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
New Trial Tests Targeted Therapy for Advanced Solid Tumors with HER2 Mutations
Plain English Summary
A Study to Learn More About How Well Treatment With Sevabertinib (BAY 2927088) 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) is a Phase 2 clinical trial sponsored by Bayer studying Advanced Solid Tumors, HER2 Mutation. This trial tests a new oral medication called sevabertinib (BAY 2927088) for patients with advanced solid tumors that have specific HER2 gene mutations. It is for adults with certain types of solid tumors, including those of the colon, rectum, uterus, cervix, breast, bladder, or biliary tract, who have not responded to or have no other treatment options. Participants will take sevabertinib tablets daily for 3-week cycles until their cancer progresses, they experience severe side effects, or choose to leave the trial. Alternative treatments may include chemotherapy, radiation, surgery, or other targeted therapies depending on the specific cancer type and stage. The trial aims to enroll 111 participants.
Official 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 (sevabertinib) 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 breast, 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.
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults aged 18 and older with a confirmed diagnosis of advanced, unresectable, or metastatic solid tumors (excluding non-small cell lung cancer) that have a specific HER2 gene mutation. Patients must have had prior standard treatments or have no satisfactory alternative options available. Individuals with active brain tumors or severe, uncontrolled illnesses cannot participate. Previous treatment with a HER2 tyrosine kinase inhibitor will exclude participation. This trial is studying Advanced Solid Tumors, HER2 Mutation, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary goal is to see how many patients' tumors shrink or disappear (Objective Response Rate), indicating the drug's effectiveness in controlling the cancer. The specific primary outcome measures are: Objective Response Rate (ORR) per RECIST 1.1 as assessed by BICR (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). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.
Why This Trial Matters
This trial addresses a critical need for new treatments for advanced solid tumors with HER2 mutations, a group of cancers that can be difficult to treat with existing therapies. Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Advanced Solid Tumors, HER2 Mutation, where improved treatment options are needed.
Investor Insight
This trial signals Bayer's investment in targeted oncology therapies for a niche but growing market of HER2-mutated solid tumors, with potential for approval if efficacy and safety are demonstrated. Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.
Is This Trial Right for Me?
Ask your doctor if sevabertinib is a suitable option for your specific cancer type and mutation, and what the potential benefits and risks are. Be prepared for regular clinic visits for medication, physical exams, blood tests, urine samples, and imaging scans to monitor your health and cancer. Understand that treatment continues until the cancer worsens or side effects become unmanageable, and that heart health will be closely monitored. This trial is currently recruiting participants. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: NON_RANDOMIZED
- Model: SINGLE_GROUP
- Masking: NONE
- Enrollment: 111 participants
Interventions
- DRUG: BAY2927088 — tablet, oral
Primary Outcomes
- Objective Response Rate (ORR) per RECIST 1.1 as assessed by BICR (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
- Duration of response (DOR) per RECIST 1.1 as assessed by BICR (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)
- Time to response (TTR) per RECIST 1.1 as assessed by BICR (From first participant enrolled until end of treatment or end of imaging active follow-up (up to approximately 3 years))
- ORR per RECIST 1.1 as assessed by the investigator (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)
- Disease control rate (DCR) per RECIST 1.1 as assessed by BICR (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)
- DCR ≥12 weeks per RECIST 1.1 as assessed by BICR (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)
Full 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; breast 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
Trial Locations
- UAB O'Neal Comprehensive Cancer Center - The Kirklin Clinic of UAB Hospital, Birmingham, Alabama, United States
- City of Hope - Duarte Cancer Center, Duarte, California, United States
- Florida Cancer Specialists & Research Institute - Fort Myers Cancer Center - Gladiolus, Fort Myers, Florida, United States
- Dana-Farber Cancer Institute - Oncology Department, Boston, Massachusetts, United States
- Brigette Harris Cancer Pavilion at Henry Ford Cancer Center - Detroit, Detroit, Michigan, United States
- Profound Research -OMG - TriAtria Cancer Center, Farmington Hills, Michigan, United States
- Cleveland Clinic - Oncology Department, Cleveland, Ohio, United States
- SCRI Oncology Partners, Nashville, Tennessee, United States
- The University of Texas MD Anderson Cancer Center - Texas Medical Center, Houston, Texas, United States
- Gynecology Oncology clinic at UW Medical Center - Montlake, Seattle, Washington, United States
- ...and 10 more locations
Frequently Asked Questions
What is clinical trial NCT06760819?
NCT06760819 is a Phase 2 INTERVENTIONAL study titled "A Study to Learn More About How Well Treatment With Sevabertinib (BAY 2927088) 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)." It is currently recruiting and is sponsored by Bayer. The trial targets enrollment of 111 participants.
What conditions does NCT06760819 study?
This trial investigates treatments for Advanced Solid Tumors, HER2 Mutation. The primary condition under study is Advanced Solid Tumors.
What treatments are being tested in NCT06760819?
The interventions being studied include: BAY2927088 (DRUG). tablet, oral
What does Phase 2 mean for NCT06760819?
Phase 2 trials test whether the treatment works for the intended condition. They involve 100-300 patients and continue to evaluate safety while measuring effectiveness.
What is the current status of NCT06760819?
This trial is currently "Recruiting." It started on 2025-02-13. The estimated completion date is 2027-10-25.
Who is sponsoring NCT06760819?
NCT06760819 is sponsored by Bayer. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT06760819?
The trial aims to enroll 111 participants. The trial is currently recruiting and accepting new participants.
How is NCT06760819 designed?
This is a interventional study, uses non_randomized allocation, follows a single_group design, employs none masking.
What are the primary outcomes being measured in NCT06760819?
The primary outcome measures are: Objective Response Rate (ORR) per RECIST 1.1 as assessed by BICR (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). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06760819 being conducted?
This trial is being conducted at 20 sites, including Birmingham, Alabama; Duarte, California; Fort Myers, Florida; Boston, Massachusetts and 16 more sites (United States, Australia, Canada).
Where can I find official information about NCT06760819?
The official record for NCT06760819 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06760819. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06760819 testing in simple terms?
This trial tests a new oral medication called sevabertinib (BAY 2927088) for patients with advanced solid tumors that have specific HER2 gene mutations. It is for adults with certain types of solid tumors, including those of the colon, rectum, uterus, cervix, breast, bladder, or biliary tract, who have not responded to or have no other treatment options.
Why is this trial significant?
This trial addresses a critical need for new treatments for advanced solid tumors with HER2 mutations, a group of cancers that can be difficult to treat with existing therapies.
What are the potential risks of participating in NCT06760819?
Common side effects may include fatigue, nausea, diarrhea, and skin rash. More serious risks can include heart problems, liver issues, and lung inflammation, which will be closely monitored by the medical team. The treatment may not be effective for everyone, and the cancer could continue to grow or spread. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06760819?
Ask your doctor if sevabertinib is a suitable option for your specific cancer type and mutation, and what the potential benefits and risks are. Be prepared for regular clinic visits for medication, physical exams, blood tests, urine samples, and imaging scans to monitor your health and cancer. Understand that treatment continues until the cancer worsens or side effects become unmanageable, and that heart health will be closely monitored. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06760819 signal from an investment perspective?
This trial signals Bayer's investment in targeted oncology therapies for a niche but growing market of HER2-mutated solid tumors, with potential for approval if efficacy and safety are demonstrated. This is a Phase 2 trial, which is focused on confirming efficacy before larger pivotal studies.
What happens if the treatment in this trial doesn't work?
Participants will take sevabertinib tablets daily for 3-week cycles until their cancer progresses, they experience severe side effects, or choose to leave the trial. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
More Advanced Solid Tumors Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.