Bemcentinib

DRUG11 trials

Sponsors

Oslo University Hospital Hf, Oslo University Hospital Hf, BerGenBio ASA, University of Texas Southwestern Medical Center, GWT-TUD GmbH, The University of Texas Health Science Center at San Antonio

Conditions

Acute Myeloid LeukemiaAdenocarcinoma of LungAdvanced Lung AdenocarcinomaCOVID-19Cancer of PancreasCarcinoma, Non-Small-Cell LungGlioblastomaHead & Neck Cancer

Phase 1

A Study of BGB324 (Bemcentinib) in Combination With Erlotinib in Patients With Non-Small Cell Lung Cancer

CompletedNCT02424617

BerGenBio ASANon-Small Cell Lung Cancer

Start: 2015-04-19End: 2021-08-25Updated: 2025-02-26

A Phase Ib/II Multicenter Open-label Study of Bemcentinib (BGB324) in Patients With AML or MDS

CompletedNCT02488408

BerGenBio ASAAcute Myeloid Leukemia, Myelodysplastic Syndromes

Start: 2014-10-22End: 2022-06-08Updated: 2024-12-19

Clinical Trial of Chemotherapy and Bemcentinib for Metastatic Pancreatic Cancer

TerminatedNCT03649321

University of Texas Southwestern Medical CenterCancer of Pancreas

Start: 2019-01-03End: 2022-06-27Updated: 2023-11-09

A Clinical Study of Bemcentinib With Standard of Care Chemoimmunotherapy in Untreated Advanced/Metastatic Non-small Cell Lung Cancer Patients With a Mutation in the STK11 Gene

TerminatedNCT05469178

BerGenBio ASACarcinoma, Non-Small-Cell Lung

Start: 2023-03-03End: 2025-04-03Updated: 2025-10-29

A Study to Investigate 14C-bemcentinib in Healthy Male Subjects

CompletedNCT06469138

BerGenBio ASAAcute Myeloid Leukemia, COVID-19, Glioblastoma +5

Start: 2022-08-02End: 2022-09-23Updated: 2025-01-29

Study of Bemcentinib Plus Pacritinib In Patients With Advanced Lung Adenocarcinoma

TerminatedNCT06516887

The University of Texas Health Science Center at San AntonioAdvanced Lung Adenocarcinoma

Start: 2024-12-27End: 2026-05-21Updated: 2026-05-26

Phase 2

Bemcentinib (BGB324) in Combination With Pembrolizumab in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)

CompletedNCT03184571

BerGenBio ASAAdenocarcinoma of Lung, Lung Cancer Metastatic, NSCLC Stage IV

Start: 2017-10-02End: 2022-10-27Updated: 2025-09-25

Evaluating the Efficacy and Safety of Bemcentinib in Patients With Myelodysplastic Syndromes

CompletedNCT03824080

GWT-TUD GmbHAcute Myeloid Leukemia, High-risk Myelodysplastic Syndrome, Low-risk Myelodysplastic Syndrome

Start: 2018-12-20End: 2021-06-08Updated: 2021-12-21

A Study of Bemcentinib for the Treatment of COVID-19 in Hospitalised Patients

CompletedNCT04890509

BerGenBio ASACOVID-19

Start: 2020-10-20End: 2021-05-25Updated: 2024-10-16

Efficacy and Safety of AXL-Inhibitor bemcentinib for the Treatment of Moderate COVID-19 (AXL-SolidAct)

CompletedCTIS2022-500363-12-00

Oslo University Hospital Hf, Oslo University Hospital HfSARS CoV-2 (COVID-19)

Start: 2022-08-24End: 2023-12-08Target: 400Updated: 2023-07-04

Phase 3

Postoperative Radiotherapy Combined With Nimotuzumab Followed by Benmelstobart in High-Risk Patients With Head and Neck Squamous Cell Carcinoma

RecruitingNCT07445048

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityHead & Neck Cancer, Head & Neck Squamous Cell Carcinoma, Postoperative Adjuvant Treatment

Start: 2026-03-04End: 2031-03-05Target: 370Updated: 2026-04-17

Related Papers

Abstract LB401: Bemcentinib and pembrolizumab may overcome exhaustive immune phenotypes in patients with treatment refractory lung adenocarcinoma and reveals a potential STAT3 bypass mechanism

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Bemcentinib as monotherapy and in combination with low-dose cytarabine in acute myeloid leukemia patients unfit for intensive chemotherapy: a phase 1b/2a trial.

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Experiences and challenges with the new European Clinical Trials Regulation.

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AML Treatment By the AXL Inhibitor Bemcentinib in Combination with Cytarabine Shows Clinical Efficacy Related to TNFα and Cytotoxic Immune Cells: A Single-Cell Translational Study from the BGBC003 Trial

Blood2023-11-021 citations

598 Bemcentinib + pembrolizumab show promising efficacy in metastatic NSCLC harbouring mutations associated with poor prognosis: exploratory sub-analysis from the BGBC008 trial (NCT03184571)

Regular and Young Investigator Award Abstracts2023-10-31

Phase 1b/2a safety and tolerability study of bemcentinib (BEM) with pembrolizumab/carboplatin/pemetrexed in first line (1L) advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) without/with a STK11 mutation.

Journal of Clinical Oncology2023-06-014 citations

Abstract 3245: AXL as a therapeutic target in STK11 mutant NSCLC

Cancer Research2023-04-04

602 AXL targeting with bemcentinb restores PD-1 blockade sensitivity of STK11/LKB1 mutant NSCLC through innate immune cell mediated expansion of TCF1+ CD8 T cells

Regular and Young Investigator Award Abstracts2021-11-011 citations

Ph I/II study of oral selective AXL inhibitor bemcentinib (BGB324) in combination with erlotinib in patients with advanced EGFRm NSCLC: End of trial update.

Journal of Clinical Oncology2021-05-2018 citations

362 A PhII study of bemcentinib, a first-in-class selective AXL kinase inhibitor, in combination with pembrolizumab in pts with previously-treated advanced NSCLC: Updated clinical & translational analysis

Regular and Young Investigator Award Abstracts2020-11-014 citations

A phase II study of bemcentinib (BGB324), a first-in-class highly selective AXL inhibitor, with pembrolizumab in pts with advanced NSCLC: OS for stage I and preliminary stage II efficacy.

Journal of Clinical Oncology2019-05-2028 citations

First-in class selective AXL inhibitor bemcentinib (BGB324) in combination with LDAC or decitabine exerts anti-leukaemic activity in AML patients unfit for intensive chemotherapy: Phase II open-label study.

Journal of Clinical Oncology2019-05-207 citations

A randomized clinical trial of chemotherapy with gemcitabine/cisplatin/nabpaclitaxel with or without the AXL inhibitor bemcentinib (BGB324) for patients with advanced pancreatic cancer.

Journal of Clinical Oncology2019-01-2910 citations

Final Analysis of the Dose Escalation, Expansion and Biomarker Correlations in the Ph I/II Trial BGBC003 with the Selective Oral AXL Inhibitor Bemcentinib (BGB324) in Relapsed/Refractory AML and MDS

Blood2018-11-2910 citations

Predictive and pharmacodynamic biomarkers associated with phase II, selective and orally bioavailable AXL inhibitor bemcentinib across multiple clinical trials

Annals of Oncology2018-10-017 citations

Abstract 3774: BGB324, a selective small-molecule inhibitor of receptor tyrosine kinase AXL, targets tumor immune suppression and enhances immune checkpoint inhibitor efficacy

Cancer Research2018-07-014 citations

Phase II open-label, multi-centre study of bemcentinib (BGB324), a first-in-class selective AXL inhibitor, in combination with pembrolizumab in patients with advanced NSCLC.

Journal of Clinical Oncology2018-05-2010 citations

Analysis of anti-leukemic activity, predictive biomarker candidates, immune activation and pharmakodynamics in R/R AML and MDS in response to treatment with bemcentinib (BGB324), a first-in class selective AXL inhibitor, in a phase II open-label, multi-centre study.

Journal of Clinical Oncology2018-05-202 citations

Identification of predictive and pharmacodynamic biomarkers associated with the first-in-class selective axl inhibitor bemcentinib across multiple phase II clinical trials.

Journal of Clinical Oncology2018-05-201 citations

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