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New treatment option for Advanced Relapsed or Refractory Germ Cell Tumours
Official title A Study to Test How Well Different Doses of BI 3820768 Are Tolerated by People With Advanced Cancer (Solid Tumours)
ClinicalTrials.gov ID: NCT07306559
What this study is testing
What is BI 3820768?
BI 3820768 is an investigational medicine, given as an once-weekly injectable medicine, being studied as a potential treatment for advanced relapsed or refractory germ cell 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 open to adults with advanced germ cell tumours, endometrial cancer, or ovarian cancer whose previous treatments were not successful. People can join the study if they have no remaining treatment options or if standard therapy is not suitable.
- Phase 1: an early, usually small safety study
- Time commitment: about 3 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
- Patient must be ≥18 years of age and at least at the legal age of consent in countries where it is older than 18 years at the time of signature on...
- For patients with endometrial cancer (EC) and ovarian cancer (OVC), signed and dated written ICF1 for target testing.
- Signed and dated ICF2 for all patients describing the study in accordance with International Council on Harmonisation Good Clinical Practice...
- Prior to Screening Visit 02, confirmed target-positivity for EC and OVC based on central laboratory testing of tumour tissue sample.
- Patients with a histologically or cytologically confirmed diagnosis of germ cell tumour (GCT), EC, or OVC.
You likely can't join if
- Patient with a history of a major surgery within 28 days prior to the first dose of BI 3820768 (major according to the Investigator's and/or...
- Previous or concomitant malignancies other than the one treated in this trial within the past 3 years except:
- Effectively treated non-melanoma skin cancers
- Effectively treated carcinoma in situ of the cervix
- Effectively treated ductal carcinoma in situ
- Other effectively treated malignancy that is considered cured by local treatment
See the full eligibility criteria
- Patient must be ≥18 years of age and at least at the legal age of consent in countries where it is older than 18 years at the time of signature on the informed consent forms (ICFs).
- For patients with endometrial cancer (EC) and ovarian cancer (OVC), signed and dated written ICF1 for target testing.
- Signed and dated ICF2 for all patients describing the study in accordance with International Council on Harmonisation Good Clinical Practice (ICH-GCP) and local legislation prior to any trial-specific procedures...
- Prior to Screening Visit 02, confirmed target-positivity for EC and OVC based on central laboratory testing of tumour tissue sample.
- Patients with a histologically or cytologically confirmed diagnosis of germ cell tumour (GCT), EC, or OVC.
- Patients with advanced, relapsed/refractory (r/r) GCT, EC, or OVC.
- Patients with disease progression despite conventional treatment, intolerant to or not a candidate for conventional treatment, who have exhausted all established treatment options.
- Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Further apply.
- Patient with a history of a major surgery within 28 days prior to the first dose of BI 3820768 (major according to the Investigator's and/or Sponsor's assessment).
- Previous or concomitant malignancies other than the one treated in this trial within the past 3 years except:
- Effectively treated non-melanoma skin cancers
- Effectively treated carcinoma in situ of the cervix
- Effectively treated ductal carcinoma in situ
- Other effectively treated malignancy that is considered cured by local treatment
- Patient with known leptomeningeal disease or spinal cord compression due to disease.
- Presence of any infection requiring systemic antimicrobial treatment within 7 days prior to the first dose of trial medication. Patients who have any clinical signs of infection (e.g. fever or leukocytosis) within 48 h...
- Patients with Hepatitis-C-Virus (HCV) infection, defined as:
- Currently receiving curative antiviral treatment for HCV infection, and/or
- HCV viral load is above the limit of quantification (HCV RNA positive).
- Patients with active hepatitis B virus (HBV) infection (chronic or acute); defined as having a positive hepatitis B surface antigen (HBsAg), and HBsAg test at screening.
- Patient with past HBV infection or resolved HBV infection (defined as the presence of hepatitis B core antibody (HBcAb) and absence of HbsAg) are eligible. HBV DNA must be obtained in these patients prior study start...
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Indianapolis, Indiana, United States
- Houston, Texas, United States
- Brussels, Belgium
- Leuven, Belgium
- Marseille, France
- Villejuif, France
- München, Germany
- Würzburg, Germany
- Chiba, Kashiwa, Japan
- Tokyo, Koto-ku, Japan
- Barcelona, Spain
- Madrid, Spain
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 3 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 Los Angeles, California, United States; Indianapolis, Indiana, United States; Houston, Texas, United States; Brussels, Belgium; Leuven, Belgium; Marseille, France and 7 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.