BAY 3713372 for Cancer

Recruiting at 14 trial locations

Overseen By Bayer Clinical Trials Contact

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Bayer

Disqualifiers: CNS tumors, Glioblastoma, Cardiac history, others

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

Compensation: Varies

Number of Visits: 35

Duration: Until disease progression or unacceptable toxicity

70 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss your current medications with the study team to get specific guidance.

What is the purpose of this trial?

The study treatment, BAY 3713372, is under development to treat MTAP (methylthioadenosine phosphorylase)-deleted solid tumors. It is thought to work by blocking the protein arginine N-methyltransferase 5 (PRMT5). This may kill the MTAP-deleted cancer cells while sparing the normal cells. The main objective of this first-in-human study is to check if BAY 3713372 is safe for further testing and find the dose that could be used to treat different cancer types that are also MTAP-deleted in future studies. For this, the researchers will study and analyze: * the number of participants who have adverse events after receiving different doses of BAY 3713372 and their severity. * the number of participants who experience dose-limiting toxicities (DLTs) after receiving different doses of BAY 3713372, their severity and how often they happened. A DLT is a pre-defined medical problem caused by a specific dose of a drug that is too severe to continue using that dose. * the total amount of BAY 3713372 in participants' blood (also called AUC) over time after single and multiple doses. * the highest level of BAY 3713372 in participants' blood (also called Cmax) after single and multiple doses. Other than the main objective, researchers will also check for the number of participants who show a response to treatment and how long they live without the cancer getting worse. The study participants will receive BAY 3713372 (starting from low to high doses) in the study, to find the highest safe dose for further testing. Participants may take the study treatment as long as they benefit from the treatment without any severe medical problems. Participants will visit the study site: * at least twice before the treatment starts * multiple times when they start taking the treatment * once after 30 days of receiving the last dose and every 9 weeks after that until the cancer worsens, or the participant stops for any other reason During the study, the doctors and their study team will: * check participants' health by performing tests such as blood and urine tests, and checking heart health using an electrocardiogram * check if the participants' cancer has grown and/or spread using computed tomography (CT) or magnetic resonance imaging (MRI) and, if needed, bone scan * take tumor samples The study doctors and their team will contact the participants every 3 months until 2 years after the last participant's last dose or the end of the study to learn about the participant's health.

Eligibility Criteria

This trial is for individuals with MTAP-deleted solid tumors, such as uterine cancer. Participants will be closely monitored and must visit the study site multiple times. They should not have medical conditions that exclude them from safely receiving BAY 3713372, but specific exclusion criteria are not listed here.

Inclusion Criteria

I have tried all standard treatments for my cancer, or they are not suitable for me.

I am 18 or older with a solid tumor that can be measured for treatment response.

My test shows I have a specific genetic change called MTAP-deletion.

Exclusion Criteria

Previous additional cancer else than the one evaluated in this study within the past 2 years except for basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, superficial bladder tumors, localized prostate cancer or other tumors that in the opinion of the investigator, are considered cured or not immediately life-threatening, and will not interfere with the scientific goals of this study

A marked prolongation of QT/QTc interval at screening (e.g., repeated demonstration of a QTc interval >450 ms). Participants with permanent pacemakers (i.e., a paced rhythm) may be eligible after discussion with the sponsor

I have been diagnosed with glioblastoma multiforme.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

At least 2 visits (in-person)

Treatment

Participants receive BAY 3713372 starting from low to high doses to find the highest safe dose

Until disease progression or unacceptable toxicity

Multiple visits during treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days after last dose, then every 9 weeks until disease progression

Once after 30 days of last dose, then every 9 weeks

Long-term Follow-up

Study doctors contact participants every 3 months to learn about their health

Up to 2 years after the last participant's last dose

Contact every 3 months

Treatment Details

Interventions

• BAY 3713372

Trial Overview BAY 3713372 is being tested to see if it's safe and effective against certain cancers by blocking a protein called PRMT5. The trial involves escalating doses to find the highest safe amount and includes regular health checks, blood tests, heart monitoring, imaging scans like CT or MRI, and possibly bone scans.

Participant Groups

Group I: BAY3713372 monotherapy dose escalation Experimental Treatment 1 Intervention

For escalation part, different dose levels of BAY3713372 are planned.

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

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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