Informations générales (source: ClinicalTrials.gov)
A Phase I Study to Determine the Safety and Tolerability of BI 3820768 in Patients With Advanced Relapsed or Refractory Germ Cell Tumours, Endometrial Cancer, or Ovarian Cancer
Interventional
Phase 1
Boehringer Ingelheim (Voir sur ClinicalTrials)
février 2026
décembre 2029
23 juillet 2026
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. The
purpose of this study is to test increasing doses of BI 3820768 to find a dose that
people with these types of cancer can tolerate and that may make tumours shrink. BI
3820768 is a type of treatment that may help the immune system fight cancer. This is the
first time BI 3820768 is being tested in humans.
The study has 2 parts based on the way BI 3820768 is given. Depending on when
participants join the study, they will receive BI 3820768 through one of two ways to
inject the study medicine. All participants receive the study medicine. The medicine is
given as an injection once a week for 2 cycles of 3 weeks each, followed by doses every 3
weeks.
Participants are in the study for up to 3 years if they are benefiting from the
treatment. During this time, they visit the study site regularly, and some visits will
require overnight stays. Doctors will regularly check the size of the tumour and whether
it has spread. Researchers want to find the highest dose of BI 3820768 that participants
can tolerate by looking at the number of participants with certain severe health
problems. The doctors also regularly check participants' health, take blood samples, and
note any unwanted effects.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Kaissa OUALI | 13/07/2026 09:15:06 | Contacter | ||
Critères
Tous
Inclusion criteria :
1. 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).
2. For patients with endometrial cancer (EC) and ovarian cancer (OVC), signed and dated
written ICF1 for target testing.
3. 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, sampling, or analyses.
4. Prior to Screening Visit 02, confirmed target-positivity for EC and OVC based on
central laboratory testing of tumour tissue sample.
5. Patients with a histologically or cytologically confirmed diagnosis of germ cell
tumour (GCT), EC, or OVC.
6. Patients with advanced, relapsed/refractory (r/r) GCT, EC, or OVC.
7. Patients with disease progression despite conventional treatment, intolerant to or
not a candidate for conventional treatment, who have exhausted all established
treatment options.
8. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0
or 1.
Further inclusion criteria apply.
Exclusion criteria:
1. 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).
2. Previous or concomitant malignancies other than the one treated in this trial within
the past 3 years except:
1. Effectively treated non-melanoma skin cancers
2. Effectively treated carcinoma in situ of the cervix
3. Effectively treated ductal carcinoma in situ
4. Other effectively treated malignancy that is considered cured by local
treatment
3. Patient with known leptomeningeal disease or spinal cord compression due to disease.
4. 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 prior to the first dose of trial
medication are not eligible.
5. Patients with Hepatitis-C-Virus (HCV) infection, defined as:
1. Currently receiving curative antiviral treatment for HCV infection, and/or
2. HCV viral load is above the limit of quantification (HCV RNA positive).
6. 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.
7. 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.
Further exclusion criteria apply.
1. 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).
2. For patients with endometrial cancer (EC) and ovarian cancer (OVC), signed and dated
written ICF1 for target testing.
3. 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, sampling, or analyses.
4. Prior to Screening Visit 02, confirmed target-positivity for EC and OVC based on
central laboratory testing of tumour tissue sample.
5. Patients with a histologically or cytologically confirmed diagnosis of germ cell
tumour (GCT), EC, or OVC.
6. Patients with advanced, relapsed/refractory (r/r) GCT, EC, or OVC.
7. Patients with disease progression despite conventional treatment, intolerant to or
not a candidate for conventional treatment, who have exhausted all established
treatment options.
8. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0
or 1.
Further inclusion criteria apply.
Exclusion criteria:
1. 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).
2. Previous or concomitant malignancies other than the one treated in this trial within
the past 3 years except:
1. Effectively treated non-melanoma skin cancers
2. Effectively treated carcinoma in situ of the cervix
3. Effectively treated ductal carcinoma in situ
4. Other effectively treated malignancy that is considered cured by local
treatment
3. Patient with known leptomeningeal disease or spinal cord compression due to disease.
4. 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 prior to the first dose of trial
medication are not eligible.
5. Patients with Hepatitis-C-Virus (HCV) infection, defined as:
1. Currently receiving curative antiviral treatment for HCV infection, and/or
2. HCV viral load is above the limit of quantification (HCV RNA positive).
6. 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.
7. 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.
Further exclusion criteria apply.