Trial Outcomes & Findings for A Study of AMG 757 in Participants With Neuroendocrine Prostate Cancer (NCT NCT04702737)

Last Updated: 2025-09-12

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

41 participants

Primary outcome timeframe

Up to approximately 3 years

Results posted on

2025-09-12

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	41
Overall Study Participants Who Received Treatment	40
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	40

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Decision by Sponsor	1
Overall Study Withdrawal of Consent from Study	3
Overall Study Lost to Follow-up	1
Overall Study Death	35

Baseline Characteristics

A Study of AMG 757 in Participants With Neuroendocrine Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tarlatamab Dose Expansion n=40 Participants 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.
Age, Continuous	64 years STANDARD_DEVIATION 9.1 • n=93 Participants
Sex: Female, Male Female	0 Participants n=93 Participants
Sex: Female, Male Male	40 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	27 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	11 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	3 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	29 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	8 Participants n=93 Participants

PRIMARY outcome

Timeframe: Up to approximately 3 years

Population: Safety Analysis Set: all participants who were enrolled and received at least 1 dose of tarlatamab.

Outcome measures

Outcome measures
Measure	Tarlatamab Dose Expansion n=40 Participants 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.
Number of Participants Who Experienced One or More Treatment-emergent Adverse Events (TEAEs)	40 Participants

PRIMARY outcome

Timeframe: Up to approximately 3 years

Population: Safety Analysis Set: all participants who were enrolled and received at least 1 dose of tarlatamab.

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.

Outcome measures

Outcome measures
Measure	Tarlatamab Dose Expansion n=40 Participants 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.
Number of Participants Who Experienced One or More Treatment-related Adverse Events (TRAE)	40 Participants

PRIMARY outcome

Timeframe: Up to 28 days

Population: DLT Analysis Set: all participants who were enrolled and received at least 1 dose of tarlatamab with an evaluable DLT endpoint.

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: 1. Grade 3 adverse event lasting more than 3 days (with the exception of fatigue and Grade 3 non-febrile neutropenia that improved to ≤ Grade 1 within 3 weeks including the use of growth factor support per neutropenia management guidelines); 2. ≥ Grade 4 adverse event regardless of duration (with the exception of grade 4 non-febrile neutropenia lasting less than or equal to 7 days including the use of growth factor support per neutropenia management guidelines).

Outcome measures

Outcome measures
Measure	Tarlatamab Dose Expansion n=30 Participants 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.
Number of Participants Who Experienced Dose Limiting Toxicities (DLTs)	1 Participants

SECONDARY outcome

Timeframe: Up to approximately 3 years

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Tarlatamab Dose Expansion n=25 Participants 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.
Objective Response Rate (ORR)	12.0 percentage of participants Interval 2.5 to 31.2

SECONDARY outcome

Timeframe: Up to approximately 3 years

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.

Outcome measures

Outcome measures
Measure	Tarlatamab Dose Expansion n=3 Participants 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.
Duration of Response (DOR)	NA months The median KM DOR and 95% confidence interval could not be estimated due to all responders being censored.

SECONDARY outcome

Timeframe: Up to approximately 3 years

Population: 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).

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.

Outcome measures

Outcome measures
Measure	Tarlatamab Dose Expansion n=40 Participants 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.
Radiographic Progression-free Survival (PFS)	2.1 months Interval 1.8 to 3.8

SECONDARY outcome

Timeframe: Up to approximately 3 years

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Tarlatamab Dose Expansion n=40 Participants 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.
Overall Survival (OS)	7.9 months Interval 4.4 to 13.2

SECONDARY outcome

Timeframe: Up to approximately 3 years

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.

Outcome measures

Outcome measures
Measure	Tarlatamab Dose Expansion n=25 Participants 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.
Disease Control Rate (DCR)	36.0 percentage of participants Interval 18.0 to 57.5

SECONDARY outcome

Timeframe: Cycle 2 Day 1 and Day 15: Predose, end of infusion (EOI), 2, 6, 24, 48, 96 and 168 hours after EOI

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Tarlatamab Dose Expansion n=25 Participants 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.
Maximum Serum Concentration (Cmax) of Tarlatamab Cycle 2 Day 15	31.7 μg/mL Geometric Coefficient of Variation 19
Maximum Serum Concentration (Cmax) of Tarlatamab Cycle 2 Day 1	31.1 μg/mL Geometric Coefficient of Variation 26

SECONDARY outcome

Timeframe: Cycle 2 Day 15: Predose

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Tarlatamab Dose Expansion n=21 Participants 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.
Tarlatamab Concentration at the End of a Dosing Interval or Before Planned Next Dose (Ctrough)	5.36 μg/mL Geometric Coefficient of Variation 36

SECONDARY outcome

Timeframe: Cycle 2 Day 1 and Day 15: Predose, EOI, 2, 6, 24, 48, 96, 168, and 336 hours after EOI

Outcome measures

Outcome measures
Measure	Tarlatamab Dose Expansion n=25 Participants 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.
Area Under the Concentration-time Curve Over the Dosing Interval From Time 0 to 336 Hours (AUC336) of Tarlatamab Cycle 2 Day 1	4010 hr*μg/mL Geometric Coefficient of Variation 28
Area Under the Concentration-time Curve Over the Dosing Interval From Time 0 to 336 Hours (AUC336) of Tarlatamab Cycle 2 Day 15	4260 hr*μg/mL Geometric Coefficient of Variation 26

SECONDARY outcome

Timeframe: Cycle 2 Day 15: Predose, EOI, 2, 6, 24, 48, 96 and 168 hours after EOI

Outcome measures

Outcome measures
Measure	Tarlatamab Dose Expansion n=21 Participants 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.
Terminal Phase Elimination Half-life (t1/2,z) of Tarlatamab	7.23 days Geometric Coefficient of Variation 33

Adverse Events

Tarlatamab Dose Expansion

Serious events: 27 serious events

Other events: 40 other events

Deaths: 35 deaths

Serious adverse events

Serious adverse events
Measure	Tarlatamab Dose Expansion n=40 participants at risk 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.
Cardiac disorders Atrial flutter	2.5% 1/40 • 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.
Cardiac disorders Supraventricular tachycardia	2.5% 1/40 • 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.
Cardiac disorders Tachycardia	2.5% 1/40 • 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.
Gastrointestinal disorders Dysphagia	2.5% 1/40 • 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.
Gastrointestinal disorders Large intestine perforation	2.5% 1/40 • 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.
Gastrointestinal disorders Rectal haemorrhage	2.5% 1/40 • 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.
Gastrointestinal disorders Stomatitis	2.5% 1/40 • 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.
General disorders Fatigue	10.0% 4/40 • 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.
General disorders Pain	2.5% 1/40 • 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.
Hepatobiliary disorders Venoocclusive liver disease	2.5% 1/40 • 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.
Immune system disorders Cytokine release syndrome	22.5% 9/40 • 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.
Infections and infestations Infection	2.5% 1/40 • 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.
Infections and infestations Pneumonia	2.5% 1/40 • 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.
Infections and infestations Pneumonia aspiration	2.5% 1/40 • 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.
Infections and infestations Sepsis	5.0% 2/40 • 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.
Injury, poisoning and procedural complications Head injury	2.5% 1/40 • 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.
Metabolism and nutrition disorders Hyponatraemia	2.5% 1/40 • 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.
Musculoskeletal and connective tissue disorders Bone pain	2.5% 1/40 • 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.
Musculoskeletal and connective tissue disorders Immobilisation syndrome	2.5% 1/40 • 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.
Musculoskeletal and connective tissue disorders Muscular weakness	2.5% 1/40 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	2.5% 1/40 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine cancer of the prostate metastatic	5.0% 2/40 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine carcinoma of prostate	12.5% 5/40 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	5.0% 2/40 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer metastatic	10.0% 4/40 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	2.5% 1/40 • 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.
Nervous system disorders Epilepsy	2.5% 1/40 • 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.
Nervous system disorders Immune-mediated encephalopathy	2.5% 1/40 • 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.
Nervous system disorders Neurotoxicity	2.5% 1/40 • 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.
Nervous system disorders Paraesthesia	2.5% 1/40 • 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.
Nervous system disorders Presyncope	2.5% 1/40 • 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.
Nervous system disorders Tremor	2.5% 1/40 • 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.
Psychiatric disorders Confusional state	2.5% 1/40 • 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.
Psychiatric disorders Mental status changes	2.5% 1/40 • 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.
Psychiatric disorders Restlessness	2.5% 1/40 • 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.
Renal and urinary disorders Acute kidney injury	7.5% 3/40 • 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.
Renal and urinary disorders Bladder obstruction	2.5% 1/40 • 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.
Renal and urinary disorders Haematuria	2.5% 1/40 • 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.
Renal and urinary disorders Hydronephrosis	2.5% 1/40 • 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.
Renal and urinary disorders Renal impairment	2.5% 1/40 • 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.
Vascular disorders Deep vein thrombosis	2.5% 1/40 • 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.

Other adverse events

Other adverse events
Measure	Tarlatamab Dose Expansion n=40 participants at risk 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.
Blood and lymphatic system disorders Anaemia	35.0% 14/40 • 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.
Cardiac disorders Atrial fibrillation	5.0% 2/40 • 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.
Cardiac disorders Sinus tachycardia	7.5% 3/40 • 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.
Cardiac disorders Tachycardia	7.5% 3/40 • 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.
Endocrine disorders Hypothyroidism	5.0% 2/40 • 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.
Gastrointestinal disorders Abdominal pain	12.5% 5/40 • 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.
Gastrointestinal disorders Abdominal pain upper	5.0% 2/40 • 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.
Gastrointestinal disorders Constipation	45.0% 18/40 • 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.
Gastrointestinal disorders Diarrhoea	22.5% 9/40 • 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.
Gastrointestinal disorders Dry mouth	5.0% 2/40 • 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.
Gastrointestinal disorders Dyspepsia	10.0% 4/40 • 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.
Gastrointestinal disorders Gastrooesophageal reflux disease	5.0% 2/40 • 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.
Gastrointestinal disorders Haemorrhoids	5.0% 2/40 • 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.
Gastrointestinal disorders Nausea	32.5% 13/40 • 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.
Gastrointestinal disorders Vomiting	27.5% 11/40 • 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.
General disorders Asthenia	10.0% 4/40 • 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.
General disorders Chills	12.5% 5/40 • 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.
General disorders Fatigue	40.0% 16/40 • 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.
General disorders Gait disturbance	5.0% 2/40 • 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.
General disorders Malaise	5.0% 2/40 • 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.
General disorders Oedema peripheral	7.5% 3/40 • 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.
General disorders Pain	5.0% 2/40 • 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.
General disorders Pyrexia	40.0% 16/40 • 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.
Immune system disorders Cytokine release syndrome	65.0% 26/40 • 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.
Infections and infestations COVID-19	7.5% 3/40 • 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.
Infections and infestations Nasopharyngitis	5.0% 2/40 • 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.
Infections and infestations Urinary tract infection	12.5% 5/40 • 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.
Injury, poisoning and procedural complications Contusion	5.0% 2/40 • 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.
Injury, poisoning and procedural complications Fall	10.0% 4/40 • 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.
Investigations Alanine aminotransferase increased	7.5% 3/40 • 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.
Investigations Aspartate aminotransferase increased	12.5% 5/40 • 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.
Investigations Blood creatine phosphokinase increased	5.0% 2/40 • 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.
Investigations Blood creatinine increased	7.5% 3/40 • 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.
Investigations C-reactive protein increased	5.0% 2/40 • 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.
Investigations Electrocardiogram QT prolonged	7.5% 3/40 • 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.
Investigations Lymphocyte count decreased	7.5% 3/40 • 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.
Investigations Weight decreased	12.5% 5/40 • 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.
Metabolism and nutrition disorders Decreased appetite	50.0% 20/40 • 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.
Metabolism and nutrition disorders Hypokalaemia	15.0% 6/40 • 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.
Metabolism and nutrition disorders Hypomagnesaemia	5.0% 2/40 • 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.
Metabolism and nutrition disorders Hyponatraemia	20.0% 8/40 • 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.
Metabolism and nutrition disorders Hypophosphataemia	10.0% 4/40 • 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.
Musculoskeletal and connective tissue disorders Arthralgia	7.5% 3/40 • 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.
Musculoskeletal and connective tissue disorders Back pain	20.0% 8/40 • 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.
Musculoskeletal and connective tissue disorders Muscle spasms	5.0% 2/40 • 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.
Musculoskeletal and connective tissue disorders Myalgia	10.0% 4/40 • 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.
Musculoskeletal and connective tissue disorders Pain in extremity	7.5% 3/40 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	10.0% 4/40 • 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.
Nervous system disorders Aphasia	5.0% 2/40 • 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.
Nervous system disorders Dizziness	7.5% 3/40 • 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.
Nervous system disorders Dysgeusia	42.5% 17/40 • 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.
Nervous system disorders Headache	25.0% 10/40 • 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.
Nervous system disorders Neuralgia	7.5% 3/40 • 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.
Nervous system disorders Paraesthesia	5.0% 2/40 • 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.
Nervous system disorders Somnolence	5.0% 2/40 • 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.
Nervous system disorders Tremor	12.5% 5/40 • 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.
Psychiatric disorders Anxiety	10.0% 4/40 • 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.
Psychiatric disorders Confusional state	10.0% 4/40 • 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.
Psychiatric disorders Insomnia	7.5% 3/40 • 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.
Psychiatric disorders Restlessness	5.0% 2/40 • 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.
Renal and urinary disorders Dysuria	10.0% 4/40 • 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.
Renal and urinary disorders Haematuria	5.0% 2/40 • 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.
Renal and urinary disorders Pollakiuria	12.5% 5/40 • 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.
Renal and urinary disorders Urinary retention	17.5% 7/40 • 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.
Reproductive system and breast disorders Pelvic pain	7.5% 3/40 • 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.
Respiratory, thoracic and mediastinal disorders Hypoxia	5.0% 2/40 • 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.
Skin and subcutaneous tissue disorders Dry skin	5.0% 2/40 • 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.
Skin and subcutaneous tissue disorders Erythema	5.0% 2/40 • 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.
Skin and subcutaneous tissue disorders Pruritus	7.5% 3/40 • 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.
Skin and subcutaneous tissue disorders Rash maculo-papular	12.5% 5/40 • 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.
Vascular disorders Embolism	5.0% 2/40 • 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.
Vascular disorders Hypertension	7.5% 3/40 • 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.
Vascular disorders Hypotension	10.0% 4/40 • 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.
Vascular disorders Orthostatic hypotension	5.0% 2/40 • 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.

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER