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GEN1042

BIOLOGICAL3 trials

Sponsors

Genmab

Conditions

Colorectal Cancer (CRC)Head and Neck Squamous Cell Carcinoma (HNSCC)Malignant Solid TumorMelanomaNon-CNS TumorNon-Small Cell Lung Cancer (NSCLC)Pancreatic Ductal Adenocarcinoma (PDAC)

Phase 1

GEN1042 Safety Trial and Anti-tumor Activity in Participants With Malignant Solid Tumors
Active, not recruitingNCT04083599
GenmabColorectal Cancer (CRC), Head and Neck Squamous Cell Carcinoma (HNSCC), Malignant Solid Tumor +3
Start: 2019-09-17End: 2027-01-01Updated: 2026-08-04
A Safety and Antitumor Activity Trial of Immunoradiotherapy Combinations as a Treatment Option for Subjects With Metastatic Solid Tumors
TerminatedNCT05491317
GenmabNon-CNS Tumor
Start: 2023-03-08End: 2025-08-11Updated: 2026-08-12
A Safety Trial of GEN1042 in Japanese Subjects With Malignant Solid Tumors
Active, not recruitingNCT06057038
GenmabMalignant Solid Tumor
Start: 2023-11-24End: 2027-08-01Updated: 2026-09-10

Related Papers

Dose Selection for <scp>DuoBody</scp>®‐<scp>CD40x4</scp>‐<scp>1BB</scp> (<scp>GEN1042</scp>/<scp>BNT312</scp>) Using a <scp>mPBPK</scp>/<scp>RO</scp> Model Leveraging Preclinical and Clinical Data
Clinical Pharmacology & Therapeutics2025-05-102 citations
160TiP Safety and antitumor activity of GEN1042 in combination with pembrolizumab ± chemotherapy in solid tumors: Phase IIb dose-expansion trial in progress
Immuno-Oncology Technology2023-12-011 citations
1181 GEN1042-mIgG2a, an Fc-inert mouse-human chimeric variant of GEN1042 (DuoBody<sup>®</sup>-CD40x4–1BB), exhibits <i>in vivo</i> antitumor activity and peripheral immune modulation
Regular and Young Investigator Award Abstracts2023-10-31
Abstract 3281: GEN1042 (DuoBody-CD40x4-1BB)®in combination with PD-1 blockade reverses T-cell exhaustion <i>in vitro</i>
Cancer Research2023-04-041 citations
175P Safety and preliminary efficacy of GEN1042 (DuoBody-CD40x4-1BB) combination therapy in patients with advanced solid tumors
Immuno-Oncology Technology2022-12-013 citations
DuoBody-CD40x4-1BB induces dendritic-cell maturation and enhances T-cell activation through conditional CD40 and 4-1BB agonist activity
Journal for ImmunoTherapy of Cancer2022-06-0135 citations
493 First-in-human phase 1/2 trial to evaluate the safety and initial clinical activity of DuoBody®-CD40×4–1BB (GEN1042) in patients with advanced solid tumors
Regular and Young Investigator Award Abstracts2021-11-017 citations
Abstract 1846: DuoBody-CD40×4-1BB (GEN1042) induces dendritic-cell maturation and enhances T-cell activation and effector functions <i>in vitro</i> by conditional CD40 and 4-1BB agonist activity
Cancer Research2021-07-012 citations