confirmed by an assessment at least 4 weeks later. Participants who did not experience a PR/CR or did not have any follow-up tumor assessments were regarded as non-responders. ORR was defined as the percentage of participants with a best overall response of confirmed CR or PR per RECIST 1.1. The percentage of participants with an OR was summarized along with the Clopper-Pearson (Clopper and Pearson, 1934) exact 95% confidence interval (CI). The result reported was evaluated by central reviewer assessment. |
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Inclusion Criteria (Part 1: Dose Exploration and Part 2: Dose Expansion):
Exclusion Criteria (Part 1: Dose Exploration and Part 2: Dose Expansion):
History of other malignancy within the past 2 years, with exceptions:
History or presence of hematological malignancies unless curatively treated with no evidence of disease ≥ 2 years
Untreated or symptomatic brain metastases and leptomeningeal disease
Anti-tumor therapy within 28 days of study day 1; concurrent use of hormone deprivation therapy for hormone refractory prostate cancer is permitted; participants on a stable bisphosphonate or denosumab prior to study day 1 are eligible
Exceptions:
Participants who received conventional chemotherapy are eligible if at least 14 days have elapsed and if all treatment-related toxicities have resolved to Grade ≤ 1
Prior palliative radiotherapy must have been completed at least 7 days before the first dose of tarlatamab
Participants who received androgen signaling inhibitor are eligible if at least 14 days have elapsed and if all treatment-related toxicity has been resolved to Grade ≤ 1
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Arizona | Phoenix | Arizona | 85054 | United States | ||
| University of California at San Francisco Helen Diller Family Comprehensive Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40689871 | Derived | Aggarwal R, Rottey S, Bernard-Tessier A, Mellado B, Kosaka T, Stadler WM, Horvath L, Greil R, O'Neil B, Siddiqui BA, Bauernhofer T, Bilen MA, Eskens F, Sandhu S, Shaw C, Ju CH, Decato BE, Yu B, Aparicio A. Safety and Efficacy of Tarlatamab in Patients with Neuroendocrine Prostate Cancer: Results from the Phase 1b DeLLpro-300 Study. Clin Cancer Res. 2025 Sep 15;31(18):3854-3863. doi: 10.1158/1078-0432.CCR-25-1211. |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
The planned Part 1 did not enrol participants. It was eliminated as pre-specified in the protocol due to sufficient data from Study 20160323 (NCT03319940) at the time of study initiation allowing the recommended phase 2 dose (RP2D) of tarlatamab to be determined for Part 2. Therefore no dose escalation occurred during the study.
A total of 41 participants were enrolled into this study in the United States, Australia, Austria, Belgium, France, Japan, Netherlands, and Spain between June 2021 and July 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tarlatamab Dose Expansion | Participants received tarlatamab as a short term IV infusion Q2W in a 28 day cycle until disease progression. All participants received the same target dose of tarlatamab which was reached using a step-dosing approach including a run-in dose on day 1 of the first cycle. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 21, 2024 | Jul 16, 2025 |
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| Up to approximately 3 years |
| Duration of Response (DOR) | DOR was defined as the time from the date of an initial objective response to the earlier of progressive disease or death for participants with an objective response per RECIST 1.1. DOR was assessed per RECIST 1.1 with PCWG3 modifications. The distribution of DOR was summarized using the Kaplan-Meier (KM) method with CI calculated using the Brookmeyer and Crowley (Brookmeyer and Crowley, 1982) method. The result reported was evaluated by central reviewer assessment. | Up to approximately 3 years |
| Radiographic Progression-free Survival (PFS) | Radiographic PFS was defined as the interval from the first dose of tarlatamab to the earlier of a radiographic progression or death from any cause. Radiographic PFS was assessed per RECIST 1.1 with PCWG3 modifications. The distribution of radiographic PFS was summarized using the KM method with CI calculated using the Brookmeyer and Crowley (Brookmeyer and Crowley, 1982) method. The result reported was evaluated by central reviewer assessment. | Up to approximately 3 years |
| Overall Survival (OS) | OS was defined as the time from the start of treatment until event of death due to any cause. The distribution of OS was summarized using the KM method with CI calculated using the Brookmeyer and Crowley (Brookmeyer and Crowley, 1982) method. | Up to approximately 3 years |
| Disease Control Rate (DCR) | DCR was defined as the percentage of participants with a best overall response of confirmed response (CR/PR) or stable disease (SD) as per RECIST 1.1. The DCR was assessed per RECIST 1.1. The percentage of participants with disease control with corresponding exact 95% CI was calculated using the Clopper-Pearson (Clopper and Pearson, 1934) method. The result reported was evaluated by central reviewer assessment. | Up to approximately 3 years |
| Maximum Serum Concentration (Cmax) of Tarlatamab | Pharmacokinetic (PK) parameters of tarlatamab were determined from the time concentration profile using standard non-compartmental approaches and considering the profile over the complete sampling interval. | Cycle 2 Day 1 and Day 15: Predose, end of infusion (EOI), 2, 6, 24, 48, 96 and 168 hours after EOI |
| Tarlatamab Concentration at the End of a Dosing Interval or Before Planned Next Dose (Ctrough) | PK parameters of tarlatamab were determined from the time concentration profile using standard non-compartmental approaches and considering the profile over the complete sampling interval. The result for this endpoint is given for cycle 2 only. | Cycle 2 Day 15: Predose |
| Area Under the Concentration-time Curve Over the Dosing Interval From Time 0 to 336 Hours (AUC336) of Tarlatamab | PK parameters of tarlatamab were determined from the time concentration profile using standard non-compartmental approaches and considering the profile over the complete sampling interval. The result for this endpoint is given for cycle 2 only. | Cycle 2 Day 1 and Day 15: Predose, EOI, 2, 6, 24, 48, 96, 168, and 336 hours after EOI |
| Terminal Phase Elimination Half-life (t1/2,z) of Tarlatamab | PK parameters of tarlatamab were determined from the time concentration profile using standard non-compartmental approaches and considering the profile over the complete sampling interval. The result for this endpoint is given for cycle 2 only. | Cycle 2 Day 15: Predose, EOI, 2, 6, 24, 48, 96 and 168 hours after EOI |
| San Francisco |
| California |
| 94158 |
| United States |
| Winship Cancer Institute of Emory University | Atlanta | Georgia | 30322 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Community Health Network MD Anderson Cancer Center - North | Indianapolis | Indiana | 46250 | United States |
| Washington University | St Louis | Missouri | 63110-1093 | United States |
| Weill Cornell Medical College | New York | New York | 10021 | United States |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27103 | United States |
| The Ohio State University | Columbus | Ohio | 43210 | United States |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Chris OBrien Lifehouse | Camperdown | New South Wales | 2050 | Australia |
| Peter MacCallum Cancer Centre | Melbourne | Victoria | 3000 | Australia |
| Medizinische Universitaet Graz | Graz | 8036 | Austria |
| Ordensklinikum Linz Elisabethinen | Linz | 4020 | Austria |
| Landeskrankenhaus Salzburg | Salzburg | 5020 | Austria |
| Universitair Ziekenhuis Gent | Ghent | 9000 | Belgium |
| Gustave Roussy | Villejuif | 94805 | France |
| Keio University Hospital | Shinjuku-ku | Tokyo | 160-8582 | Japan |
| Erasmus Medisch Centrum | Rotterdam | 3015 GD | Netherlands |
| Hospital Clinic i Provincial de Barcelona | Barcelona | Catalonia | 08036 | Spain |
| Royal Marsden Hospital | Sutton | SM2 5PT | United Kingdom |
| Participants Who Received Treatment |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
Safety Analysis Set: all participants who were enrolled and received at least 1 dose of tarlatamab.
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| ID | Title | Description |
|---|---|---|
| BG000 | Tarlatamab Dose Expansion | Participants received tarlatamab as a short term IV infusion Q2W in a 28 day cycle until disease progression. All participants received the same target dose of tarlatamab which was reached using a step-dosing approach including a run-in dose on day 1 of the first cycle. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Experienced One or More Treatment-emergent Adverse Events (TEAEs) | An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. A TEAE was defined as an AE starting on or after the first dose of tarlatamab, and up to and including 47 days after the last dose of tarlatamab excluding the events reported after End of Study date. Clinically significant changes from baseline in vital signs, 12-lead electrocardiograms (ECGs) and clinical laboratory tests were also reported as TEAEs. | Safety Analysis Set: all participants who were enrolled and received at least 1 dose of tarlatamab. | Posted | Count of Participants | Participants | Up to approximately 3 years |
|
|
| ||||||||||||||||||||||||||
| Primary | Number of Participants Who Experienced One or More Treatment-related Adverse Events (TRAE) | A TRAE was defined as a TEAE that per investigator review had a reasonable possibility of being caused by tarlatamab. Clinically significant changes from baseline in vital signs, 12-lead ECGs and clinical laboratory tests were also reported as TEAEs. | Safety Analysis Set: all participants who were enrolled and received at least 1 dose of tarlatamab. | Posted | Count of Participants | Participants | Up to approximately 3 years |
|
| |||||||||||||||||||||||||||
| Primary | Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) | A DLT was defined as any qualifying toxicity that was at least possibly related to tarlatamab with an onset within the first 28 days following first dose with either of the following criteria:
| DLT Analysis Set: all participants who were enrolled and received at least 1 dose of tarlatamab with an evaluable DLT endpoint. | Posted | Count of Participants | Participants | Up to 28 days |
|
| |||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) | OR was assessed per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 with Prostate Cancer Working Group 3 (PCWG3) modifications. OR was defined as best overall response of partial response (PR) or complete response (CR) per RECIST 1.1, confirmed by an assessment at least 4 weeks later. Participants who did not experience a PR/CR or did not have any follow-up tumor assessments were regarded as non-responders. ORR was defined as the percentage of participants with a best overall response of confirmed CR or PR per RECIST 1.1. The percentage of participants with an OR was summarized along with the Clopper-Pearson (Clopper and Pearson, 1934) exact 95% confidence interval (CI). The result reported was evaluated by central reviewer assessment. | Evaluable by Central Reviewer Analysis Set: all participants who were enrolled, received at least 1 dose of tarlatamab, had measurable baseline disease per RECIST 1.1 with PCWG3 modifications as assessed by a central reviewer. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 3 years |
|
| ||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) | DOR was defined as the time from the date of an initial objective response to the earlier of progressive disease or death for participants with an objective response per RECIST 1.1. DOR was assessed per RECIST 1.1 with PCWG3 modifications. The distribution of DOR was summarized using the Kaplan-Meier (KM) method with CI calculated using the Brookmeyer and Crowley (Brookmeyer and Crowley, 1982) method. The result reported was evaluated by central reviewer assessment. | Evaluable by Central Reviewer Analysis Set: all participants who were enrolled, received at least 1 dose of tarlatamab, had measurable baseline disease per RECIST 1.1 with PCWG3 modifications as assessed by a central reviewer. Only participants with a confirmed response have been included here. | Posted | Median | 95% Confidence Interval | months | Up to approximately 3 years |
|
| ||||||||||||||||||||||||||
| Secondary | Radiographic Progression-free Survival (PFS) | Radiographic PFS was defined as the interval from the first dose of tarlatamab to the earlier of a radiographic progression or death from any cause. Radiographic PFS was assessed per RECIST 1.1 with PCWG3 modifications. The distribution of radiographic PFS was summarized using the KM method with CI calculated using the Brookmeyer and Crowley (Brookmeyer and Crowley, 1982) method. The result reported was evaluated by central reviewer assessment. | Safety Analysis Set: all participants who were enrolled and received at least 1 dose of tarlatamab. Censoring was at the last evaluable disease assessment date (tumor assessment or bone scan). | Posted | Median | 95% Confidence Interval | months | Up to approximately 3 years |
|
| ||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS was defined as the time from the start of treatment until event of death due to any cause. The distribution of OS was summarized using the KM method with CI calculated using the Brookmeyer and Crowley (Brookmeyer and Crowley, 1982) method. | Safety Analysis Set: all participants who were enrolled and received at least 1 dose of tarlatamab. Among the 40 participants included in the Safety Analysis Set, 35 participants died because of any cause and 5 participants were censored. | Posted | Median | 95% Confidence Interval | months | Up to approximately 3 years |
|
| ||||||||||||||||||||||||||
| Secondary | Disease Control Rate (DCR) | DCR was defined as the percentage of participants with a best overall response of confirmed response (CR/PR) or stable disease (SD) as per RECIST 1.1. The DCR was assessed per RECIST 1.1. The percentage of participants with disease control with corresponding exact 95% CI was calculated using the Clopper-Pearson (Clopper and Pearson, 1934) method. The result reported was evaluated by central reviewer assessment. | Evaluable by Central Reviewer Analysis Set: all participants who were enrolled, received at least 1 dose of tarlatamab, had measurable baseline disease per RECIST 1.1 with PCWG3 modifications as assessed by a central reviewer. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 3 years |
|
| ||||||||||||||||||||||||||
| Secondary | Maximum Serum Concentration (Cmax) of Tarlatamab | Pharmacokinetic (PK) parameters of tarlatamab were determined from the time concentration profile using standard non-compartmental approaches and considering the profile over the complete sampling interval. | PK Analysis Set: all participants who received at least 1 dose of tarlatamab and had at least 1 PK sample collected. The total number of participants analyzed includes only participants with available data at pre-specified timepoints. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg/mL | Cycle 2 Day 1 and Day 15: Predose, end of infusion (EOI), 2, 6, 24, 48, 96 and 168 hours after EOI |
|
| ||||||||||||||||||||||||||
| Secondary | Tarlatamab Concentration at the End of a Dosing Interval or Before Planned Next Dose (Ctrough) | PK parameters of tarlatamab were determined from the time concentration profile using standard non-compartmental approaches and considering the profile over the complete sampling interval. The result for this endpoint is given for cycle 2 only. | PK Analysis Set: all participants who received at least 1 dose of tarlatamab and had at least 1 PK sample collected. The number of participants analyzed only includes participants with available data for each timepoint. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg/mL | Cycle 2 Day 15: Predose |
|
| ||||||||||||||||||||||||||
| Secondary | Area Under the Concentration-time Curve Over the Dosing Interval From Time 0 to 336 Hours (AUC336) of Tarlatamab | PK parameters of tarlatamab were determined from the time concentration profile using standard non-compartmental approaches and considering the profile over the complete sampling interval. The result for this endpoint is given for cycle 2 only. | PK Analysis Set: all participants who received at least 1 dose of tarlatamab and had at least 1 PK sample collected. The number of participants analyzed only includes participants with available data for each timepoint. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr*μg/mL | Cycle 2 Day 1 and Day 15: Predose, EOI, 2, 6, 24, 48, 96, 168, and 336 hours after EOI |
|
| ||||||||||||||||||||||||||
| Secondary | Terminal Phase Elimination Half-life (t1/2,z) of Tarlatamab | PK parameters of tarlatamab were determined from the time concentration profile using standard non-compartmental approaches and considering the profile over the complete sampling interval. The result for this endpoint is given for cycle 2 only. | PK Analysis Set: all participants who received at least 1 dose of tarlatamab and had at least 1 PK sample collected. The number of participants analyzed only includes participants with available data for each timepoint. | Posted | Geometric Mean | Geometric Coefficient of Variation | days | Cycle 2 Day 15: Predose, EOI, 2, 6, 24, 48, 96 and 168 hours after EOI |
|
|
Death - From enrollment until End of Study (EOS); Median (min, max) was 6.7 (0.1, 37.4) months. TEAE - from 1st study drug until min(last dose + 65 days, EOS); Median (min, max) duration was 3.6 (1.1, 37.3) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tarlatamab Dose Expansion | Participants received tarlatamab as a short term IV infusion Q2W in a 28 day cycle until disease progression. All participants received the same target dose of tarlatamab which was reached using a step-dosing approach including a run-in dose on day 1 of the first cycle. | 35 | 41 | 27 | 40 | 40 | 40 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial flutter | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Venoocclusive liver disease | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Immobilisation syndrome | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Neuroendocrine cancer of the prostate metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Neuroendocrine carcinoma of prostate | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Prostate cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Immune-mediated encephalopathy | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Neurotoxicity | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Bladder obstruction | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
|
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 | medinfo@amgen.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 24, 2023 | Jul 16, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| C000722655 | AMG 757 |
Not provided
Not provided
Not provided
| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Participants |
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