Clinical trial NCT06760819: 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)
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Advanced Solid Tumors
HER2 Mutation
Keywords: Colorectal cancer
CRC
Biliary tract cancer
BTC
Bladder cancer
Cervical cancer
Endometrial cancer
Sarcoma
Gastrointestinal stromal tumor
GIST
Breast cancer
Gastrointestinal cancer
GI cancer
Gastric cancer
Esophageal cancer
Gallbladder cancer
Pancreatic cancer
Ovarian Cancer
Salivary cancer
Ampullary cancer
Urothelial cancer
HER2 mutant cancer
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2025-01-07
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

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

Primary outcomes:
measure: Objective Response Rate (ORR) per RECIST 1.1 as assessed by BICR
timeFrame: 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 outcomes:
measure: Duration of response (DOR) per RECIST 1.1 as assessed by BICR
timeFrame: 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
measure: Time to response (TTR) per RECIST 1.1 as assessed by BICR
timeFrame: From first participant enrolled until end of treatment or end of imaging active follow-up (up to approximately 3 years)
measure: ORR per RECIST 1.1 as assessed by the investigator
timeFrame: 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
measure: Disease control rate (DCR) per RECIST 1.1 as assessed by BICR
timeFrame: 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
measure: DCR ≥12 weeks per RECIST 1.1 as assessed by BICR
timeFrame: 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
measure: Progression-free survival (PFS) per RECIST 1.1 as assessed by BICR
timeFrame: 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
measure: Disease control rate (DCR) per RECIST 1.1 as assessed by the investigator
timeFrame: 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
measure: DCR ≥12 weeks per RECIST 1.1 as assessed by the investigator
timeFrame: 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
measure: Progression-free survival (PFS) per RECIST 1.1 as assessed by the investigator
timeFrame: 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
measure: DOR per RECIST 1.1 as assessed by the investigator
timeFrame: 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
measure: TTR per RECIST 1.1 as assessed by the investigator
timeFrame: From first participant enrolled until end of treatment or end of imaging active follow-up (up to approximately 3 years)
measure: Overall survival (OS)
timeFrame: From start of study intervention until death from any cause, or end of study (up to approximately 3 years), whichever comes first
measure: 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
timeFrame: From first participant enrolled until up to 30 days after the last administration of study treatment
measure: Time to deterioration in EORTC QLQ-C30 physical functioning domain score
timeFrame: Baseline and up until end of treatment or end of imaging active follow-up (up to approximately 3 years)
measure: Change from baseline in EORTC QLQ-C30 physical functioning domain score
timeFrame: Baseline and up until end of treatment or end of imaging active follow-up (up to approximately 3 years)
measure: Change from baseline in EORTC QLQ-C30 global health status/quality of life (QoL)
timeFrame: Baseline and up until end of treatment or end of imaging active follow-up (up to approximately 3 years)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Duarte
country: United States
facility: City of Hope - Duarte Cancer Center
state: California
city: Fort Myers
country: United States
facility: Florida Cancer Specialists & Research Institute - Fort Myers Cancer Center - Gladiolus
state: Florida
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Detroit
country: United States
facility: Brigette Harris Cancer Pavilion at Henry Ford Cancer Center - Detroit
state: Michigan
city: Farmington Hills
country: United States
facility: Profound Research -OMG - TriAtria Cancer Center
state: Michigan
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Nashville
country: United States
facility: SCRI Oncology Partners
state: Tennessee
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: Seattle
country: United States
facility: University of Washington Medical Center (UWMC) - Montlake - Gynecology Oncology
state: Washington
city: Madison
country: United States
facility: UW Health - UW Carbone Cancer Center - Medical Oncology Clinic
state: Wisconsin
city: Blacktown
country: Australia
facility: Blacktown Cancer & Haematology Centre
state: New South Wales
city: Sydney
country: Australia
facility: Macquarie University Hospital
state: New South Wales
city: Southport
country: Australia
facility: ICON Cancer Centre - Southport
state: Queensland
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre - Victoria General Site
state: Nova Scotia
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre - University Health Network - Department of Medical Oncology and Hematology
state: Ontario
city: Montreal
country: Canada
facility: McGill University Health Centre - Glen Site
state: Quebec
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital, Zhejiang Univ. School of Medicine
state: Zhejiang
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
city: Aarhus N
country: Denmark
facility: Aarhus University Hospital
city: Copenhagen OE
country: Denmark
facility: Rigshospitalet - Kræftbehandling
city: Odense C
country: Denmark
facility: Odense University Hospital - Oncology Department
city: Bordeaux
country: France
facility: Institut Bergonie - Unicancer Nouvelle Aquitaine - Service Oncologie medicale
city: Brest
country: France
facility: CHU Brest - Hopital La Cavale Blanche - service oncologie medicale
city: Lille
country: France
facility: Centre Oscar Lambret - Service Oncologie
city: Pierre-Benite
country: France
facility: Centre Hospitalier Lyon Sud - Service oncologie medicale
city: Villejuif Cedex
country: France
facility: Institut Gustave Roussy - Departement d'Innovation Therapeutique et d'Essais Precoces (DITEP)
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori - S. C. Oncologia Medica 1
city: Reggio Emilia
country: Italy
facility: Azienda USL IRCCS di Reggio Emilia_Arcispedale Santa Maria Nuova - S.C. Oncologia Provinciale
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica
city: Nagoya
country: Japan
facility: Aichi Cancer Center Hospital
state: Aichi
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East (NCCHE) - Kashiwa Campus
state: Chiba
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: Osakasayama
country: Japan
facility: Kindai University Hospital
state: Osaka
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Koto-ku
country: Japan
facility: The Cancer Institute Hospital of JFCR
state: Tokyo
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: L'Hospitalet de Llobregat
country: Spain
facility: Institut Catala d'Oncologia (ICO) - Hospital Duran i Reynals
state: Barcelona
city: Madrid
country: Spain
facility: Universidad de Navarra - Clinica Universidad de Navarra (CUN) - Madrid
state: Navarra
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron - Vall d'Hebron Institut d'Oncologia (VHIO)
city: Madrid
country: Spain
facility: Fundacion Jimenez Diaz (Clinica de la Concepcion)
city: Bern
country: Switzerland
facility: Inselspital Bern - Universitätsklinik für Medizinische Onkologie
city: Genève
country: Switzerland
facility: Hopitaux Universitaires de Geneve
city: Zürich
country: Switzerland
facility: Univestitätsspital Zürich (USZ)
Study officials:
References: