BAY2862789 for Non-Small Cell Lung Cancer

No longer recruiting at 36 trial locations

Overseen By Bayer Clinical Trials Contact

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Bayer

Must not be taking: Immunosuppressants, Corticosteroids, Live vaccines, others

Disqualifiers: Transplant, Immunodeficiency, Autoimmune, others

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

Compensation: Varies

Number of Visits: 20

Duration: Several months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial seeks to find a better treatment for individuals with advanced solid tumors, including non-small cell lung cancer (NSCLC). The focus is on testing a new drug, BAY2862789, which activates certain immune cells known as T-cells to fight cancer. The trial will assess the drug's safety, tolerability, behavior in the body, and impact on tumors. Suitable candidates have solid tumors unresponsive to other treatments and can provide a tumor sample. Participants will receive varying doses of the drug to determine the most effective and safe amount. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the chance to be among the first to receive this new drug.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, you cannot have had certain treatments like systemic anti-cancer therapy or investigational agents within 4 weeks before starting the trial. It's best to discuss your specific medications with the study team.

Is there any evidence suggesting that BAY2862789 is likely to be safe for humans?

Previous studies have tested BAY2862789 to assess its safety for humans. This study marks the first use of BAY2862789 in people, aiming to find the optimal dose and understand its effects on the body. As an early-stage trial, limited safety information is available for BAY2862789 at this time.

The study closely monitors participants for any medical problems, known as adverse events, which can range from mild reactions to serious conditions requiring medical attention. The trial will determine the safe dosage and assess how well participants tolerate the drug.

While the safety of BAY2862789 remains partially unknown, the trial will provide crucial information about its effects. Participants will undergo regular health checks, including blood tests, heart health assessments, and scans to evaluate the cancer's response. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

BAY2862789 is unique because it targets non-small cell lung cancer differently than traditional treatments like chemotherapy or immunotherapy. Researchers are excited because BAY2862789 is designed to be taken orally, potentially offering a more convenient and less invasive option compared to intravenous administration of current therapies. This new drug works by inhibiting specific pathways involved in tumor growth, which could lead to more precise targeting of cancer cells and fewer side effects.

What evidence suggests that BAY2862789 might be an effective treatment for non-small cell lung cancer?

Research has shown that BAY2862789 targets T-cells, immune cells that help fight cancer. By blocking a specific enzyme in these cells, BAY2862789 may enhance their activity against tumors. This method relies on the idea that activating T-cells can help the body attack cancer more effectively. Early studies of similar treatments have shown promise in using this approach to treat advanced cancers like non-small cell lung cancer (NSCLC). Although BAY2862789 is new and still under investigation in this trial, its mechanism offers hope for improved cancer control. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

Adults with advanced solid tumors, including non-small cell lung cancer (NSCLC), who have tried all beneficial treatments or find them unsuitable. They must be in good physical condition, agree to use contraception for 6+ months post-treatment, and provide tumor samples. NSCLC patients should've had PD1/L-1 and platinum therapy; those with certain mutations are ineligible.

Inclusion Criteria

Agree to use contraception during the treatment period and for at least 6 months after the last dose of study treatment

I am fully active or restricted in physically strenuous activity but can do light work.

My tumor was tested for specific genetic changes as per guidelines.

Exclusion Criteria

Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment

I have another cancer that is growing or was treated in the last 3 years.

I have new brain metastases found on a recent MRI/CT scan.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

2 visits (in-person)

Treatment

Participants receive BAY2862789 in a dose escalation format to determine the maximum tolerated dose and assess safety and efficacy

Several months

6 visits in the first month, 1-3 visits per month thereafter

Follow-up

Participants are monitored for safety and effectiveness after treatment, with health checks and cancer status assessments

Up to 12 months

Every 12 weeks

Open-label extension (optional)

Participants may continue treatment with BAY2862789 if they benefit from it, beyond the main study duration

What Are the Treatments Tested in This Trial?

Interventions

• BAY2862789

Trial Overview

BAY2862789 is being tested for safety at various doses, tolerability, maximum dose levels, and how it affects the body and tumors. It's a first-in-human study involving two parts: finding an appropriate dose then expanding that dose to more participants as a tablet until disease progression or unacceptable side effects occur.

How Is the Trial Designed?

Group I: Dose Escalation Experimental Treatment 1 Intervention

Participants will take BAY2862789 oral doses.

Who Is Running the Clinical Trial?

Bayer

Lead Sponsor

Trials

2,291

Recruited

25,560,000+

Founded

1863

Headquarters

Leverkusen, Germany

Known For

Pharmaceutical Innovations

Top Products

Aspirin, Aleve, Yaz, Nexavar

Bill Anderson

Bayer

Chief Executive Officer since 2023

BSc in Chemical Engineering from the University of Texas, MSc in Chemical Engineering and Management from MIT

Michael Devoy

Bayer

Chief Medical Officer since 2014

MD, PhD

Published Research Related to This Trial

The serine/threonine kinase GLK/MAP4K3 promotes lung cancer metastasis and cell migration by interacting with the scaffold protein IQGAP1, which is linked to poor prognosis in patients.

In transgenic mice, GLK enhanced distant metastasis, and its mechanism involves phosphorylating IQGAP1, leading to increased cell migration; this suggests that targeting the GLK-IQGAP pathway could be a promising strategy for treating lung cancer recurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MAP4K3/GLK Promotes Lung Cancer Metastasis by Phosphorylating and Activating IQGAP1. Chuang, HC., Chang, CC., Teng, CF., et al.[2021]

Birinapant, an inhibitor of Inhibitor of Apoptosis Proteins (IAPs), was found to be particularly effective in inducing apoptosis in non-small-cell lung cancer (NSCLC) cells that lack the LKB1 tumor suppressor gene, highlighting its potential as a targeted therapy for LKB1-mutated NSCLC.

The study also discovered that combining Birinapant with Ralimetinib, an inhibitor of the p38α pathway, can overcome resistance in NSCLC cells with both LKB1 and KRAS mutations, suggesting a promising therapeutic strategy for this challenging subgroup of lung cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Activity of Birinapant, a SMAC Mimetic Compound, Alone or in Combination in NSCLCs With Different Mutations. Colombo, M., Marabese, M., Vargiu, G., et al.[2020]

High levels of GLK protein were found in lung cancer tissues from patients with non-small cell lung cancer (NSCLC), indicating its potential role in tumor progression.

Elevated GLK levels were associated with a higher risk of cancer recurrence and poorer survival rates after surgery, suggesting that GLK could serve as a new prognostic biomarker for NSCLC patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

GLK/MAP4K3 overexpression associates with recurrence risk for non-small cell lung cancer. Hsu, CP., Chuang, HC., Lee, MC., et al.[2022]

DCLK1 is a kinase that is overexpressed in various gastrointestinal cancers, making it a potential target for cancer treatment.

The study introduces DCLK1-IN-1, the first selective inhibitor for DCLK1/2, which could help researchers better understand the functions of DCLK1 and its role in cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Synthesis and Structure-Activity Relationships of DCLK1 Kinase Inhibitors Based on a 5,11-Dihydro-6H-benzo[e]pyrimido[5,4-b][1,4]diazepin-6-one Scaffold. Ferguson, FM., Liu, Y., Harshbarger, W., et al.[2021]

In a study of 120 advanced non-small-cell lung cancer (NSCLC) patients, LKB1 mutations did not significantly affect progression-free survival (PFS) or overall survival (OS) when treated with second-line chemotherapy (docetaxel or erlotinib) or during prior platinum-based chemotherapy.

The results suggest that LKB1 mutational status may not be a critical factor in determining chemotherapy efficacy in advanced NSCLC, indicating that cytotoxic chemotherapy remains a key treatment approach for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

LKB1 mutations are not associated with the efficacy of first-line and second-line chemotherapy in patients with advanced non-small-cell lung cancer (NSCLC): a post hoc analysis of the TAILOR trial. Vernieri, C., Ganzinelli, M., Rulli, E., et al.[2021]

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Here we review the mechanisms used by DGKs to ameliorate T cell activation and how inhibition could be used to reinvigorate T cell functions in cancer context.

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An open-label, phase 1, first-in-human, dose escalation and expansion study to evaluate the safety, tolerability, maximum tolerated or administered dose, ...

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A First-in-human Study to Learn How Safe the Study Treatment BAY2862789 is, to Find the Best Dose, How it Affects the Body, What Maximum Amount Can be Given, ...

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