A study to test the safety and effectiveness of BAY 3713372 alone and with drug combination in patients with MTAP-deleted solid tumors

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What is this study about?

This study is looking at a condition called MTAP-deleted solid tumors, which refers to various types of cancer that have a specific genetic change where a gene called MTAP is missing. These tumors can occur in different parts of the body. The main treatment being tested is BAY 3713372, a new medicine taken by mouth in tablet form. This medicine is designed to work in a specific way against cancer cells that have this MTAP gene deletion. In some parts of the study, BAY 3713372 will be tested alone, while in other parts it will be combined with other cancer treatments. These other treatments may include medicines from groups called PD-1/PDL-1 inhibitors, which help the immune system fight cancer, pyrimidine analogues, platinum compounds, and plant alkaloids, which are different types of chemotherapy medicines that work in various ways to stop cancer cells from growing. Some participants may receive placebo.

The purpose of this study is to find out if BAY 3713372 is safe, how it affects the body, what side effects it may cause, and whether it can help treat these types of tumors. The study will also determine the right dose of this medicine to use, both when given alone and when combined with other cancer treatments. Additionally, researchers want to understand how the medicine moves through the body and how it may affect tumor growth.

The study will happen in two main parts. In the first part, called dose escalation, different doses of BAY 3713372 will be tested in small groups of people to find a safe and effective dose. Participants will be closely monitored for any side effects, and blood samples will be taken to measure the levels of the medicine in the body. In the second part, called dose expansion, a larger number of people with specific types of MTAP-deleted tumors will receive the selected dose of BAY 3713372, either alone or combined with other cancer treatments. Throughout the study, participants will have regular check-ups, scans to measure their tumors, and blood tests. The treatment is given in cycles, with each cycle lasting 21 days, and participants may continue treatment as long as it is helping them and not causing unacceptable side effects.

1 Treatment with BAY 3713372

You will receive treatment with BAY 3713372, which is a medication being tested for tumors with a specific genetic change called MTAP-deletion.

The medication will be given either as a coated tablet that you swallow by mouth or through intravenous infusion, which means it will be delivered directly into your vein.

The treatment is organized in cycles, with each cycle lasting 21 days.

The exact dose and schedule will be determined based on which phase of the study you are in.

2 Dose escalation phase

If you are in the dose escalation phase, the main goal is to find the safest and most appropriate dose of BAY 3713372.

During this phase, your safety will be closely monitored, especially during the first cycle of 21 days.

Blood samples will be taken to measure how the medication moves through your body and how your body processes it.

The medical team will watch for any side effects or complications that may occur.

3 Dose expansion phase

If you are in the dose expansion phase, you will receive a dose that has already been tested in earlier participants.

You may receive BAY 3713372 alone or in combination with other standard treatments, depending on which group you are assigned to.

The main purpose of this phase is to see if the medication has an effect on your tumor.

Your tumor will be regularly assessed using imaging tests to check if it is shrinking, staying the same, or growing.

4 Safety monitoring throughout the study

Throughout the entire study, your health and safety will be monitored continuously.

Any side effects, whether mild or serious, will be recorded and assessed by the medical team.

Blood samples will be taken at various times to check how the medication is working in your body.

Your physical condition and ability to perform daily activities will be evaluated using a scale called ECOG performance status.

5 Tumor response assessment

Your tumor will be evaluated using a standard method called RECIST 1.1, which measures changes in tumor size.

The medical team will determine if your tumor has responded to treatment, including whether it has shrunk, remained stable, or grown.

The time it takes for your tumor to respond to treatment and how long the response lasts will be recorded.

These assessments will help determine if the medication is effective.

6 Continuation of treatment cycles

You will continue receiving treatment in 21-day cycles for as long as the medication is helping you and not causing unacceptable side effects.

Each cycle follows the same pattern, with regular visits for medication administration, safety checks, and tumor assessments.

The medical team will decide with you when to continue or stop treatment based on how your body responds and your overall health.

Who Can Join the Study?

    To join this clinical trial, you must meet the following requirements:

  • You must be 18 years of age or older
  • You must have a solid tumor, which is a type of cancer that forms a mass or lump, rather than cancers of the blood
  • You must have at least one tumor that can be measured using imaging scans such as CT or MRI, which allows doctors to track if the treatment is working
  • You must have a specific genetic change in your tumor called homozygous MTAP-deletion, which means both copies of a particular gene called MTAP are missing in your cancer cells. This must be confirmed by laboratory testing at a certified facility
  • Your general health and ability to perform daily activities must be good, rated as 0 or 1 on a scale called the ECOG performance status. This means you are either fully active or able to do light work, but not bedridden
  • Both men and women can participate in this study

Who Cannot Join the Study?

  • The study does not list specific exclusion criteria in the provided information, meaning detailed reasons why patients cannot participate are not available in this document.
  • Generally, clinical trials have requirements about previous treatments, other health conditions, and test results that may prevent participation, but these specific details are not included in the current study information.
  • Patients interested in this study should discuss their individual medical situation with their doctor to determine if they might be eligible to participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
IRCCS Humanitas Research Hospital Rozzano Italy
Katholieke Universiteit te Leuven Leuven Belgium
Hospital Universitario De Navarra Pamplona Spain

Other Sites

Site Name City Country Status
Centre hospitalier universitaire de Liege Liege Belgium
Universitair Ziekenhuis Gent Gent Belgium
Masarykuv Onkologicky Ustav Brno-Stred Czechia
Odense University Hospital Odense Denmark
Karolinska University Hospital Solna Sweden
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Hospital Universitario Quironsalud Madrid Pozuelo De Alarcon Spain
Hospital Hm Nou Delfos Barcelona Spain
University Hospital Olomouc Olomouc Czechia
Rigshospitalet Copenhagen Denmark
Netherlands Cancer Institute Amsterdam The Netherlands
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen Gothenburg Sweden
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Hospital Universitario Virgen De La Victoria Malaga Spain
Ukbjvhffelty Mwzglgj Cebfzch Gawlexasm Groningen The Netherlands
Epqndqd Uhxmprrswzoo Mqetqzx Cbexklm Rmyasgruq (mcfbaze Mug Rotterdam The Netherlands
Ukhddoekua Ow Aqnwehh Edegem Belgium
Hkfdpebp Vawv djcafhib Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
01.11.2025
Czechia Czechia
Recruiting
01.11.2025
Denmark Denmark
Recruiting
01.11.2025
Italy Italy
Recruiting
01.11.2025
Spain Spain
Recruiting
01.11.2025
Sweden Sweden
Recruiting
01.11.2025
The Netherlands The Netherlands
Recruiting
01.11.2025

Trial locations

BAY 3713372 is an experimental medication being tested in this study. It is a new type of drug called a PRMT5 inhibitor, which works by blocking a specific protein in cancer cells. This medication is designed to treat solid tumors that have a specific genetic change called MTAP deletion. In this trial, it will be given either alone or in combination with standard cancer treatments to see how safe it is and whether it can help fight cancer.

MTAP-deleted Solid Tumors – This condition refers to solid tumors that have a specific genetic change where the MTAP gene is missing or deleted. Solid tumors are abnormal masses of tissue that form in various parts of the body and do not contain liquid-filled areas or cysts. The deletion of the MTAP gene affects how tumor cells process certain substances and may influence how the cancer grows. These tumors can occur in different organs and tissues throughout the body. The genetic deletion is identified through laboratory testing of the tumor tissue. This type of tumor represents a specific subgroup of cancers defined by their genetic characteristics rather than their location in the body.

Trial ID:
2025-520623-24-00
NCT ID:
NCT06914128
Trial Phase:
Phase I and Phase II (Integrated) – First administration to humans

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