Clinical trials: NRG1 Fusion
Advanced Solid Tumor, Adult, ERBB2 Altered Breast Cancer
A Study of a Selective ERBB2 Inhibitor (CGT4255), in Patients With Advanced Solid Tumors
This is an open-label, phase 1/1b study evaluating the safety, tolerability, pharmacokinetic (what the body does to the drug), pharmacodynamic (what the drug does to the body), and antitumor activity of CGT4255 in adult…
- Conditions
- Advanced Solid Tumor, Adult, ERBB2 Altered Breast Cancer, ERBB2 Gene Amplification, HER2 Overexpression
- Trial name
- NCT07361562
- Testing
- CGT4255
- Where
- 15 sites in United States
- Volunteers
- 100 people
- Sponsor
- Cogent Biosciences, Inc.
NSCLC Harboring NRG1 Fusion, Metastatic Castration-resistant Prostate Cancer
Study Evaluating Zenocutuzumab in Patients With or Without Molecularly Defined Cancers
This is a Phase II, open-label, 2-arm, multicenter, international study designed to evaluate the efficacy of zenocutuzumab alone or in combination in patients with the following diagnoses: Group A: NRG1+ NSCLC Group B: mCRPC
- Trial name
- NCT05588609
- Testing
- Afatinib Oral Tablet, Enzalutamide Pill, Abiraterone acetate tablets
- Where
- 7 sites in United States
- Volunteers
- 13 people
- Sponsor
- Partner Therapeutics, Inc.
NRG1 Fusion, Pancreatic Cancer
Early Access Program Providing HER2/HER3 Bispecific Antibody, MCLA-128, for a Patient With Advanced NRG1-Fusion Positive Solid Tumor
Merus is providing single patient/named access to the HER2/HER3 bispecific antibody, MCLA-128, to patients with advanced NRG1-fusion positive solid tumor under this early access program who are ineligible for an ongoing MCLA-128…
- Conditions
- NRG1 Fusion, Pancreatic Cancer, Non Small Cell Lung Cancer, Solid Tumor, Unspecified, Adult
- Trial name
- NCT04100694
- Testing
- MCLA-128
- Sponsor
- Merus B.V.
Solid Tumors
Afatinib (GILOTRIF®) in Patients Suffering From Tumors Harboring Neuregulin 1 (NRG1) Gene Alterations (Specifically NRG1 Gene Fusion-positive Advanced Solid Tumors)
Gene fusions are defined as two separate genes joined together (gene 1, gene 2), generating a novel fusion gene. NRG1 fusions are rare and complex with regard to the fusion/fusion partner.
- Trial name
- NCT05107193
- Testing
- afatinib
- Sponsor
- Boehringer Ingelheim
Non-Small Cell Lung Cancer, Pancreatic Cancer
Study of an Anti-HER3 Antibody, HMBD-001, With or Without Chemotherapy in Patients With Solid Tumors Harboring an NRG1 Fusion or HER3 Mutation
This is a phase 1b multi-center, open-label study of HMBD-001 with or without chemotherapy in participants with advanced solid tumors harboring NRG1 gene fusions or selected HER3 mutations.
- Conditions
- Non-Small Cell Lung Cancer, Pancreatic Cancer, Locally Advanced Solid Tumor, Metastatic Solid Tumor
- Trial name
- NCT05919537
- Testing
- HMBD-001, Docetaxel, Nab-paclitaxel
- Where
- 5 sites in Australia
- Volunteers
- 68 people
- Sponsor
- Hummingbird Bioscience
Non-squamous, Non-Small Cell Lung Cancer
Real-World Effectiveness of Afatinib (Gilotrif) Following Immunotherapy in the Treatment of Metastatic, Squamous Cell Carcinoma of the Lung: A Multi-Site Retrospective Chart Review Study in the U.S.
Characteristics of patients with Neuregulin-1 (NRG1) gene fusion-positive solid tumors treated with afatinib, and characteristics of those treated with another systemic therapy.
- Trial name
- NCT04750824
- Testing
- Afatinib, other systemic therapy
- Where
- United States
- Volunteers
- 110 people
- Sponsor
- Boehringer Ingelheim
Metastatic Pancreatic Cancer
Single Patient Protocol for an NRG1 Fusion Positive Metastatic Pancreatic Cancer Patient Using Seribantumab
NRG1 gene fusions are extremely rare across solid tumours (estimate 0.3-0.5%). However, it is felt to be an actionable and potentially major growth pathway for those tumours that harbour this gene rearrangement.
- Trial name
- NCT04790695
- Testing
- Seribantumab
- Where
- Canada
- Volunteers
- 1 people
- Sponsor
- Ottawa Hospital Research Institute
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors
This study is an open-label, international, multi-center, Phase 2 study in adult patients with recurrent, locally-advanced or metastatic solid tumors, which harbor the NRG1 gene fusion.
- Conditions
- Locally Advanced Solid Tumor, Metastatic Solid Tumor, Pancreatic Cancer, Lung Cancer
- Trial name
- NCT04383210
- Testing
- Seribantumab
- Where
- 42 sites in United States, Australia and 2 more
- Volunteers
- 54 people
- Sponsor
- Elevation Oncology
NRG1-fused Non-small Cell Lung Cancer
To Evaluate the Efficacy of Afatinib in the Treatment of Locally Advanced/Metastatic Non-Small Cell Lung Cancer With NRG1 Fusion
This is an open-label, sing-arm, phase IV clinical study. The study is designed to evaluate the efficacy of Afatinib in treatment of NRG1-fused locally advanced/metastatic non-small cell lung cancer (NSCLC), and explore the…
- Trial name
- NCT04814056
- Testing
- Afatinib Dimaleate
- Where
- China
- Volunteers
- 15 people
- Sponsor
- Shanghai Chest Hospital
NSCLC, Stage IV, NSCLC Stage IIIB
Study of Tarloxotinib in Pts With NSCLC (EGFR Exon 20 Insertion, HER2-activating Mutations) & Other Solid Tumors With NRG1/ERBB Gene Fusions
Open-label, Phase 2, single treatment arm, 3 cohorts
- Conditions
- NSCLC, Stage IV, NSCLC Stage IIIB, NSCLC, Stage IIIC, NSCLC, Recurrent
- Trial name
- RAIN (NCT03805841)
- Testing
- tarloxotinib bromide
- Where
- 14 sites in United States, Canada and 1 more
- Volunteers
- 41 people
- Sponsor
- Rain Oncology Inc
Solid Tumours Harboring NRG1 Fusion, NSCLC Harboring NRG1 Fusion
A Study of Zenocutuzumab (MCLA-128) in Patients With Solid Tumors Harboring an NRG1 Fusion (eNRGy)
This is a Phase I/II, open-label, multi-center, multi-national, dose escalation, single agent study to assess the safety, tolerability, PK, PD, immunogenicity and anti-tumor activity of zenocutuzumab (MCLA-128) in patients with…
- Conditions
- Solid Tumours Harboring NRG1 Fusion, NSCLC Harboring NRG1 Fusion, Pancreatic Cancer Harboring NRG1 Fusion, NRG1 Fusion
- Trial name
- NCT02912949
- Testing
- zenocutuzumab (MCLA-128)
- Where
- 64 sites in United States, Austria and 16 more
- Volunteers
- 250 people
- Sponsor
- Partner Therapeutics, Inc.
Bladder Cancer, Triple Negative Breast Cancer
A Phase I/IIa Trial of HMBD-001 in Advanced HER3 Positive Solid Tumours
This clinical trial is evaluating a drug called HMBD-001 (an anti-HER3 monoclonal antibody) in participants with advanced HER3 positive solid tumours.
- Conditions
- Bladder Cancer, Triple Negative Breast Cancer, Castration-resistant Prostate Cancer, Cervical Cancer
- Trial name
- NCT05057013
- Testing
- HMBD-001, HMBD-001 and enzalutamide
- Where
- 4 sites in United Kingdom
- Volunteers
- 81 people
- Sponsor
- Cancer Research UK
Solid Tumor, Adult
Patritumab Deruxtecan in Patients With Solid Tumor Harboring an NRG1 Fusion
The NRG1 gene is located on chromosome 8 (8p12 region) and encode NRG1. NRG1 gene is translated to generate six different proteins (I-VI) and at least 31 isoforms.
- Trial name
- NCT06383884
- Testing
- Patritumab Deruxtecan
- Where
- South Korea
- Volunteers
- 30 people
- Sponsor
- Samsung Medical Center
Oncogene-addicted Non Small Cell Lung Cancer, EGFR Mutation
Integrated Genomics in Oncogene-driven NSCLC With Acquired Resistance
Currently, tyrosine kinase inhibitor (TKI) remains the standard of care for oncogene-driven non-small cell lung cancer (NSCLC). However, almost all oncogene-driven NSCLCs would develop acquired resistance against TKI in clinical…
- Conditions
- Oncogene-addicted Non Small Cell Lung Cancer, EGFR Mutation, ALK Fusion-positive Solid or CNS Tumors, ROS1 Fusion Positive
- Trial name
- NCT07122882
- Where
- Taiwan
- Volunteers
- 40 people
- Sponsor
- Chang Gung Memorial Hospital