obertamig (JNJ-6358)
/ J&J, Zymeworks
- LARVOL DELTA
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March 10, 2025
JNJ-78306358, a first-in-class bispecific T cell engaging antibody targeting CD3 and HLA-G.
(PubMed, iScience)
- "JNJ-78306358 also blocked the interaction of HLA-G with its receptors in vitro, indicating that immune checkpoint blocking may contribute to its anti-tumor activity. These results suggest that T cell-redirection against HLA-G could be a potent and effective treatment for a wide range of solid tumor indications."
Journal • Oncology • Solid Tumor • HLA-G
August 06, 2024
Safety and clinical activity of JNJ-78306358, a human leukocyte antigen-G (HLA-G) x CD3 bispecific antibody, for the treatment of advanced stage solid tumors.
(PubMed, Cancer Immunol Immunother)
- P1 | "JNJ-78306358 showed pharmacodynamic effects with induction of cytokines and T cell activation. JNJ-78306358 was associated with CRS-related toxicities including increased transaminases and pneumonitis which limited its dose escalation to potentially efficacious levels. Trial registration number ClinicalTrials.gov (No. NCT04991740)."
Journal • Metastases • Colorectal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Oncology • Ovarian Cancer • Pneumonia • Renal Cell Carcinoma • Solid Tumor • HLA-G
July 27, 2023
Safety and preliminary clinical activity of JNJ-78306358 (JNJ-358), an HLA-G and CD3 bispecific antibody, for the treatment of advanced stage solid tumor
(ESMO 2023)
- P1 | "CRS was G1 or G2 and responded to tocilizumab. Considering the CRS-related toxicities and the ADA formation, the Sponsor decided to halt dose escalation. No recommended phase 2 dose was determined."
Clinical • Metastases • Colorectal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor • HLA-G
March 23, 2022
JNJ-78306358: A first-in-class bispecific T cell redirecting HLA-G antibody
(AACR 2022)
- P1 | "JNJ-78306358’s safety, tolerability and preliminary anti-tumor activity are currently being evaluated in a first-in-human phase I study in advanced stage solid tumors with high prevalence of HLA-G protein expression (NCT04991740). This antigen-targeting approach may address an unmet medical need in patients with tumors expressing HLA-G."
Colorectal Cancer • Endometrial Adenocarcinoma • Gastrointestinal Cancer • Genito-urinary Cancer • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Rectal Cancer • Renal Cell Carcinoma • Solid Tumor • CD34 • CD8
February 24, 2023
A Study of JNJ-78306358 in Participants With Advanced Stage Solid Tumors
(clinicaltrials.gov)
- P1 | N=39 | Completed | Sponsor: Janssen Research & Development, LLC | Active, not recruiting ➔ Completed | Trial completion date: Jan 2025 ➔ Feb 2023 | Trial primary completion date: Feb 2024 ➔ Feb 2023
Metastases • Trial completion • Trial completion date • Trial primary completion date • Colorectal Cancer • Gastrointestinal Cancer • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor • EGFR • MSI
December 02, 2022
A Study of JNJ-78306358 in Participants With Advanced Stage Solid Tumors
(clinicaltrials.gov)
- P1 | N=39 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Recruiting ➔ Active, not recruiting | N=140 ➔ 39
Enrollment change • Enrollment closed • Colorectal Cancer • Gastrointestinal Cancer • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor • EGFR • MSI
October 06, 2022
A Study of JNJ-78306358 in Participants With Advanced Stage Solid Tumors
(clinicaltrials.gov)
- P1 | N=140 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Aug 2024 ➔ Jan 2025
Trial completion date • Colorectal Cancer • Gastrointestinal Cancer • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor • EGFR • MSI
March 25, 2022
A Study of JNJ-78306358 in Participants With Advanced Stage Solid Tumors
(clinicaltrials.gov)
- P1 | N=140 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Apr 2024 ➔ Aug 2024
Trial completion date • Colorectal Cancer • Gastrointestinal Cancer • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor • EGFR • MSI
December 01, 2021
Zymeworks Announces Second Janssen Bispecific Antibody to Begin Clinical Development Utilizing Azymetric and EFECT Therapeutic Platforms
(Businesswire)
- "Zymeworks...announced that Janssen Biotech, Inc. ('Janssen') dosed the first patient with JNJ-78306358, a bispecific antibody developed using Zymeworks’ Azymetric™ and EFECT™ therapeutic platforms....Zymeworks will receive a payment in connection with this milestone under Zymeworks’ 2017 licensing agreement with Janssen."
Financing • Trial status • Oncology • Solid Tumor
November 24, 2021
A Study of JNJ-78306358 in Participants With Advanced Stage Solid Tumors
(clinicaltrials.gov)
- P1; N=140; Recruiting; Sponsor: Janssen Research & Development, LLC; Not yet recruiting ➔ Recruiting
Enrollment open • Colorectal Cancer • Gastrointestinal Cancer • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor • EGFR • MSI
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