Solid Tumours study: BI
Official title A Study of BI 3810944 in Patients With Advanced Cancer
ClinicalTrials.gov ID: NCT07224425
What this study is testing
What is BI 3810944?
an investigational drug being studied as a potential treatment for advanced solid tumours
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 testing whether BI 3810944 can be safely given to people with advanced cancer and which dose works best. It also looks at how well the drug may help shrink tumours.
- Who it's for
- You may be able to join if you are an adult with advanced solid tumours or melanoma and previous treatments have not worked or are not available.
- What's involved
- You will receive BI 3810944 once every three weeks, after a short period of weekly doses. You will visit the study site regularly, including overnight stays at the start, for health checks, blood tests, and tumour scans. Doctors will record any side effects you experience.
- Time commitment
- The study lasts up to two years, with regular visits and hospital stays at the beginning.
- Phase 1: an early, usually small safety study
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
- Part A only: participants with any histologically or cytologically confirmed diagnosis of solid tumour who failed conventional treatment or for whom...
- Part B only: participants with histologically or cytologically confirmed diagnosis of who has progressed on, or is intolerant to available standard...
- Eastern cooperative oncology group (ECOG) performance status of 0 or 1
- Presence of at least one measurable lesion outside of central nervous system (CNS) as defined per response evaluation criteria in solid tumours...
- Age ≥18 years
You likely can't join if
- Active primary central nervous system (CNS) malignancy, active untreated CNS metastases and/or carcinomatous meningitis
- Radiotherapy or surgery for brain metastases was completed ≥2 weeks before the first administration of BI 3810944
- Patient is off steroids for ≥7 days (physiologic doses of steroids are permitted), and the patient is off anti-epileptic drugs for ≥7 days or on...
- A diagnosis of immunodeficiency; receiving chronic systemic therapy exceeding prednisone 10 mg daily or equivalent or any other form of...
- Participants who have been treated with any other anticancer drug(s), within 28 days or within 5 half-life periods (whichever is shorter) prior to...
- Participants who have been treated with extensive field radiotherapy including whole brain irradiation, within 2 weeks prior to first administration...
See the full eligibility criteria
- Part A only: participants with any histologically or cytologically confirmed diagnosis of solid tumour who failed conventional treatment or for whom no therapy of proven how well it works exists or who is not eligible...
- Part B only: participants with histologically or cytologically confirmed diagnosis of who has progressed on, or is intolerant to available standard therapies, or for whom no standard therapy with proven benefit exists...
- Eastern cooperative oncology group (ECOG) performance status of 0 or 1
- Presence of at least one measurable lesion outside of central nervous system (CNS) as defined per response evaluation criteria in solid tumours (RECIST v 1.1)
- Age ≥18 years
- Adequate organ function
- Life expectancy of ≥3 months at the start of the trial treatment in the opinion of the investigator
- All toxicities related to previous anticancer therapies have resolved to common terminology criteria for adverse events (CTCAE) Grade ≤1 prior to trial treatment administration (except for alopecia and peripheral...
- Active primary central nervous system (CNS) malignancy, active untreated CNS metastases and/or carcinomatous meningitis
- Radiotherapy or surgery for brain metastases was completed ≥2 weeks before the first administration of BI 3810944
- Patient is off steroids for ≥7 days (physiologic doses of steroids are permitted), and the patient is off anti-epileptic drugs for ≥7 days or on stable doses of anti-epileptic drugs for malignant CNS disease
- A diagnosis of immunodeficiency; receiving chronic systemic therapy exceeding prednisone 10 mg daily or equivalent or any other form of immunosuppressive therapy within 7 days before the step-up dose of BI 3810944
- Participants who have been treated with any other anticancer drug(s), within 28 days or within 5 half-life periods (whichever is shorter) prior to the first administration of BI 3810944
- Participants who have been treated with extensive field radiotherapy including whole brain irradiation, within 2 weeks prior to first administration of BI 3810944
- Prior treatment with organ transplant or allogenic hematopoietic stem-cell transplant
- Anticoagulant treatment that cannot be safely interrupted based on opinion of the investigator if medically needed (e.g. biopsy)
- Women who are pregnant, breastfeeding or who plan to become pregnant or breastfeeding during the trial or within 4 months after the last dose of BI 3810944 Further exclusion criteria apply.
The study team makes the final eligibility decision.
Where it is enrolling
- Louisville, Kentucky, United States
- Nashville, Tennessee, United States
- Brussels, Belgium
- Leuven, Belgium
- Nijmegen, Netherlands
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, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to 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?
This study is enrolling now at Louisville, Kentucky, United States; Nashville, Tennessee, United States; Brussels, Belgium; Leuven, Belgium; Nijmegen, Netherlands. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.