BAY 3713372 for Cancer

Recruiting at 60 trial locations

Overseen By Bayer Clinical Trials Contact

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

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

370 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment, BAY 3713372, for individuals with specific types of solid tumors known as MTAP-deleted cancers. The aim is to determine if this treatment can target and kill cancer cells while sparing healthy cells. Researchers seek to identify the safest and most effective dose and assess the treatment's efficacy over time. This trial may suit individuals with MTAP-deleted tumors who have at least one measurable lesion for tracking improvement. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in humans.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that BAY 3713372 remains in the early stages of human testing. As this is the first study of the treatment in humans, solid information on its safety is limited.

The main goal of current studies is to determine the safety of BAY 3713372 and how the body processes it. Researchers examine the frequency and severity of side effects and assess whether any side effects are serious enough to warrant stopping the treatment.

In this early-stage trial, the treatment undergoes testing to establish a safe dose. Consequently, there may be limited information on how well participants tolerate the treatment. However, careful monitoring of side effects and dose adjustments aim to ensure participant safety. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for cancer?

Most treatments for cancers with MTAP deletions, like certain types of lung and pancreatic cancers, typically focus on chemotherapy or targeted therapies that attack specific cancer growth pathways. But BAY 3713372 is different because it targets the vulnerabilities created by the absence of MTAP, potentially providing a more precise attack on cancer cells. Researchers are excited because BAY 3713372 can be used as a monotherapy or in combination with other treatments, which might enhance its effectiveness and broaden its applicability. Additionally, its unique mechanism of action could lead to improved outcomes for patients with these challenging cancer types.

What evidence suggests that this trial's treatment, BAY 3713372, could be effective for MTAP-deleted solid tumors?

Research has shown that BAY 3713372 targets cancers with MTAP deletions by blocking a protein called PRMT5, which plays a role in many cancers, such as lung and breast cancer. Blocking PRMT5 might help stop cancer cells from growing. Early results suggest that this treatment could target cancer cells while sparing healthy ones. Although more information is needed, this approach appears promising for treating hard-to-treat tumors. Participants in this trial will join various treatment arms, including dose escalation and dose expansion cohorts, to evaluate the safety and efficacy of BAY 3713372 in different cancer types. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Dose Expansion (Intervention Cohort 6) Experimental Treatment 1 Intervention

Dose expansion with BAY 3713372 in combination with other treatments in participants with MTAP-deleted PDAC.

Group II: Dose Expansion (Intervention Cohort 5) Experimental Treatment 1 Intervention

Dose expansion with BAY 3713372 monotherapy in participants with MTAP-deleted pancreatic ductal adenocarcinoma (PDAC).

Group III: Dose Expansion (Intervention Cohort 4) Experimental Treatment 1 Intervention

Dose expansion with BAY 3713372 in combination with other treatments in participants with MTAP-deleted NSCLC.

Group IV: Dose Expansion (Intervention Cohort 3) Experimental Treatment 1 Intervention

Dose expansion with BAY 3713372 in combination with other treatments in participants with MTAP-deleted NSCLC.

Group V: Dose Expansion (Intervention Cohort 2) Experimental Treatment 1 Intervention

Dose expansion with BAY 3713372 monotherapy in participants with MTAP-deleted non-small cell lung cancer (NSCLC).

Group VI: Dose Expansion (Intervention Cohort 1) Experimental Treatment 1 Intervention

Dose expansion with BAY 3713372 monotherapy in selected participants with MTAP-deleted solid tumors.

Group VII: Dose Escalation (Intervention Cohort 1) Experimental Treatment 1 Intervention

For the escalation part, different dose levels of BAY 3713372 administered as monotherapy are planned.

Group VIII: Backfill cohorts in Intervention Cohort 1 (Dose Escalation) Experimental Treatment 1 Intervention

Backfill cohorts may be initiated concurrently with dose escalation cohorts to generate additional safety, pharmacokinetic, and pharmacodynamic data to facilitate the selection of the optimal doses for use in further development.

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

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06914128

A First-in-human Study to Learn How Safe BAY 3713372 is ...

The study treatment, BAY 3713372, is under development to treat MTAP (methylthioadenosine phosphorylase)-deleted solid tumors. It is thought to work by ...

2.

withpower.com

withpower.com/trial/phase-1-neoplasms-2-2025-59641

BAY 3713372 for Cancer

The study treatment, BAY 3713372, is under development to treat MTAP (methylthioadenosine phosphorylase)-deleted solid tumors.

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S2352304225002855

Protein arginine methyltransferase 5 as a novel therapeutic ...

MRTX1719 selectively inhibited PRMT5 and represents a promising therapy for about 10% of MTAP-deleted cancers, including non-small cell lung ...

4.

bayer.com

bayer.com/media/download/d8c8d77e-1261-40a2-91d2-95774bbd7ba1/2025-0055e.rtf

2025-0055e.rtf

BAY3713372 is investigated in a global Phase I first-in-human dose escalation study in patients with MTAP-deleted solid tumors. The clinical program aims to ...

5.

rarecancers.org.au

rarecancers.org.au/knowledgebase/clinical-trials/a-first-in-human-study-to-learn-how-safe-bay-3713372-is-and-how-it-works-in-participants-with-mtap-deleted-solid-tumors/

A First-in-human Study to Learn How Safe BAY 3713372 is ...

The study treatment, BAY 3713372, is under development to treat MTAP (methylthioadenosine phosphorylase)-deleted solid tumors.

6.

clin.larvol.com

clin.larvol.com/trial-detail/NCT06914128

A First-in-human Study to Learn How Safe BAY 3713372 is ...

A First-in-human Study to Learn How Safe BAY 3713372 is and How it Works in Participants With MTAP-deleted Solid Tumors. P1/2. Bayer. N=370. Recruiting.

7.

firstwordpharma.com

firstwordpharma.com/story/5944906

Bayer taps Puhe's PRMT5 inhibitor targeting MTAP-deleted ...

BAY 3713372 specifically targets the PRMT5-MTA complex to exploit tumour vulnerability. Juergen Eckhardt, head of business development and ...