A first-in-human study to learn how safe BAY 3713372 is and how it works in participants with MTAP-deleted solid tumors

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Bayer AG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

19 Nov 2025 → ongoing

Decision date (initial)

2025-11-04

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2025-520623-24-00

ClinicalTrials.gov

NCT06914128

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Dose response, Safety, Pharmacokinetic, Pharmacodynamic

Dose Escalation (Master and Intervention Cohort 1): To evaluate the safety profile of BAY 3713372 as monotherapy in the selected patient populations with MTAP-deleted solid tumors. - To determine the maximum tolerated dose (MTD) or maximum administrable dose (MAD) and/or a recommended dose for expansion (RDE) of BAY 3713372 in patients with MTAP-deleted solid tumors. - To characterize the pharmacokinetic (PK) profile of BAY 3713372. Dose Expansion (Master, Intervention Cohorts 1 – 6): To evaluate the preliminary anti-tumor activity of BAY 3713372, as monotherapy and/or in combination, in the selected patient populations with MTAP-deleted solid tumors. Dose Expansion (Intervention Cohorts 3, 4 and 6): To determine the RDE of BAY 3713372 in combination with standard of care in the selected patient populations with MTAP -deleted solid tumors.

Secondary objectives 4

1. Dose Escalation (Master and Intervention Cohort 1): To assess the preliminary anti-tumor activity of BAY 3713372 as monotherapy.
2. Dose Expansion (Master, Intervention Cohorts 1 – 6): To evaluate the safety profile of BAY 3713372, as monotherapy and/or in combination, in the selected patient populations with MTAP-deleted solid tumors.
3. Dose Expansion (Master, Intervention Cohorts 1 – 6): To further assess the preliminary anti-tumor activity of BAY 3713372.
4. Dose Expansion (Master, Intervention Cohorts 1 – 4, and 6): To characterize the pharmacokinetic (PK) profile of BAY 3713372 in monotherapy or in combination with additional anti-cancer treatment.

Conditions and MedDRA coding

MTAP-deleted Solid Tumors

Study design 2 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Participant age ≥ 18 years old with solid tumor and at least 1 evaluable lesion as per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1)
2. Homozygous MTAP-deletion identified through molecular testing from a locally certified laboratory.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Exclusion criteria 4

1. 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.
2. 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 based on the investigator’s clinical assessment and discretion.
3. Cardiac history comprising: - History of congestive heart failure Class >II according to the New York Heart Association Functional Classification. - Myocardial infarction less than 6 months before the start of study intervention. - Serious cardiac arrhythmias requiring treatment or any clinically important abnormalities in rhythm, conduction or morphology on resting ECG with the exception of atrial fibrillation which is well-controlled and requires only digoxin or beta blockers.
4. Unstable angina within 4 weeks before start of study intervention.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 9

1. Dose Escalation (Master and Intervention Cohort 1): Number of participants with treatment-emergent adverse events (TEAEs).
2. Dose Escalation (Master and Intervention Cohort 1): Number of participants with treatment-emergent serious adverse events (TESAEs).
3. Dose Escalation (Master and Intervention Cohort 1): Severity of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs).
4. Dose Escalation (Master and Intervention Cohort 1): Incidence of dose-limiting toxicities (DLTs).
5. Dose Escalation (Master and Intervention Cohort 1): Number of participants with DLTs from the first dose of study intervention to the end of Cycle 1 (each cycle is 21 days).
6. Dose Escalation (Master and Intervention Cohort 1): Maximum concentration (Cmax) of the respective dosing interval of BAY 3713372 after single dose and multiple dose administrations.
7. Dose Escalation (Master and Intervention Cohort 1): Area under the curve (AUC) of the respective dosing interval of BAY 3713372 after single dose and multiple dose administrations.
8. Dose Expansion (Master, Intervention Cohorts 1 – 6): Objective response rate (ORR) as determined by the Investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1).
9. Dose Expansion (Intervention Cohorts 3, 4 and 6): Number of participants with DLTs from the first dose of study intervention to the end of Cycle 1 (each cycle is 21 days).

Secondary endpoints 13

1. Dose Escalation (Master and Intervention Cohort 1): Objective response rate (ORR) as determined by the Investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1).
2. Dose Escalation (Master and Intervention Cohort 1): Duration of response (DOR) as determined by the Investigator according to RECIST v1.1.
3. Dose Escalation (Master and Intervention Cohort 1): Progression-free survival (PFS) as determined by the Investigator according to RECIST v1.1.
4. Dose Escalation (Master and Intervention Cohort 1): Time to response (TTR).
5. Dose Expansion (Master, Intervention Cohorts 1 – 6): Number of participants with treatment-emergent adverse events (TEAEs).
6. Dose Expansion (Master, Intervention Cohorts 1 – 6): Number of participants with treatment-emergent serious adverse events (TESAEs).
7. Dose Expansion (Master, Intervention Cohorts 1 – 6): Severity of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs).
8. Dose Expansion (Master, Intervention Cohorts 1, 3, 4, and 6): Incidence of dose-limiting toxicities (DLTs).
9. Dose Expansion (Master, Intervention Cohorts 1 – 6): Duration of response (DOR) as determined by the Investigator according to RECIST v1.1.
10. Dose Expansion (Master, Intervention Cohorts 1 – 6): Progression-free survival (PFS) as determined by the Investigator according to RECIST v1.1.
11. Dose Expansion (Master, Intervention Cohorts 1 – 6): Time to response (TTR).
12. Dose Expansion (Master, Intervention Cohorts 1 – 4, and 6): Maximum concentration (Cmax) of the respective dosing interval of BAY 3713372 after single dose and multiple dose administrations.
13. Dose Expansion (Master, Intervention Cohorts 1 – 4, and 6): Area under the curve (AUC) of the respective dosing interval of BAY 3713372 after single dose and multiple dose administrations.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 6

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Bayer AG

Sponsor organisation

Bayer AG

Address

-

City

Leverkusen

Postcode

51368

Country

Germany

Scientific contact point

Organisation

Bayer AG

Contact name

Therapeutic Area Head

Public contact point

Organisation

Bayer AG

Contact name

Therapeutic Area Head

Third parties 10

Locations

7 EU/EEA countries · 24 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 77 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

7 submissions — initial application plus substantial / non-substantial modifications