Experimental cancer drug BGB-3245 studied in early trial
NCT ID NCT04249843
First seen Jun 26, 2026 · Last updated Sep 01, 2026 · Updated 2 times
Summary
This early-phase study tested an experimental drug called BGB-3245 (brimarafenib) in 109 people with advanced solid tumors that had not responded to standard treatments. The drug is designed to block certain proteins that help cancer grow. The main goals were to check safety, find the right dose, and see if the drug could shrink tumors. The study was terminated early, but it gathered important safety and dosing information.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- BGB-3245 (brimarafenib), a drug taken by mouth that targets certain cancer-related proteins
- What this could lead to
- If successful, this could point toward a new treatment option for people with advanced solid tumors that have specific genetic mutations.
- What could go wrong
- This was a very early (Phase 1) trial that was terminated, so results are limited. The drug may not shrink tumors or may cause side effects, and it is unclear if it will work for most patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
109 people
The number who actually took part.
- Started
-
Feb 2020
- Finished
-
Aug 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Key Inclusion Criteria 1. Participants had histologically confirmed advanced or metastatic solid tumors and experienced disease progression during or after systemic anticancer therapies that previously demonstrated clinical benefit (improved survival) in a representative population, or were unable to receive standard therapy. In addition, participants had to meet the eligibility criteria for the corresponding phase of the study: 1. Phase 1a: Participants had a known mutation status and tumors harboring an oncogenic mutation of the BRAF gene. The mutations of primary interest were BRAF Class II mutations, Class III mutations, or BRAF fusions. In addition, participants with tumors harboring mutations of the neuroblastoma RAS viral oncogene homolog (NRAS) gene or the Kirsten rat sarcoma virus oncogene homolog (KRAS) gene were eligible for Phase 1a. For participants with KRAS mutations, tumor types of colorectal cancer (CRC) and pancreatic cancer were excluded. 2. Phase 1b: Participants had a known mutation status and met one of the following criteria according to the group in which they were enrolled: * Group 1: Participants with tumor types other than CRC that harbored BRAF V600 mutations and who had been treated and progressed on prior BRAF and/or mitogen-activated protein kinase (MEK) inhibition. * Group 2: Participants with advanced solid tumors harboring a BRAF Class II mutation or a BRAF fusion mutation. * Group 2 BRAF Fusion Expansion: Participants with advanced solid tumors harboring a BRAF fusion mutation. 2. Participants provided archival tumor tissue or agreed to a fresh tumor biopsy for mutation and biomarker analysis. Fresh tumor biopsies were strongly recommended. 3. Participants had radiologically measurable disease as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). 4. Participants had an Eastern Cooperative Oncology Group (ECOG) performance status of ≤1. 5. Participants demonstrated adequate organ function and had not received blood transfusions within 14 days prior to the first dose of study drug. Key Exclusion Criteria 1. Participants were receiving cancer therapy (chemotherapy or other systemic anticancer therapies, immunotherapy, radiation therapy, or surgery) at the time of Cycle 1 Day 1. 2. Participants who had received prior systemic anticancer treatment within the following time frames were excluded: 1. Systemic chemotherapy within 4 weeks, or 6 weeks for nitrosourea or mitomycin, prior to Cycle 1 Day 1. 2. Biologic therapy (e.g., monoclonal antibodies), continuous or intermittent small-molecule therapies, or any other investigational agents within a period of five times the half-life of the agent or ≤4 weeks (whichever was shorter) prior to Cycle 1 Day 1. 3. Participants with severe or uncontrolled systemic disease. 4. Participants with clinically significant cardiac disease within 6 months of signing the informed consent form (ICF). 5. Participants with central nervous system (CNS) metastases, leptomeningeal carcinomatosis, or untreated spinal cord compression. 6. Participants with any unstable, preexisting major medical condition, including known human immunodeficiency virus (HIV) infection, or active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. 7. Participants who received systemic anticancer therapy within 2 weeks or five half-lives before the first dose. 8. Participants who underwent a major surgical procedure or significant traumatic injury within 4 weeks prior to the first dose, or who anticipated the need for major surgery while on study. Note: Additional protocol-defined inclusion or exclusion criteria may have applied.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Advanced or metastatic solid tumor are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Blacktown Hospital
Blacktown, New South Wales, 2148, Australia
-
Cedars Sinai Medical Center
Beverly Hills, California, 90212, United States
-
MD Anderson
Houston, Texas, 77030, United States
-
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
-
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
-
One Clinical Research
Nedlands, Perth, 6009, Australia
-
Peter MacCallum Cancer Centre
Melbourne, Victoria, 2010, Australia
-
The Kinghorn Cancer Centre, St Vincent Hospital Sydney
Sydney, New South Wales, 2010, Australia
-
University of Virginia Comprehensive Cancer Centre
Charlottesville, Virginia, 22903, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- First human test of BI 4060107 aims to find safe dose for Hard-to-Treat tumors
- Can a new drug shield kidneys from chemotherapy damage?
- Mining Responders' tumors for clues to a universal cancer therapy
- Proton boost radiotherapy aims to hit large tumors harder while sparing healthy tissue
- New antibody aims to preserve immune checkpoint while fighting cancer
- Engineered immune cells target two markers on Hard-to-Treat tumors