JNJ-2421 / J&J - LARVOL DELTA

JNJ-79032421, a Novel Membrane-restricted Mesothelin-targeting T-cell-engaging Bispecific Antibody for the Treatment of Mesothelin-positive Cancers. (PubMed, Mol Cancer Ther) - "Increases of CD45+ and CD8+ T-cell infiltrates, as well as CD8+ T-cell activation, observed in xenograft tumor tissues were time and JNJ-79032421 dose dependent. Overall, these data suggest that JNJ-79032421 may offer meaningful clinical activity by avoiding binding to sMSLN."

Journal • Mesothelioma • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor • CD8 • MSLN • PTPRC

A Study of JNJ-79032421 Targeting Mesothelin for Advanced Stage Solid Tumors (clinicaltrials.gov) - P1 | N=35 | Completed | Sponsor: Janssen Research & Development, LLC | Active, not recruiting ➔ Completed | Trial completion date: Sep 2025 ➔ Jun 2025 | Trial primary completion date: Sep 2025 ➔ Jun 2025

Trial completion • Trial completion date • Trial primary completion date • Solid Tumor

A Study of JNJ-79032421 Targeting Mesothelin for Advanced Stage Solid Tumors (clinicaltrials.gov) - P1 | N=36 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Mar 2028 ➔ Sep 2025 | Trial primary completion date: Feb 2026 ➔ Sep 2025

Trial completion date • Trial primary completion date • Solid Tumor

ZW171, a differentiated 2+1 T cell-engaging bispecific antibody with antitumor activity in a range of mesothelin-expressing cancers (AACR 2025) - P1 | "We previously showed that the unique geometry and 2+1 design of ZW171 facilitates tumor selective binding and potent preferential killing of MSLN-mid and -high target cells, while sparing MSLN-low expressing target cells, and enhanced antitumor activity compared to other 2+1 TCE formats and the clinical benchmark HPN536 in MSLN-expressing PBMC-engrafted CDX models. To address the evolving clinical landscape and assess antitumor activity in additional indications and more translationally relevant models, we assessed ZW171 activity in advanced patient-derived organoid and xenograft models and benchmarked to other MSLN-targeting TCE including AMG 305, JNJ-79032421 and CT95...Overall, ZW171 demonstrates differentiated and potent antitumor activity in a range of MSLN-expressing cancers. ZW171 is being evaluated in a Phase 1 clinical trial in MSLN-expressing solid tumors (NCT06523803)."

Gastric Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor • MSLN

A Study of JNJ-79032421 Targeting Mesothelin for Advanced Stage Solid Tumors (clinicaltrials.gov) - P1 | N=36 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Recruiting ➔ Active, not recruiting | N=210 ➔ 36 | Trial primary completion date: Feb 2027 ➔ Feb 2026

Enrollment change • Enrollment closed • Trial primary completion date • Solid Tumor

A Study of JNJ-79032421 Targeting Mesothelin for Advanced Stage Solid Tumors (clinicaltrials.gov) - P1 | N=210 | Recruiting | Sponsor: Janssen Research & Development, LLC | N=120 ➔ 210 | Trial completion date: Feb 2027 ➔ Feb 2028

Enrollment change • Trial completion date • Oncology • Solid Tumor

JNJ-79032421 is a novel membrane restricted mesothelin targeting T-cell engaging bispecific antibody for treatment of mesothelin-positive cancers (EORTC-NCI-AACR 2024) - P1 | "Thus, JNJ-79032421, is a highly differentiated BsAb whose safety and efficacy are currently being investigated in a Phase I study."

Gastrointestinal Cancer • Mesothelioma • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor • CASP7 • MSLN

A Study of JNJ-79032421 Targeting Mesothelin for Advanced Stage Solid Tumors (clinicaltrials.gov) - P1 | N=120 | Recruiting | Sponsor: Janssen Research & Development, LLC

Metastases • New P1 trial • Oncology • Solid Tumor