Immunotherapy with BI 1821736 for Advanced Cancer

No longer recruiting at 9 trial locations

Overseen By Boehringer Ingelheim

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Boehringer Ingelheim

Must not be taking: Corticosteroids, Interferon, Immunotherapy, Tamoxifen

Disqualifiers: Brain metastases, Active infection, others

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

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial seeks to determine the highest dose of a new medicine, BI 1821736, that individuals with advanced solid tumors can tolerate. BI 1821736 is an immunotherapy that employs a special virus to destroy cancer cells and enhance the immune system's ability to combat cancer. Participants will receive this treatment via infusion every three weeks for up to three months. The trial is recruiting individuals with advanced solid tumors who have not responded to other treatments. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

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

You may need to stop certain medications before joining the trial. Specifically, you cannot use systemic corticosteroids, interferon, other immunotherapy agents, or tamoxifen within 3 weeks before the first dose. It's best to discuss your current medications with the trial team to see if any adjustments are needed.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that BI 1821736 is undergoing safety testing in people with advanced solid tumors. The aim is to determine the highest dose patients can tolerate without serious side effects. As this study is in an early phase, it marks the first time BI 1821736 is administered to humans, so limited safety information exists.

In such studies, doctors closely monitor for any unwanted effects to ensure the treatment does not cause serious problems. Early-phase studies help researchers understand how well people tolerate new treatments. Although detailed safety data is not yet available, these early trials are designed to carefully monitor participants and adjust doses as needed to ensure their safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for advanced cancer, which often rely on chemotherapy and targeted therapies, BI 1821736 is a novel immunotherapy. This treatment is unique because it works by harnessing the body's immune system to specifically target and attack cancer cells. Researchers are excited about BI 1821736 because it represents a new mechanism of action, potentially offering a more precise and less toxic approach compared to traditional cancer treatments. This could mean fewer side effects and more effective tumor control for patients with advanced cancer.

What evidence suggests that BI 1821736 might be an effective treatment for advanced cancer?

Research shows that BI 1821736 is a specialized virus designed to target and destroy cancer cells while sparing healthy ones. This treatment uses a virus called VSV-GP to help the immune system recognize and combat cancer. Early studies suggest that BI 1821736 can effectively infect and kill cancer cells in patients with advanced solid tumors. Although researchers are testing BI 1821736 in humans for the first time, its mechanism shows promise in fighting tumors. As research progresses, more information will clarify its potential benefits for patients. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

Adults with advanced solid tumors that have not responded to previous treatments or for whom no treatment is available can join this trial. They must have a tumor lesion suitable for biopsy, normal blood clotting levels, and resolved side effects from past cancer therapies (except certain conditions). Participants need good organ function and an acceptable level of blood cells.

Inclusion Criteria

I have tried all known treatments for my condition without success.

My blood clotting times are normal or I'm on a stable blood thinner dose.

Further inclusion criteria apply

Exclusion Criteria

I have not taken more than 10 mg of prednisone or equivalent daily in the last 3 weeks.

I haven't taken any high-risk medications or have conditions that could complicate a biopsy recently.

I haven't taken interferon, immunotherapy, or tamoxifen recently.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BI 1821736 as an infusion into a vein about every 3 weeks for up to 3 months

12 weeks

Infusion every 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BI 1821736

Trial Overview The trial is testing BI 1821736, a new immunotherapy given as an infusion every three weeks up to three months. It's the first time humans receive this virus-based therapy designed to kill cancer cells and boost the immune system. The highest tolerable dose will be determined while monitoring health and tumor response.

How Is the Trial Designed?

Group I: BI 1821736: Dose escalation cohort Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials

2,566

Recruited

16,150,000+

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.TPS2688

Phase I, open-label, dose-escalation trial investigating the ... A Phase I, open-label, dose-escalation study evaluating the safety and early efficacy of BI 1821736 in patients with advanced solid tumors.

2. pro.boehringer-ingelheim.com pro.boehringer-ingelheim.com/us/inoncology/our-pipeline/vsv-gp

VSV-GP oncolytic virus | Clinical Research | InOncology Discover the current research into VSV-GP oncolytic virus. A tumor-specific therapy engineered to infect and kill malignant cells while sparing normal ones.

3. synapse.patsnap.com synapse.patsnap.com/drug/95de89450f3c43fdbbb2dd8b1a2d4042

BI-1821736 - Drug Targets, Indications, Patents An open-label, Phase I dose escalation and expansion trial to investigate safety and efficacy of BI 1821736 in patients with advanced solid tumors.

4. oncologypipeline.com oncologypipeline.com/apexonco/boehringer-whats-and-whats-out

Boehringer: what's in and what's out? | ApexOnco As for Boehringer's most advanced oncology assets, zongertinib targets a lung cancer ... BI 1831169 & BI 1821736, VSV-GP oncolytic viruses ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10705085/

Real-World Treatment Outcomes and Safety of Afatinib in ... This study aimed to evaluate treatment outcomes and safety of afatinib in patients with squamous cell carcinoma of the lung (LSCC) who ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05839600

A Study to Find a Suitable Dose of BI 1821736 and Test ... The purpose of this study is to find the highest dose of a medicine called BI 1821736 that people with advanced solid tumours can tolerate. BI 1821736 is a type ...

7. pro.boehringer-ingelheim.com pro.boehringer-ingelheim.com/us/inoncology/our-pipeline/vsv-gp/nct05839600-1467.1

NCT05839600 (1467-0001) | InOncology 1467.1: A Phase I, open-label, dose-escalation and expansion trial to investigate safety and efficacy of BI 1821736 (VSV-GP-CD80Fc) in patients with advanced ...

8. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.TPS2689

A phase 1, open-label, dose escalation study on the safety ... This is a first-in-human, open-label dose escalation study of ANK-101 in advanced solid tumors with a planned sample size of 12-36 participants.