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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06914128




Registration number
NCT06914128
Ethics application status
Date submitted
31/03/2025
Date registered
6/04/2025

Titles & IDs
Public title
A First-in-human Study to Learn How Safe BAY 3713372 is and How it Works in Participants With MTAP-deleted Solid Tumors
Scientific title
A First-in-human Study to Evaluate the Safety, Tolerability and Pharmacokinetics, Pharmacodynamics and Preliminary Clinical Activity of BAY 3713372, a Novel 2nd Generation PRMT5 Inhibitor, in Participants With MTAP-deleted Solid Tumors.
Secondary ID [1] 0 0
2025-520623-24-00
Secondary ID [2] 0 0
22931
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
MTAP-deleted Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BAY3713372

Experimental: BAY3713372 monotherapy dose escalation - For escalation part, different dose levels of BAY3713372 are planned.


Treatment: Drugs: BAY3713372
Daily oral administration
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with treatment-emergent adverse events (TEAEs)
Timepoint [1] 0 0
From the first administration of study intervention up to 30 days after the last dose of study intervention
Primary outcome [2] 0 0
Number of participants with treatment-emergent serious adverse events (TESAEs)
Timepoint [2] 0 0
From the first administration of study intervention up to 30 days after the last dose of study intervention
Primary outcome [3] 0 0
Severity of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs)
Timepoint [3] 0 0
From the first administration of study intervention up to 30 days after the last dose of study intervention
Primary outcome [4] 0 0
Incidence of dose-limiting toxicities (DLTs)
Timepoint [4] 0 0
From first dose of study intervention to the end of Cycle 1 (each cycle is 21 days)
Primary outcome [5] 0 0
Number of participants with DLTs
Timepoint [5] 0 0
From first dose of study intervention to the end of Cycle 1 (each cycle is 21 days)
Primary outcome [6] 0 0
Maximum concentration (Cmax) of the respective dosing interval of BAY 3713372
Timepoint [6] 0 0
From the first dose of study intervention up to Cycle 2 Day 1 (each cycle is 21 days)
Primary outcome [7] 0 0
Area under the curve (AUC) of the respective dosing interval of BAY 3713372
Timepoint [7] 0 0
From the first dose of study intervention up to Cycle 2 Day 1 (each cycle is 21 days)
Secondary outcome [1] 0 0
Objective response rate (ORR)
Timepoint [1] 0 0
Approximately 1.5 years
Secondary outcome [2] 0 0
Duration of response (DOR)
Timepoint [2] 0 0
Approximately 3 years
Secondary outcome [3] 0 0
Progression-free survival (PFS)
Timepoint [3] 0 0
Approximately 3 years
Secondary outcome [4] 0 0
Time to response (TTR)
Timepoint [4] 0 0
Approximately 1.5 years

Eligibility
Key inclusion criteria
* 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)
* Homozygous MTAP-deletion identified through molecular testing from a locally certified laboratory.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Participants must have exhausted available standard of care treatments known to be beneficial for this tumor type or for whom these treatments are not acceptable and for whom this trial is a reasonable option
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.
* Presence of central nervous system (CNS) tumors including progressing, novel and/or symptomatic metastatic brain disease.
* Presence of glioblastoma multiforme (GBM).
* 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.
* 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.
* Unstable angina or new-on major surgery, open biopsy, or significant trauma within 4 weeks before start of study intervention.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/03/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
17/06/2029
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
Concord Repatriation General Hospital (CRGH) (Concord Hospital) - Concord Cancer Centre - Concord
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2139 - Concord
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Michigan
Country [4] 0 0
United States of America
State/province [4] 0 0
Tennessee
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
Singapore
State/province [6] 0 0
Singapore
Country [7] 0 0
United Kingdom
State/province [7] 0 0
Greater London
Country [8] 0 0
United Kingdom
State/province [8] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bayer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Bayer Clinical Trials Contact
Address 0 0
Country 0 0
Phone 0 0
(+)1-888-84 22937
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06914128