Evidence map›Paper›PMID 41493473›Full record

ArticleCancer chemotherapy and pharmacology2026

A phase 1, first-in-human, dose escalation study of JNJ-80038114, a PSMAxCD3 bispecific antibody, in participants with metastatic castration-resistant prostate cancer.

Andrew Hudson, Anuradha Jayaram, Benjamin Garmezy, Nicholas A Zorko, Kevin K Zarrabi, Ligi Mathews, Brent Rupnow, Mengjie Li, Debopriya Ghosh, Karen Urtishak and 4 more

Registry-linked trialAbstract readClinical Trial, Phase IMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Cancer chemotherapy and pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05441501 (A Phase 1 Study of JNJ-80038114, a T-Cell Redirecting Agent Targeting Prostate Specific Membrane Antigen), which is not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
–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.

NCT05441501 phase1completednot on this map

A Phase 1 Study of JNJ-80038114, a T-Cell Redirecting Agent Targeting Prostate Specific Membrane Antigen (PSMA), for Advanced Stage Prostate Cancer

TypeinterventionalSponsorJanssen Research & Development, LLCRan2022 to 2024Enrolled39ConditionsProstatic NeoplasmsArmsJNJ-80038114
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
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

14 authors.

Andrew HudsonThe Christie NHS Foundation Trust, Manchester, UK.
Anuradha JayaramUCLH Foundation Trust, London, UK.
Benjamin GarmezySarah Cannon Research Institute, Nashville, TN, USA.
Nicholas A ZorkoUniversity of Minnesota Masonic Cancer Center, Minneapolis, MN, USA.
Kevin K ZarrabiThomas Jefferson University Hospital, Philadelphia, PA, USA.
Ligi MathewsJohnson & Johnson, 851 Duportail Road, Chesterbrook, PA, 19087, USA.
Brent RupnowJohnson & Johnson, Spring House, PA, USA.
Mengjie LiJohnson & Johnson, Spring House, PA, USA.
Debopriya GhoshJohnson & Johnson, Spring House, PA, USA.
Karen UrtishakJohnson & Johnson, Spring House, PA, USA.
Peter FrancisJohnson & Johnson, Raritan, NJ, USA.
Sherry C WangJohnson & Johnson, Spring House, PA, USA.
Edward AttiyehJohnson & Johnson, 851 Duportail Road, Chesterbrook, PA, 19087, USA. eattiyeh@its.jnj.com.
Johann de BonoRoyal Marsden NHS Foundation Trust, Surrey, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeProstate-specific membrane antigen (PSMA) has been identified as a therapeutic target for metastatic castration-resistant prostate cancer (mCRPC). The recent success of radioligands targeting PSMA spurred development of new PSMA-targeting agents including immunotherapy. JNJ-80038114 is a bispecific antibody that binds PSMA on tumor cells and CD3 on T cells to induce anti-tumor activity.

methodsThis was a phase 1, open-label, multicenter study of JNJ-80038114 in participants with mCRPC and ≥ 1 prior systemic therapy. JNJ-80038114 was administered subcutaneously every 3 weeks (Q3W), starting at 0.1 mg. The primary endpoint was safety. Secondary endpoints included pharmacokinetics (PK), immunogenicity, and prostate-specific antigen (PSA).

resultsAt final analysis, 39 participants received 0.1-180 mg JNJ-80038114 across 11 dose-escalation cohorts for a median of 9.3 weeks (range, 0.1-31.1). The most common treatment-related adverse events (TRAEs; ≥20%) included cytokine release syndrome (CRS, 51.3%, all Grade 1-2), injection-site reactions (46.2%), and fatigue (30.8%). Related Grade ≥ 3 TRAEs occurred in 51.3% of participants; dose-limiting toxicities occurred in 3 (7.7%). Four participants (10.3%) developed clinically significant neuropathies. In 37 PK-evaluable participants, mean exposure (C

conclusionsThis first-in-human study of JNJ-80038114 was discontinued early due to its lack of preliminary clinical activity, neurologic toxicities, high rates of CRS, and the development of ADAs impacting PK. CLINICALTRIAL: GOV INFORMATION: NCT05441501, Registered July 1, 2022.

Indexed as

Antibodies, BispecificGlutamate Carboxypeptidase IIProstatic Neoplasms, Castration-ResistantAgedAged, 80 and overAntigens, SurfaceCD3 ComplexDose-Response Relationship, DrugHumansMaleMiddle AgedProstate-Specific AntigenAntibodies, BispecificAntigens, SurfaceCD3 ComplexFOLH1 protein, humanGlutamate Carboxypeptidase IIProstate-Specific AntigenBispecific antibodyFirst-in-humanJNJ-80038114Metastatic castration-resistant prostate cancerPSMA

Identifiers

PMID41493473
PMCPMC12774958

What Socratic holds

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LicenceCC BY
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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 Socratic graph.