BI 3820768 for Ovarian Cancer

Not yet recruiting at 12 trial locations

Overseen By Boehringer Ingelheim

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Boehringer Ingelheim

Disqualifiers: Recent surgery, Other malignancies, Infections, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: up to 3 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called BI 3820768 for individuals with advanced germ cell tumors, endometrial cancer, or ovarian cancer. The main goal is to determine a tolerable dose that might help shrink tumors. Participants will receive the medicine through injections, and researchers will closely monitor their health and any side effects. This trial may suit those whose cancer has progressed despite standard treatments or for whom usual therapies are unsuitable. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial doctors to understand any specific requirements.

Is there any evidence suggesting that BI 3820768 is likely to be safe for humans?

Research shows that BI 3820768 is undergoing its first human trials to treat certain advanced cancers, such as ovarian cancer. This Phase 1 study aims to determine the maximum safe dosage for participants. Detailed safety information remains unavailable as researchers continue to explore potential side effects.

Participants receive the treatment through injections, with doctors closely monitoring their health. They watch for serious health issues and regularly collect blood samples. This careful observation helps researchers understand the treatment's effects and participants' tolerance.

Since BI 3820768 is being used in humans for the first time, no safety data from previous studies exists. However, the study aims to identify the highest tolerable dose, a standard process in early clinical trials. This careful approach prioritizes participant safety while researchers gather more information about the treatment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for ovarian cancer, such as chemotherapy and targeted therapies, work by attacking rapidly dividing cells or specific cancer cell pathways. However, BI 3820768 is unique because it represents a novel approach, potentially targeting cancer cells in a way that existing treatments do not. Researchers are excited about BI 3820768 because it might offer a new mechanism of action that could be more effective or have fewer side effects than current standards. This could lead to improved outcomes for patients with ovarian cancer who have limited options when existing treatments fail.

What evidence suggests that BI 3820768 might be an effective treatment for ovarian cancer?

Research shows that BI 3820768 is a new treatment designed to help the immune system fight cancer. This trial marks the first time BI 3820768 is tested in people, with participants receiving the treatment in different parts of the study. Similar treatments have shown promise; for instance, one study found that immunotherapy was effective for ovarian cancer in many patients. These treatments work by strengthening the body's natural ability to find and destroy cancer cells. Although specific results for BI 3820768 are not yet available, similar therapies have had positive outcomes. The aim is to find a dose that is both effective and safe for patients. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

Adults with advanced germ cell tumours, endometrial cancer, or ovarian cancer qualify for this trial if their previous treatments failed and they have no other treatment options or standard therapy isn't suitable. Participants must be willing to commit up to 3 years if benefiting from the treatment.

Inclusion Criteria

My tumor tested positive for specific markers in a lab test.

I have been diagnosed with a germ cell tumor, embryonal carcinoma, or ovarian cancer.

I am 18 or older and can legally consent.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BI 3820768 as an injection once a week for 2 cycles of 3 weeks each, followed by doses every 3 weeks

up to 3 years

Regular visits with some requiring overnight stays

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BI 3820768

Trial Overview

The study is testing increasing doses of a new immune system-boosting cancer drug called BI 3820768. It's given as an injection once a week for two cycles of three weeks each, then every three weeks. The goal is to find the highest dose patients can tolerate without severe health problems.

How Is the Trial Designed?

Group I: Part 2: BI 3820768 Experimental Treatment 1 Intervention

Group II: Part 1: BI 3820768 Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials

2,566

Recruited

16,150,000+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37906726/

Ofranergene Obadenovec (Ofra-Vec, VB-111) With Weekly ...

Results: Between December 2017 and March 2022, 409 patients were randomly assigned. The median PFS was 5.29 months in the ofra-vec arm and 5.36 ...

2.

medschool.duke.edu

medschool.duke.edu/news/duke-physician-highlights-positive-ovarian-cancer-clinical-trial-results

Duke Physician Highlights Positive Ovarian Cancer ...

The treatment's effects lasted an average of 8.25 months and patients went about seven months without their cancer worsening. MIRV was approved ...

3.

medrxiv.org

medrxiv.org/content/10.1101/2025.06.25.25330320v1.full.pdf

Outcomes of Women with Primary and Second ...

Objective: To compare the characteristics, treatment patterns, and survival outcomes of women with primary ovarian cancer versus second primary ...

4.

ej-med.org

ej-med.org/index.php/ejmed/article/view/2326/2270

A Retrospective Multi-Dataset Analysis

... effectivenessand safety of immunotherapy for ovarian cancer.This study included 3,750 patients with ovarian can-cer, selected based on ...

5.

resources.flatiron.com

resources.flatiron.com/real-world-evidence/powering-a-new-era-of-treatment-with-real-world-insights-on-26k-people-with-ovarian-cancer

Powering a new era of treatment with real-world insights on ...

A comparative real-world effectiveness study found that lower-risk patients experienced significantly longer real-world time to next treatment and progression- ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07306559

A Study to Test How Well Different Doses of BI 3820768 ...

This study is open to adults with advanced germ cell tumours, endometrial cancer, or ovarian cancer whose previous treatments were not ...

7.

go.drugbank.com

go.drugbank.com/unearth/q?c=_score&d=down&page=55&query=tussis+cough+di&searcher=drugs

Advanced Filter

BI 3820768 is a biologic drug. BI 3820768 is under investigation in clinical trial NCT07306559 (A Study to Test How Well Different Doses of BI 3820768 Are ...

8.

clinicaltrials.gov

clinicaltrials.gov/study/NCT6890338

A Study to Assess Anti-Tumor Activity of Intravenously (IV) ...

The purpose of this study is to assess the safety and efficacy of neoadjuvant carboplatin and mirvetuximab soravtansine in participants with folate receptor ...

9.

seer.cancer.gov

seer.cancer.gov/statfacts/html/ovary.html

Cancer Stat Facts: Ovarian Cancer

Lifetime Risk of Developing Cancer: Approximately 1.1 percent of women will be diagnosed with ovarian cancer at some point during their lifetime, based on 2018– ...