Evidence map›Paper›PMID 40689871›Full record

ArticleClinical cancer research : an official journal of the American Association for Cancer Research2025

Safety and Efficacy of Tarlatamab in Patients with Neuroendocrine Prostate Cancer: Results from the Phase 1b DeLLpro-300 Study.

Rahul Aggarwal, Sylvie Rottey, Alice Bernard-Tessier, Begoña Mellado, Takeo Kosaka, Walter M Stadler, Lisa Horvath, Richard Greil, Bert O'Neil, Bilal A Siddiqui and 9 more

Registry-linked trialAbstract readClinical Trial, Phase IMulticenter Study
In one paragraph

Article in Clinical cancer research : an official journal of the American Association for Cancer Research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04702737 (A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of Delta-like Protein 3 Half-life Extended Bispecific T-cell Engager AMG 757 in Subjects With De Novo or Treatment Emergent Neuroendocrine Prostate Cancer), which is not on this map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04702737 phase1completednot on this map

A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of Delta-like Protein 3 Half-life Extended Bispecific T-cell Engager AMG 757 in Subjects With De Novo or Treatment Emergent Neuroendocrine Prostate Cancer

TypeinterventionalSponsorAmgenRan2021 to 2024Enrolled41ConditionsNeuroendocrine Prostate CancerArmsTarlatamab
3 · Its place in the literature

Who cites it

16 citing papers in PubMed.

  1. Article
  2. Review
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  4. Article
  5. Advances in Cancer Immunotherapy for Solid Tumors.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026
    Review
  6. Article
  7. Review
  8. Review
  9. Review
  10. Review
  11. Article
  12. Review
  13. Review
  14. The Olive PhenolicCancers · 2025
    Article
  15. Review
  16. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors.

Rahul AggarwalDivision of Hematology/Oncology, University of California San Francisco, San Francisco, California.ORCID 0000-0001-7003-7982
Sylvie RotteyDepartment of Medical Oncology, Ghent University Hospital, Ghent, Belgium.ORCID 0000-0003-2060-3725
Alice Bernard-TessierDepartment of Cancer Medicine, Gustave Roussy Cancer Campus, Villejuif, France.ORCID 0000-0001-9706-3945
Begoña MelladoMedical Oncology Department, Hospital Clínic de Barcelona, University of Barcelona, IDIBAPS, Barcelona, Spain.ORCID 0000-0002-8088-5966
Takeo KosakaDepartment of Urology, Keio University School of Medicine, Tokyo, Japan.ORCID 0000-0002-4371-4594
Walter M StadlerDepartment of Medical Oncology, The University of Chicago Medicine, Chicago, Illinois.ORCID 0000-0002-0435-2527
Lisa HorvathDepartment of Medical Oncology, Chris O'Brien Lifehouse, Camperdown, Australia.ORCID 0000-0001-6842-9223
Richard GreilIIIrd Medical Department, Paracelsus Medical University Salzburg, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials (SCRI-CCCIT), Cancer Cluster Salzburg, Salzburg, Austria.ORCID 0000-0002-4462-3694
Bert O'NeilCancer Research Program, Community Health Network, Indianapolis, Indiana.ORCID 0000-0001-7032-7453
Bilal A SiddiquiDepartment of Genitourinary Medical Oncology, Division of Cancer Medicine, MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0002-6806-1294
Thomas BauernhoferDivision of Clinical Oncology, Medical University of Graz, Graz, Austria.ORCID 0000-0001-9124-4876
Mehmet A BilenWinship Cancer Institute of Emory University, Atlanta, Georgia.ORCID 0000-0003-4003-1103
Ferry EskensDepartment of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.ORCID 0009-0000-3870-5100
Shahneen SandhuMelanoma and Uro-oncology Unit, Peter MacCallum Cancer Centre and the University of Melbourne, Melbourne, Australia.ORCID 0000-0002-8660-4475
Crystal ShawAmgen Inc., Thousand Oaks, California.ORCID 0000-0001-6349-072X
Chia Hsin JuAmgen Inc., Thousand Oaks, California.ORCID 0009-0009-2340-2006
Benjamin E DecatoAmgen Inc., Thousand Oaks, California.ORCID 0000-0003-3092-1102
Brian YuAmgen Inc., Thousand Oaks, California.ORCID 0000-0002-3051-1624
Ana AparicioDepartment of Genitourinary Medical Oncology, University of Texas, MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0003-0900-0923

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeNeuroendocrine prostate cancer (NEPC) is an aggressive form of prostate cancer with poor prognosis and limited treatment options. As NEPC aberrantly expresses delta-like ligand 3 (DLL3), the activity of tarlatamab, a bispecific T-cell engager that directs cytotoxic T cells to DLL3-positive (DLL3+) cells, was evaluated in the DeLLpro-300 study (NCT04702737). PATIENTS AND

methodsThis was a phase 1b, open-label study evaluating tarlatamab monotherapy in patients with metastatic de novo or treatment-emergent NEPC defined by histologic, genomic, or IHC criteria. Tarlatamab was administered intravenously every 2 weeks at a dose of 100 mg with a 1-mg step dose. The primary objective was safety, and a secondary objective was objective response rate (ORR) per RECIST v.1.1; DLL3 expression was retrospectively assessed by IHC.

resultsForty patients were enrolled (DLL3+ tumors, n = 18; DLL3- tumors, n = 14; and DLL3 unknown tumors, n = 8). The most common treatment-related adverse events were cytokine release syndrome (82.5%), dysgeusia (42.5%), and decreased appetite (40.0%). Cytokine release syndrome was predominantly of low grade (grade 1/2/3/4+, 62.5%/15%/5%/0%), occurred exclusively in cycle 1, and was transient in duration (median duration, 3 days). The ORR was 10.5% [95% confidence interval (CI), 2.9-24.8]; the median duration of response was 7.3 months in the overall cohort. Patients with DLL3+ tumors (vs. patients with DLL3-/DLL3 unknown tumors) achieved a higher ORR [22.2% (95% CI, 6.4-47.6) vs. 0% (95% CI, 0-15.4)] and radiographic progression-free survival rate at 6 months [27.7% (95% CI, 8.7-50.9) vs. 0%].

conclusionsThe DeLLpro-300 study provides preliminary evidence for the safety and antitumor activity of tarlatamab in DLL3+ NEPC.

Indexed as

Carcinoma, NeuroendocrineNeuroendocrine TumorsProstatic NeoplasmsAgedAged, 80 and overHumansIntracellular Signaling Peptides and ProteinsMaleMembrane ProteinsMiddle AgedTreatment OutcomeDLL3 protein, humanIntracellular Signaling Peptides and ProteinsMembrane Proteins

Identifiers

PMID40689871
PMCPMC12434391

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.