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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06760819




Registration number
NCT06760819
Ethics application status
Date submitted
18/12/2024
Date registered
7/01/2025
Date last updated
8/01/2025

Titles & IDs
Public title
A Study to Learn More About How Well Treatment with BAY2927088 Tablets Works and How Safe It is in Participants Who Have a Solid Tumor with Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)
Scientific title
A Phase 2 Open-label Basket Study to Evaluate the Efficacy and Safety of Orally Administered Reversible Tyrosine Kinase Inhibitor BAY 2927088 in Participants with Metastatic or Unresectable Solid Tumors with HER2-activating Mutations
Secondary ID [1] 0 0
2024-517419-62-00
Secondary ID [2] 0 0
22752
Universal Trial Number (UTN)
Trial acronym
panSOHO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumors 0 0
HER2 Mutation 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BAY2927088

Experimental: BAY2927088 - Adult participants with metastatic or unresectable solid tumors with HER-2 activating mutations including: colorectal, biliary tract, bladder, cervical, endometrial, and other solid tumor types. Participants will receive BAY2927088 20 mg BID until disease progression per RECICST 1.1, unacceptable toxicity, or until any other withdrawal criteria.

RECIST 1.1 = Response Evaluation Criteria in Solid Tumors, version 1.1; BID: twice a day


Treatment: Drugs: BAY2927088
tablet, oral
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective Response Rate (ORR) per RECIST 1.1 as assessed by BICR
Timepoint [1] 0 0
From start of study intervention until the first documented progression, or death from any cause, or end of study (up to approximately 3 years), whichever comes first
Secondary outcome [1] 0 0
Duration of response (DOR) per RECIST 1.1 as assessed by BICR
Timepoint [1] 0 0
From start of study intervention until the first documented progression, or death from any cause, or end of study (up to approximately 3 years), whichever comes first
Secondary outcome [2] 0 0
Time to response (TTR) per RECIST 1.1 as assessed by BICR
Timepoint [2] 0 0
From first participant enrolled until end of treatment or end of imaging active follow-up (up to approximately 3 years)
Secondary outcome [3] 0 0
ORR per RECIST 1.1 as assessed by the investigator
Timepoint [3] 0 0
From start of study intervention until the first documented progression, or death from any cause, or end of study (up to approximately 3 years), whichever comes first
Secondary outcome [4] 0 0
Disease control rate (DCR) per RECIST 1.1 as assessed by BICR
Timepoint [4] 0 0
From start of study intervention until the first documented progression, or death from any cause, or end of study (up to approximately 3 years), whichever comes first
Secondary outcome [5] 0 0
DCR =12 weeks per RECIST 1.1 as assessed by BICR
Timepoint [5] 0 0
From start of study intervention until the first documented progression, or death from any cause, or end of study (up to approximately 3 years), whichever comes first
Secondary outcome [6] 0 0
Progression-free survival (PFS) per RECIST 1.1 as assessed by BICR
Timepoint [6] 0 0
From start of study intervention until the first documented progression, or death from any cause, or end of study (up to approximately 3 years), whichever comes first
Secondary outcome [7] 0 0
Disease control rate (DCR) per RECIST 1.1 as assessed by the investigator
Timepoint [7] 0 0
From start of study intervention until the first documented progression, or death from any cause, or end of study (up to approximately 3 years), whichever comes first
Secondary outcome [8] 0 0
DCR =12 weeks per RECIST 1.1 as assessed by the investigator
Timepoint [8] 0 0
From start of study intervention until the first documented progression, or death from any cause, or end of study (up to approximately 3 years), whichever comes first
Secondary outcome [9] 0 0
Progression-free survival (PFS) per RECIST 1.1 as assessed by the investigator
Timepoint [9] 0 0
From start of study intervention until the first documented progression, or death from any cause, or end of study (up to approximately 3 years), whichever comes first
Secondary outcome [10] 0 0
DOR per RECIST 1.1 as assessed by the investigator
Timepoint [10] 0 0
From start of study intervention until the first documented progression, or death from any cause, or end of study (up to approximately 3 years), whichever comes first
Secondary outcome [11] 0 0
TTR per RECIST 1.1 as assessed by the investigator
Timepoint [11] 0 0
From first participant enrolled until end of treatment or end of imaging active follow-up (up to approximately 3 years)
Secondary outcome [12] 0 0
Overall survival (OS)
Timepoint [12] 0 0
From start of study intervention until death from any cause, or end of study (up to approximately 3 years), whichever comes first
Secondary outcome [13] 0 0
Number of participants with treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs) per CTCAE v 5.0, categorized by severity, including number of participants who discontinue study treatment due to an AE
Timepoint [13] 0 0
From first participant enrolled until up to 30 days after the last administration of study treatment
Secondary outcome [14] 0 0
Time to deterioration in EORTC QLQ-C30 physical functioning domain score
Timepoint [14] 0 0
Baseline and up until end of treatment or end of imaging active follow-up (up to approximately 3 years)
Secondary outcome [15] 0 0
Change from baseline in EORTC QLQ-C30 physical functioning domain score
Timepoint [15] 0 0
Baseline and up until end of treatment or end of imaging active follow-up (up to approximately 3 years)
Secondary outcome [16] 0 0
Change from baseline in EORTC QLQ-C30 global health status/quality of life (QoL)
Timepoint [16] 0 0
Baseline and up until end of treatment or end of imaging active follow-up (up to approximately 3 years)

Eligibility
Key inclusion criteria
* Documented histologically or cytologically confirmed locally advanced, unresectable or metastatic solid tumor cancer (colorectal carcinoma; biliary tract cancer; bladder and urothelial tract cancer; cervical cancer; endometrial cancer; other solid tumor cancer, excluding NSCLC)
* Participant must be =18 years of age or over the legal age of consent
* Patients who have received prior standard therapy appropriate for their tumor type and stage of disease, or who have no satisfactory alternative treatments
* Documented activating HER2 mutation
* At least one measurable lesion that would qualify as a target lesion by RECIST 1.1 criteria
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Primary diagnosis of non-small cell lung cancer (NSCLC)
* Prior treatment with a HER2 tyrosine kinase inhibitor (TKI)
* Active brain metastases
* Uncontrolled, severe, intercurrent illness

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
3/03/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
25/10/2027
Actual
Sample size
Target
111
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Blacktown Cancer & Haematology Centre - Blacktown
Recruitment hospital [2] 0 0
Macquarie University Hospital - Sydney
Recruitment hospital [3] 0 0
ICON Cancer Centre - Southport - Southport
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2109 - Sydney
Recruitment postcode(s) [3] 0 0
4215 - Southport
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Massachusetts
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
United States of America
State/province [6] 0 0
Washington
Country [7] 0 0
United States of America
State/province [7] 0 0
Wisconsin
Country [8] 0 0
Canada
State/province [8] 0 0
Nova Scotia
Country [9] 0 0
Canada
State/province [9] 0 0
Ontario
Country [10] 0 0
Canada
State/province [10] 0 0
Quebec
Country [11] 0 0
China
State/province [11] 0 0
Beijing
Country [12] 0 0
China
State/province [12] 0 0
Hunan
Country [13] 0 0
China
State/province [13] 0 0
Shanghai
Country [14] 0 0
China
State/province [14] 0 0
Zhejiang
Country [15] 0 0
Denmark
State/province [15] 0 0
Aarhus N
Country [16] 0 0
Denmark
State/province [16] 0 0
Copenhagen
Country [17] 0 0
Denmark
State/province [17] 0 0
Odense C
Country [18] 0 0
France
State/province [18] 0 0
Bordeaux
Country [19] 0 0
France
State/province [19] 0 0
Brest
Country [20] 0 0
France
State/province [20] 0 0
Lille
Country [21] 0 0
France
State/province [21] 0 0
Pierre-Benite
Country [22] 0 0
Italy
State/province [22] 0 0
Milano
Country [23] 0 0
Italy
State/province [23] 0 0
Reggio Emilia
Country [24] 0 0
Italy
State/province [24] 0 0
Roma
Country [25] 0 0
Japan
State/province [25] 0 0
Aichi
Country [26] 0 0
Japan
State/province [26] 0 0
Chiba
Country [27] 0 0
Japan
State/province [27] 0 0
Hokkaido
Country [28] 0 0
Japan
State/province [28] 0 0
Osaka
Country [29] 0 0
Japan
State/province [29] 0 0
Tokyo
Country [30] 0 0
Korea, Republic of
State/province [30] 0 0
Seoul Teugbyeolsi
Country [31] 0 0
Korea, Republic of
State/province [31] 0 0
Seoul
Country [32] 0 0
Spain
State/province [32] 0 0
Barcelona
Country [33] 0 0
Spain
State/province [33] 0 0
Navarra
Country [34] 0 0
Spain
State/province [34] 0 0
Madrid
Country [35] 0 0
Switzerland
State/province [35] 0 0
Bern
Country [36] 0 0
Switzerland
State/province [36] 0 0
Genève
Country [37] 0 0
Switzerland
State/province [37] 0 0
Zürich

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

Ethics approval
Ethics application status

Summary
Brief summary
Researchers are looking for a better way to treat people who have solid tumors with HER2-activating mutations. Before a treatment can be approved for people to take, researchers do clinical trials to better understand its safety and how it works.

In this trial, the researchers want to learn how well BAY2927088 works in people with different types of solid tumors with HER2 mutations. These include tumors in the colon or rectum, the uterus and the cervix (lower part of the uterus), the bladder, and the biliary tract (includes gall bladder and bile ducts) as well as other types of solid tumors with the exception of people with advanced non-small cell lung cancer (NSCLC).

Solid tumors may have specific changes or mutations to a gene called human epidermal growth receptor-2 (HER2). This leads to the formation of an abnormal form of HER2 protein in the cancer cells, resulting in increased cell growth. The study treatment, BAY2927088, is expected to block the abnormal HER2 protein which may stop the spread of cancer.

The trial will include about 111 participants who are at least 18 years old. All the participants will take 20 mg of BAY2927088 as tablets by mouth.

The participants will take treatments in 3-week periods called cycles. These 3-week cycles will be repeated throughout the trial. The participants can take BAY2927088 until their cancer gets worse, until they have medical problems, or until they leave the trial.

During the trial, the doctors will take imaging scans of different parts of the body to study the spread of cancer and will check heart health using echocardiogram or cardiac magnetic resonance imaging (MRI) and electrocardiogram (ECG). The doctors will also take blood and urine samples and do physical examinations to check the participants' health. They will ask questions about how the participants are feeling and if they have any medical problems.
Trial website
https://clinicaltrials.gov/study/NCT06760819
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06760819