Advanced Relapsed or Refractory Germ Cell TumoursPhase 1NCT07306559
A Study to Test How Well Different Doses of BI 3820768 Are Tolerated by People With Advanced Cancer (Solid Tumours)
A Phase 1 study testing BI 3820768 in people with Advanced Relapsed or Refractory Germ Cell Tumours and Advanced Relapsed or Refractory Endometrial Cancer, run by Boehringer Ingelheim at 13 sites in 6 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Relapsed or Refractory Germ Cell Tumours, Advanced Relapsed or Refractory Endometrial Cancer, Advanced Relapsed or Refractory Ovarian Cancer
- What is being tested?
- BI 3820768
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 187 participants
- Where
- 13 sitesin 6 countries
- Study dates
- 27 Feb 2026to 28 Jan 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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, sampling, or analyses.
- 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.
Show all 9Show fewer
- 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 inclusion criteria apply.
Who cannot join
- 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
Show all 14Show fewer
- 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 prior to the first dose of trial medication are not eligible.
- 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.
- Further exclusion criteria apply.
Trial locations and contacts
13 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
13 sites in 6 countries
United States3 sites, 3 recruiting
- Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
Indiana University
Indianapolis, Indiana, 46202
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Valkyrie Clinical Trials
Los Angeles, California, 90067
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Belgium2 sites, 1 recruiting
- Recruiting
Cliniques Universitaires Saint-Luc
Brussels, 1200
Boehringer Ingelheim, 080049616, belgique@bitrialsupport.com
- Suspended
UZ Leuven
Leuven, 3000
France2 sites, 2 recruiting
- Recruiting
INS Paoli-Calmettes
Marseille, 13009
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
- Recruiting
Institut Gustave Roussy
Villejuif, 94800
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
Germany2 sites, 2 recruiting
- Recruiting
Klinikum der Universität München AÖR
München, 81377
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Recruiting
Universitätsklinikum Würzburg AÖR
Würzburg, 97078
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
Japan2 sites, 2 recruiting
- Recruiting
National Cancer Center Hospital East
Chiba, Kashiwa, 277-8577
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Japanese Foundation for Cancer Research
Tokyo, Koto-ku, 135-8550
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
Spain2 sites, 2 recruiting
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Clínica Universidad de Navarra - Madrid
Madrid, 28027
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
About this study
Official title: 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
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.
- Conditions
- Advanced Relapsed or Refractory Germ Cell Tumours, Advanced Relapsed or Refractory Endometrial Cancer, Advanced Relapsed or Refractory Ovarian Cancer
- Being tested
- BI 3820768
- Medical subject headings
- Endometrial Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 3820768Drug
BI 3820768
| Study group | Role | What they receive |
|---|---|---|
| Part 1: BI 3820768 | Experimental | Not described Receives: Drug: BI 3820768 |
| Part 2: BI 3820768 | Experimental | Not described Receives: Drug: BI 3820768 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of treatment-emergent AEs
AEs=Adverse Events
Measured: up to 3 years.
Occurrence of DLT(s)
DLT(s)=Dose Limiting Toxicities
Measured: up to 3 years.
Secondary outcomes (5)
Objective response (OR)
Defined as the best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), where Best overall response (BOR) is determined according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.
Measured: up to 3 years.
Maximum measured plasma concentration of BI 3820768 after the first administration
Measured: up to 24 hours.
Maximum measured plasma concentration of BI 3820768 after multiple administrations
Measured: up to 3 years.
Area under the concentration-time curve of BI 3820768 after the first administration
Measured: up to 24 hours.
Area under the concentration-time curve of BI 3820768 after multiple administrations
Measured: up to 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start27 Feb 2026
- Primary completion7 Sep 2029 (estimated)
- Study completion28 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Relapsed or Refractory Germ Cell TumoursStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 187 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07306559
- Sponsor's protocol ID
- 2001-0001
- Other IDs
- 2025-522913-45-00, U1111-1324-5961, 2025
- Status last verified
- Aug 2026
- First submitted
- 15 Dec 2025
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07306559
- Acronym / sponsor ID
- 2001-0001
- Conditions
- Advanced Relapsed or Refractory Germ Cell Tumours, Advanced Relapsed or Refractory Endometrial Cancer, Advanced Relapsed or Refractory Ovarian Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 187 participants (estimated)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 27 Feb 2026 (actual)
- Primary completion
- 7 Sep 2029 (estimated)
- Study completion
- 28 Jan 2030 (estimated)
- First posted
- 29 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1: BI 3820768 | Experimental | Drug: BI 3820768 |
| Part 2: BI 3820768 | Experimental | Drug: BI 3820768 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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, sampling, or analyses.
- 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.
Key exclusion criteria (14 listed)
- 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:
- 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 prior to the first dose of trial medication are not eligible.
- Patients with Hepatitis-C-Virus (HCV) infection, defined as:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BI 3820768BI 3820768 | Drug | Part 1: BI 3820768, Part 2: BI 3820768 |
Primary outcome
Occurrence of treatment-emergent AEs
Time frame: up to 3 years.
AEs=Adverse Events
Occurrence of DLT(s)
Time frame: up to 3 years.
DLT(s)=Dose Limiting Toxicities
5 secondary outcomes
Objective response (OR)
Time frame: up to 3 years.
Maximum measured plasma concentration of BI 3820768 after the first administration
Time frame: up to 24 hours.
Maximum measured plasma concentration of BI 3820768 after multiple administrations
Time frame: up to 3 years.
Area under the concentration-time curve of BI 3820768 after the first administration
Time frame: up to 24 hours.
Area under the concentration-time curve of BI 3820768 after multiple administrations
Time frame: up to 3 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing
Related trials for Advanced Relapsed or Refractory Germ Cell Tumours
Active, not recruitingPhase 2
Ensartinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With ALK or ROS1 Genomic Alterations (A Pediatric MATCH Treatment Trial)
Advanced Malignant Solid Neoplasm, Malignant Solid Neoplasm
Active, not recruitingPhase 2
Erdafitinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With FGFR Mutations (A Pediatric MATCH Treatment Trial)
Advanced Malignant Solid Neoplasm, Recurrent Childhood Ependymoma
RecruitingPhase 1
A Study of mRNA-4106 or mRNA-4200 Administered Alone or in Combination With Anti-Cancer Agents in Participants With Solid Tumors
Advanced Solid Tumors
Active, not recruitingPhase 1/2
Study Of Entrectinib (Rxdx-101) in Children and Adolescents With Locally Advanced Or Metastatic Solid Or Primary CNS Tumors And/Or Who Have No Satisfactory Treatment Options
Solid Tumors, CNS Tumors
Active, not recruitingPhase 2
Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial)
Advanced Malignant Solid Neoplasm, Ann Arbor Stage III Non-Hodgkin Lymphoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
13 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BI 3820768 in people with Advanced Relapsed or Refractory Germ Cell Tumours and Advanced Relapsed or Refractory Endometrial Cancer, run by Boehringer Ingelheim at 13 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Belgium, France, Germany, Japan and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Boehringer Ingelheim (1-800-243-0127, clintriage.rdg@boehringer-ingelheim.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of treatment-emergent AEs (time frame: up to 3 years.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.