Trial · NCT04702737
A Study of AMG 757 in Participants With Neuroendocrine Prostate Cancer
NCT04702737, Phase 1, Completed, Amgen; results first posted 2025-09-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of AMG 757 in Participants With Neuroendocrine Prostate Cancer. Trials, record NCT04702737. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04702737
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of AMG 757 in Participants With Neuroendocrine Prostate Cancer
- NCT number
- NCT04702737
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 41 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Neuroendocrine Prostate Cancer
- Interventions
- Tarlatamab
- First posted
- 2021-01-11
- Last updated
- 2025-09-12
- Results first posted
- 2025-09-12
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Experienced One or More Treatment-emergent Adverse Events (TEAEs) | Up to approximately 3 years | 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. |
| Primary | Number of Participants Who Experienced One or More Treatment-related Adverse Events (TRAE) | Up to approximately 3 years | 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. |
| Primary | Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) | Up to 28 days | 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). |
| Secondary | Objective Response Rate (ORR) | Up to approximately 3 years | 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. |
| Secondary | Duration of Response (DOR) | 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. |
| Secondary | Radiographic Progression-free Survival (PFS) | Up to approximately 3 years | 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. |
| Secondary | Overall Survival (OS) | Up to approximately 3 years | 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. |
| Secondary | Disease Control Rate (DCR) | 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. |
| Secondary | Maximum Serum Concentration (Cmax) of Tarlatamab | Cycle 2 Day 1 and Day 15: Predose, end of infusion (EOI), 2, 6, 24, 48, 96 and 168 hours after EOI | 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. |
| Secondary | Tarlatamab Concentration at the End of a Dosing Interval or Before Planned Next Dose (Ctrough) | Cycle 2 Day 15: Predose | 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. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who Experienced One or More Treatment-emergent Adverse Events (TEAEs) | Up to approximately 3 years | Safety Analysis Set: all participants who were enrolled and received at least 1 dose of tarlatamab. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Who Experienced One or More Treatment-related Adverse Events (TRAE) | Up to approximately 3 years | Safety Analysis Set: all participants who were enrolled and received at least 1 dose of tarlatamab. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) | Up to 28 days | DLT Analysis Set: all participants who were enrolled and received at least 1 dose of tarlatamab with an evaluable DLT endpoint. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Objective Response Rate (ORR) | Up to approximately 3 years | 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. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) | Up to approximately 3 years | 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. | months | MEDIAN |
| SECONDARY | Radiographic Progression-free Survival (PFS) | Up to approximately 3 years | 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). | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Up to approximately 3 years | 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. | months | MEDIAN |
| SECONDARY | Disease Control Rate (DCR) | Up to approximately 3 years | 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. | percentage of participants | NUMBER |
| SECONDARY | Maximum Serum Concentration (Cmax) of Tarlatamab | Cycle 2 Day 1 and Day 15: Predose, end of infusion (EOI), 2, 6, 24, 48, 96 and 168 hours after EOI | 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. | μg/mL | GEOMETRIC_MEAN |
| SECONDARY | Tarlatamab Concentration at the End of a Dosing Interval or Before Planned Next Dose (Ctrough) | Cycle 2 Day 15: Predose | 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. | μg/mL | GEOMETRIC_MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Who Experienced One or More Treatment-emergent Adverse Events (TEAEs) | Tarlatamab Dose Expansion | 40 | Participants | ||
| Number of Participants Who Experienced One or More Treatment-related Adverse Events (TRAE) | Tarlatamab Dose Expansion | 40 | Participants | ||
| Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) | Tarlatamab Dose Expansion | 1 | Participants | ||
| Objective Response Rate (ORR) | Tarlatamab Dose Expansion | 12.0 | 95% Confidence Interval 2.5 to 31.2 | percentage of participants | |
| Duration of Response (DOR) | Tarlatamab Dose Expansion | NA | 95% Confidence Interval NA to NA | months | |
| Radiographic Progression-free Survival (PFS) | Tarlatamab Dose Expansion | 2.1 | 95% Confidence Interval 1.8 to 3.8 | months | |
| Overall Survival (OS) | Tarlatamab Dose Expansion | 7.9 | 95% Confidence Interval 4.4 to 13.2 | months | |
| Disease Control Rate (DCR) | Tarlatamab Dose Expansion | 36.0 | 95% Confidence Interval 18.0 to 57.5 | percentage of participants | |
| Maximum Serum Concentration (Cmax) of Tarlatamab | Tarlatamab Dose Expansion | Cycle 2 Day 1 | 31.1 | Geometric Coefficient of Variation 26 | μg/mL |
| Maximum Serum Concentration (Cmax) of Tarlatamab | Tarlatamab Dose Expansion | Cycle 2 Day 15 | 31.7 | Geometric Coefficient of Variation 19 | μg/mL |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tarlatamab Dose Expansion | 41 | |
| Overall Study | Participants Who Received Treatment | Tarlatamab Dose Expansion | 40 | |
| Overall Study | COMPLETED | Tarlatamab Dose Expansion | 1 | |
| Overall Study | NOT COMPLETED | Tarlatamab Dose Expansion | 40 |
Source ClinicalTrials.gov
Adverse events115
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Tarlatamab Dose Expansion | 14 | 40 | |
| other | Atrial fibrillation | Cardiac disorders | Tarlatamab Dose Expansion | 2 | 40 | |
| other | Sinus tachycardia | Cardiac disorders | Tarlatamab Dose Expansion | 3 | 40 | |
| other | Tachycardia | Cardiac disorders | Tarlatamab Dose Expansion | 3 | 40 | |
| other | Hypothyroidism | Endocrine disorders | Tarlatamab Dose Expansion | 2 | 40 | |
| other | Abdominal pain | Gastrointestinal disorders | Tarlatamab Dose Expansion | 5 | 40 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Tarlatamab Dose Expansion | 2 | 40 | |
| other | Constipation | Gastrointestinal disorders | Tarlatamab Dose Expansion | 18 | 40 | |
| other | Diarrhoea | Gastrointestinal disorders | Tarlatamab Dose Expansion | 9 | 40 | |
| other | Dry mouth | Gastrointestinal disorders | Tarlatamab Dose Expansion | 2 | 40 |
1 to 10 of 115Source ClinicalTrials.gov
See all 115 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tarlatamab Dose Expansion | 35 | 41 |
| Total, other adverse events | Tarlatamab Dose Expansion | 40 | 40 |
| Total, serious adverse events | Tarlatamab Dose Expansion | 27 | 40 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40689871 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04702737
GET https://conductscience.org/api/trials/v1/NCT04702737/events?page=2