The purpose of this study is to collect long-term safety data in participants with cancers including acute myeloid leukemia, non-Hodgkin lymphoma, myelodysplastic syndrome, chronic lymphocytic leukemia (type of cancer of the blood and bone marrow in which the bone marrow makes a large number of abnormal blood cells) and advanced solid tumors and metastatic castration-resistant prostate cancer (mCRPC).

Start Date30 Dec 2024

Sponsor / Collaborator

Janssen Research & Development LLC

NCT04397276

/ Active, not recruitingPhase 1

A Phase 1 Study of JNJ-70218902, a T Cell Redirecting Agent, in Advanced Stage Solid Tumors

The purpose of this study is to determine the recommended Phase 2 dose(s) (RP2D[s]) and maximum tolerated dose (MTD) of JNJ-70218902 in Part 1, and to determine the safety of JNJ-70218902 RP2D(s) in Part 2.

Start Date10 Jul 2020

Sponsor / Collaborator

Janssen Research & Development LLC

100 Clinical Results associated with JNJ-70218902

100 Translational Medicine associated with JNJ-70218902

100 Patents (Medical) associated with JNJ-70218902

Literatures (Medical) associated with JNJ-70218902

17 Jan 2025·The Oncologist

A first-in-human study of JNJ-70218902, a bispecific T-cell-redirecting antibody against TMEFF2 in metastatic castration-resistant prostate cancer

Article

Author: Wu, Shujian ; Peer, Avivit ; Loffredo, John ; Xie, Hong ; Tamegnon, Monelle ; Yao, David ; Calvo, Emiliano ; Xu, Weichun ; Carles, Joan ; Sarid, David ; Lin, Vincent ; Avadhani, Anjali ; Eigl, Bernhard J ; Doger, Bernard ; Hansen, Aaron R ; Jaiprasart, Pharavee

AbstractBackgroundMetastatic castration-resistant prostate cancer (mCRPC) has a poor prognosis, necessitating the investigation of novel treatments and targets. This study evaluated JNJ-70218902 (JNJ-902), a T-cell redirector targeting transmembrane protein with epidermal growth factor-like and 2 follistatin-like domains 2 (TMEFF2) and cluster of differentiation 3, in mCRPC.Patients and methodsPatients who had measurable/evaluable mCRPC after at least one novel androgen receptor–targeted therapy or chemotherapy were eligible. Participants received subcutaneous JNJ-902 0.3, 1.0, 1.5, 3.0, or 6.0 mg once weekly (QW) or 2.0, 3.0, 4.0, or 6.0 mg biweekly (Q2W). Study objectives included assessment of safety, pharmacokinetics, immunogenicity, and preliminary efficacy.ResultsEighty-two participants were enrolled to receive at least one dose of JNJ-902 (QW; n = 38; Q2W; n = 44). Median duration of treatment was 1.91 (0.0-19.4) months across dosing groups. All participants experienced at least one treatment-emergent adverse event (TEAE) and 76 (92.7%) experienced treatment-related TEAEs. Fourteen participants (17.1%) experienced a TEAE that led to study discontinuation, of which 3 (3.7%) were related to JNJ-902. Dose-limiting toxicities were observed in 2 participants (2.4%). Five participants (15.2%) with measurable disease had a confirmed partial response and 10 participants (12.2%) had ≥50% decrease from baseline prostate-specific antigen levels. Clinical activity was not dose related and no clear exposure-response relationship was observed.ConclusionsIn this study, dose escalation was limited by emerging dose-limiting toxicities. Although a recommended phase II dose was not determined, findings indicate TMEFF2 to be a potential target in mCRPC that warrants further investigation.

100 Deals associated with JNJ-70218902

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Acute Myeloid Leukemia	Phase 1	Georgia	Janssen Research & Development LLC	30 Dec 2024
Acute Myeloid Leukemia	Phase 1	Ukraine	Janssen Research & Development LLC	30 Dec 2024
Acute Myeloid Leukemia	Phase 1	Greece	Janssen Research & Development LLC	30 Dec 2024
Acute Myeloid Leukemia	Phase 1	Belgium	Janssen Research & Development LLC	30 Dec 2024
Acute Myeloid Leukemia	Phase 1	France	Janssen Research & Development LLC	30 Dec 2024
Acute Myeloid Leukemia	Phase 1	Japan	Janssen Research & Development LLC	30 Dec 2024
Acute Myeloid Leukemia	Phase 1	United Kingdom	Janssen Research & Development LLC	30 Dec 2024
Advanced Malignant Solid Neoplasm	Phase 1	Canada	Janssen Research & Development LLC	10 Jul 2020
Advanced Malignant Solid Neoplasm	Phase 1	Israel	Janssen Research & Development LLC	10 Jul 2020
Advanced Malignant Solid Neoplasm	Phase 1	Spain	Janssen Research & Development LLC	10 Jul 2020

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04397276 (ESMO2022) Manual	Phase 1	Prostatic Cancer	73	JNJ-70218902	(gidinffaui) = nvllfpzrnk rjvtahxadw (qfgettupgu ) View more	Positive	10 Sep 2022

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