臨床研究等提出・公開システム

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

A study to test how well different doses of BI 3820768 are tolerated by people with advanced cancer (solid tumours)

Ito Kenji

Boehringer Ingelheim

2-1-1, Osaki, Shinagawa-ku, Tokyo

medchiken.jp@boehringer-ingelheim.com

Katakabe Tetsuya

Boehringer Ingelheim

2-1-1, Osaki, Shinagawa-ku, Tokyo

+81-120-189-779

medchiken.jp@boehringer-ingelheim.com

Recruiting

April. 22, 2026

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

1. Patient must be >=18 years of age at the time of signature on the informed consent forms.
2. For patients with endometrial cancer and ovarian cancer who signed and dated the informed consent form for target genetic testing and confirmed positive test result
3. For patients who signed and dated the informed consent form for trial participation.
4. Patients with a histologically or cytologically confirmed diagnosis of germ cell tumour, endometrial cancer or ovarian cancer, and patients who are diagnosed as advanced, relapsed or refractory disease.
5. Patients with disease progression despite conventional treatment, intolerant to or not a candidate for conventional treatment, who have exhausted all established treatment options.
6. Patients without significant impairment of the general condition and with adequate organ function

1. Patient with a history of a major surgery within 28 days prior to the first dose of BI 3820768.
2. Previous or concomitant malignancies other than the specific one treated in this trial within the past 3 years.
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.
5. Patients who are infected with hepatitis B virus or hepatitis C virus, or have a history of such infection, and are deemed ineligible for study participation based on specific test results.

Both

Germ Cell Tumour, Endometrial Cancer and Ovarian Cancer

BI 3820768

- Occurrence of treatment-emergent AEs
- Occurrence of DLT(s)

- Objective response
- Maximum measured plasma concentration of BI 3820768 after the first administration
- Maximum measured plasma concentration of BI 3820768 after multiple administrations
- Area under the concentration-time curve of BI 3820768 after the first administration
- Area under the concentration-time curve of BI 3820768 after multiple administrations

+81-3-3520-0111

Yes

Researchers can refer to http://trials.boehringer-ingelheim.com/ to request access to raw data from our clinical studies.

United States of America/Belgium/France/Germany/Spain