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New treatment option for Advanced Solid Cancer
Official title A Study in People With Advanced Cancer to Test How Well Different Doses of BI 3819026 Are Tolerated When Taken Alone and Together With Ezabenlimab
ClinicalTrials.gov ID: NCT07607678
What this study is testing
What is BI 3819026?
BI 3819026 is an investigational medicine, being studied as a potential treatment for advanced solid cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is open to adults with advanced cancer. The purpose of this study is to find the highest dose of BI 3819026 that people with advanced cancer can tolerate when taken alone and together with ezabenlimab.
- Phase 1: an early, usually small safety study
- Time commitment: about 2 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants with histologically confirmed unresectable advanced or metastatic solid tumours who have documented progression after or are refractory...
- At least one measurable disease lesion outside of the central nervous system (CNS) defined per Response Evaluation Criteria in Solid Tumours (RECIST)...
- Patients with brain metastases are eligible provided they meet the following criteria:
- Brain metastases have adequately been treated and are without progression or haemorrhage and are considered stable and asymptomatic by the...
- Radiotherapy and/or surgery for brain metastases was completed at least 14 and 28 days, respectively, prior to the first administration of BI 3819026,
You likely can't join if
- Previous or concomitant malignancies other than the one treated in this trial within the last 3 years except:
- Effectively treated non-melanoma skin cancers
- Effectively treated carcinoma in situ of the cervix
- Effectively treated ductal carcinoma in situ of the breast
- Other effectively treated malignancy that is considered cured by local treatment
- Has received prior therapy with an immune-checkpoint inhibitor that was discontinued due to immune-related adverse events (AE)
See the full eligibility criteria
- Participants with histologically confirmed unresectable advanced or metastatic solid tumours who have documented progression after or are refractory to or ineligible for established and available therapies with proven...
- At least one measurable disease lesion outside of the central nervous system (CNS) defined per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1
- Patients with brain metastases are eligible provided they meet the following criteria:
- Brain metastases have adequately been treated and are without progression or haemorrhage and are considered stable and asymptomatic by the investigator,
- Radiotherapy and/or surgery for brain metastases was completed at least 14 and 28 days, respectively, prior to the first administration of BI 3819026,
- Patient is off steroids and anti-convulsive drugs for at least 7 days prior to the first administration of BI 3819026 and has no requirement for such therapy at the time of initiating trial treatment.
- Availability of archived formalin-fixed and paraffin embedded (FFPE) tumour tissue. Patients who do not have archived FFPE tumour tissue available may be allowed to enrol without archival tumour tissue upon agreement...
- All toxicities related to previous anti-cancer therapies have resolved to Grade ≤1 or baseline prior to trial treatment administration (except for alopecia, peripheral neuropathy and endocrinopathies considered...
- Adequate liver, bone marrow and renal organ function Further apply.
- Previous or concomitant malignancies other than the one treated in this trial within the last 3 years except:
- Effectively treated non-melanoma skin cancers
- Effectively treated carcinoma in situ of the cervix
- Effectively treated ductal carcinoma in situ of the breast
- Other effectively treated malignancy that is considered cured by local treatment
- Has received prior therapy with an immune-checkpoint inhibitor that was discontinued due to immune-related adverse events (AE)
- Prior treatment with systemic anti-cancer drugs (including any agents or investigational medicinal products) within 3 weeks or 5 half-lives (whichever is shorter) before the first dose of trial treatment
- Radiotherapy within 4 weeks prior to start of the trial treatment except as follows:
- Palliative radiotherapy to regions other than the chest is allowed if completed at least 2 weeks prior and is not on the target lesion (which should be outside of the radiation field)
- Single dose palliative radiotherapy for symptomatic metastasis that is not the target lesion (which should be outside of the radiation field) within 2 weeks prior may be allowed
- Active/previous history of interstitial lung disease, pulmonary fibrosis, organising pneumonia or non-infectious pneumonitis (any grade)
- Patients with active autoimmune disease or a documented history of autoimmune disease, that requires systemic treatment, e.g. corticosteroids or immunosuppressive drugs, except patients with vitiligo, resolved childhood...
- Patient has a diagnosis of immunodeficiency other than human immunodeficiency virus (HIV)
- Patients with history of HIV infection who meet one or more of the following criteria:
- CD4+ count \<350 cells/µL
- Viral load \>400 copies/mL
- Not receiving antiretroviral therapy
- Receiving established antiretroviral therapy for less than four weeks prior to the start of trial treatment
- History of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within 12 months prior to start of trial treatment Patients with a history of HIV who do not meet any of the exclusion criteria...
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
- Hackensack, New Jersey, United States
- New York, New York, United States
- Nashville, Tennessee, United States
- Chiba, Kashiwa, Japan
- Tokyo, Chuo-ku, Japan
- Barcelona, Spain
- Pamplona, Spain
- Valencia, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, United States; Hackensack, New Jersey, United States; New York, New York, United States; Nashville, Tennessee, United States; Chiba, Kashiwa, Japan; Tokyo, Chuo-ku, Japan and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.