Trial: A Study to Learn More About How Well Tr…

Trial Details

Sponsor: Bayer (industry)

Phase: 2

Start date: Feb. 13, 2025

Planned enrollment: 111

Trial ID: NCT06760819

More trial details at ClinicalTrials.gov

Show Summary from Sponsor

Investigational Drug AI Analysis

Show for: BAY2927088

Overview

BAY 2927088, now named sevabertinib and marketed in the United States as Hyrnuo, is an oral HER2-directed tyrosine kinase inhibitor developed by Bayer. It is no longer investigational for its approved U.S. indication: the FDA granted accelerated approval in November 2025 for previously treated HER2-mutant, locally advanced or metastatic non-squamous non-small-cell lung cancer (NSCLC), and expanded the indication in September 2026 to include patients without prior systemic therapy. Continued approval may depend on confirmation of clinical benefit. (fda.gov)

Mechanism of action

Sevabertinib is a reversible inhibitor of HER2 (ERBB2) that also inhibits mutant EGFR while showing relative selectivity over wild-type EGFR. It suppresses HER2 phosphorylation and downstream signaling. Preclinical activity has been demonstrated against HER2 exon 20 insertions, other activating HER2 mutations, and HER2-amplified models. (pmc.ncbi.nlm.nih.gov)

Efficacy

Evidence comes principally from SOHO-01, an open-label, single-arm phase I/II trial:

Previously treated, HER2-targeted-therapy–naïve patients: confirmed objective response rate (ORR) was 71% (95% CI, 59%–82%; n=70), including 2.9% complete responses. Median duration of response was 9.2 months. (accessdata.fda.gov)
Previously treated with a HER2-directed antibody–drug conjugate: ORR was 38% (95% CI, 25%–53%; n=52), including 6% complete responses; median response duration was 7 months. (accessdata.fda.gov)
No previous systemic therapy: ORR was 75% (95% CI, 64%–85%; n=69). Among responders, 73% remained in response for at least six months and 38% for at least 12 months. (fda.gov)

These results are from non-randomized cohorts; randomized confirmatory evidence remains important for establishing effects on progression-free and overall survival.

Safety

Among 136 previously treated patients, the most frequent adverse reactions were diarrhea (87%; grade 3/4, 18%), rash (66%), paronychia (33%), stomatitis (29%), and nausea (21%). Serious adverse reactions occurred in 31%; dose reductions occurred in 28%, and 3.7% discontinued treatment because of adverse reactions. (accessdata.fda.gov)

Important labeled risks include diarrhea, hepatotoxicity, interstitial lung disease/pneumonitis, cardiac dysfunction, ocular toxicity, pancreatic-enzyme elevations, and embryo-fetal toxicity. (accessdata.fda.gov)

TrialFetch AI Analysis

Goal: Evaluate the antitumor activity and safety of sevabertinib in HER2-mutant solid tumors other than non-small cell lung cancer (NSCLC).

Patients: Adults with measurable, locally advanced unresectable or metastatic solid tumors harboring an activating HER2 mutation who have received appropriate standard therapy or lack satisfactory alternatives. Eligible tumor types include colorectal, biliary tract, bladder or urothelial, cervical, endometrial, and other solid cancers; NSCLC is excluded. Prior HER2 tyrosine kinase inhibitor treatment and active brain metastases are exclusion criteria.

Design: Open-label, nonrandomized, single-arm basket study enrolling patients across tumor types. Treatment continues until RECIST 1.1 progression, unacceptable toxicity, or withdrawal.

Treatments: All participants receive oral sevabertinib (BAY 2927088) 20 mg twice daily in repeated 3-week cycles. Sevabertinib is a reversible HER2-directed tyrosine kinase inhibitor that suppresses signaling from activating HER2 mutations. In separate, nonrandomized NSCLC cohorts, confirmed objective response rates ranged from 38% to 75% depending on prior treatment; these results do not establish its efficacy in the non-NSCLC tumors studied here.

Outcomes: The primary endpoint is confirmed objective response rate by RECIST 1.1 on blinded independent central review. Secondary endpoints include response duration and time to response, disease control, progression-free and overall survival, investigator-assessed response measures, adverse events and treatment discontinuations, and patient-reported physical functioning and quality of life.

Burden on patient: Estimated moderate burden. Twice-daily treatment is taken at home, but repeated clinic visits for imaging, cardiac assessments (echocardiography or cardiac MRI and ECG), blood and urine testing, physical examinations, and quality-of-life questionnaires add time and travel. No mandatory research biopsies or intensive pharmacokinetic sampling are described.

Last updated: Sep 2026

Eligibility

Caution: ClinicalTrials.gov appears to have newer eligibility criteria than the version saved here. Review the current criteria in ClinicalTrials.gov.

Show Criteria

Sites (54)

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Macquarie University Hospital - Oncology Department

Sydney, New South Wales, 2109, Australia

No email / No phone

Status: Recruiting

NSW Health - Blacktown Hospital

Blacktown, New South Wales, 2148, Australia

No email / No phone

Status: Recruiting

ICON Cancer Centre - Southport

Southport, Queensland, 4215, Australia

No email / No phone

Status: Recruiting

Queen Elizabeth II Health Sciences Centre - Victoria General Site

Halifax, Nova Scotia, B3H 1V7, Canada

No email / No phone

Status: Recruiting

Princess Margaret Cancer Centre - University Health Network - Department of Medical Oncology and Hematology

Toronto, Ontario, M5G 2C4, Canada

No email / No phone

Status: Recruiting

McGill University Health Centre - Glen Site

Montreal, Quebec, H4A 3J1, Canada

No email / No phone

Status: Recruiting

Fudan University Shanghai Cancer Center - Oncology Department

Shanghai, 200000, China

No email / No phone

Status: Recruiting

Beijing Cancer Hospital - Oncology Department

Beijing, Beijing Municipality, 100142, China

No email / No phone

Status: Recruiting

Peking University First Hospital - Oncology Department

Beijing, Beijing Municipality, 100034, China

No email / No phone

Status: Recruiting

Hunan Cancer Hospital - Oncology Department

Changsha, Hunan, 410013, China

No email / No phone

Status: Recruiting

Zhongshan Hospital, Fudan University - Oncology Department

Shanghai, Shanghai Municipality, 200032, China

No email / No phone

Status: Recruiting

Sir Run Run Shaw Hospital, Zhejiang Univ. School of Medicine - Oncology Department

Hangzhou, Zhejiang, 310016, China

No email / No phone

Status: Recruiting

Rigshospitalet - Kræftbehandling

Copenhagen, Capital Region, 2100, Denmark

No email / No phone

Status: Recruiting

Aarhus University Hospital - Oncology Department

Aarhus N, Central Jutland, 8200, Denmark

No email / No phone

Status: Recruiting

Odense University Hospital - Oncology Department

Odense, Region Syddanmark, 5000, Denmark

No email / No phone

Status: Recruiting

Centre Hospitalier Lyon Sud - Service oncologie medicale

Pierre-Bénite, Auvergne-Rhône-Alpes, 69310, France

No email / No phone

Status: Recruiting

CHU Brest - Hopital La Cavale Blanche - service oncologie medicale

Brest, Brittany Region, 29200, France

No email / No phone

Status: Recruiting

Centre Oscar Lambret - Service Oncologie

Lille, Hauts-de-France, 59000, France

No email / No phone

Status: Recruiting

Institut Bergonie - Unicancer Nouvelle Aquitaine - Service Oncologie medicale

Bordeaux, New Aquitaine, 33000, France

No email / No phone

Status: Recruiting

ICM - Institut du Cancer de Montpellier - Val d'Aurelle - CIPP

Montpellier, Occitanie, 34298, France

No email / No phone

Status: Recruiting

Institut Gustave Roussy - Departement d'Innovation Therapeutique et d'Essais Precoces (DITEP)

Villejuif, Île-de-France Region, 94805, France

No email / No phone

Status: Recruiting

Azienda USL IRCCS di Reggio Emilia_Arcispedale Santa Maria Nuova - S.C. Oncologia Provinciale

Reggio Emilia, 42123, Italy

No email / No phone

Status: Recruiting

Fondazione IRCCS Istituto Nazionale dei Tumori - S. C. Oncologia Medica 1

Milan, 20133, Italy

No email / No phone

Status: Recruiting

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica

Roma, 00168, Italy

No email / No phone

Status: Recruiting

Istituto Europeo di Oncologia s.r.l - Ginecologia Oncologica Medica

Milan, 20141, Italy

No email / No phone

Status: Recruiting

Aichi Cancer Center Hospital

Nagoya, Aichi-ken, 464-8681, Japan

No email / No phone

Status: Recruiting

National Cancer Center Hospital East (NCCHE) - Kashiwa Campus

Kashiwa, Chiba, 277-8577, Japan

No email / No phone

Status: Recruiting

Hokkaido University Hospital

Sapporo, Hokkaido, 060-8648, Japan

No email / No phone

Status: Recruiting

Kindai University Hospital

Sakai, Osaka, 590-0197, Japan

No email / No phone

Status: Recruiting

National Cancer Center Hospital

Chuo-ku, Tokyo, 104-0045, Japan

No email / No phone

Status: Recruiting

The Cancer Institute Hospital of JFCR

Koto-ku, Tokyo, 135-8550, Japan

No email / No phone

Status: Recruiting

Samsung Medical Center - Oncology Department

Seoul, 06351, South Korea

No email / No phone

Status: Recruiting

Asan Medical Center | Oncology

Seoul, Seoul Teugbyeolsi, 05505, South Korea

No email / No phone

Status: Recruiting

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi, 3080, South Korea

No email / No phone

Status: Recruiting

Severance Hospital, Yonsei University Health System - Oncology Department

Seoul, Seoul Teugbyeolsi, 03722, South Korea

No email / No phone

Status: Recruiting

Hospital Universitari Vall D Hebron | Oncologia Medica

Barcelona, 08035, Spain

No email / No phone

Status: Recruiting

Hospital Universitario Fundacion Jimenez Diaz | Oncologia Medica

Madrid, 28040, Spain

No email / No phone

Status: Recruiting

Instituto Oncologico Dr. Rosell S.L. | Oncologia

Barcelona, 08028, Spain

No email / No phone

Status: Recruiting

Institut Catala D'oncologia | Hospitalet | Oncologia

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

No email / No phone

Status: Recruiting

Clinica Universidad De Navarra | Madrid | Oncologia

Madrid, Navarre, 28027, Spain

No email / No phone

Status: Recruiting

Hopitaux Universitaires de Geneve - Oncology Department

Geneva, 1205, Switzerland

No email / No phone

Status: Recruiting

Inselspital Bern - Universitätsklinik für Medizinische Onkologie

Bern, 3010, Switzerland

No email / No phone

Status: Recruiting

Univestitätsspital Zürich (USZ)

Zurich, 8091, Switzerland

No email / No phone

Status: Recruiting

UAB O'Neal Comprehensive Cancer Center - The Kirklin Clinic of UAB Hospital

Birmingham, Alabama, 35233, United States

No email / No phone

Status: Recruiting

City of Hope - Duarte Cancer Center

Duarte, California, 91010, United States

No email / No phone

Status: Recruiting

Florida Cancer Specialists & Research Institute - Fort Myers Cancer Center - Gladiolus

Fort Myers, Florida, 33908, United States

No email / No phone

Status: Recruiting

Dana-Farber Cancer Institute - Oncology Department

Boston, Massachusetts, 02215, United States

No email / No phone

Status: Recruiting

Profound Research -OMG - TriAtria Cancer Center

Farmington Hills, Michigan, 48334, United States

No email / No phone

Status: Recruiting

Cleveland Clinic - Oncology Department

Cleveland, Ohio, 44195, United States

No email / No phone

Status: Recruiting

SCRI Oncology Partners

Nashville, Tennessee, 37203, United States

No email / No phone

Status: Recruiting

The University of Texas MD Anderson Cancer Center - Texas Medical Center

Houston, Texas, 77030, United States

No email / No phone

Status: Recruiting

UW Health Carbone Cancer Center

Madison, Wisconsin, 53792, United States

No email / No phone

Status: Recruiting

Brigette Harris Cancer Pavilion at Henry Ford Cancer Center - Detroit

Detroit, Michigan, 48202, United States

No email / No phone

Status: Withdrawn

Gynecology Oncology clinic at UW Medical Center - Montlake

Seattle, Washington, 98195, United States

No email / No phone

Status: Withdrawn

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

Trial Details

Show Summary from Sponsor

Investigational Drug AI Analysis

Show for: BAY2927088

Overview

Mechanism of action

Efficacy

Safety

Further reading

TrialFetch AI Analysis

Eligibility

Show Criteria

Sites (54)

Macquarie University Hospital - Oncology Department

NSW Health - Blacktown Hospital

ICON Cancer Centre - Southport

Queen Elizabeth II Health Sciences Centre - Victoria General Site

Princess Margaret Cancer Centre - University Health Network - Department of Medical Oncology and Hematology

McGill University Health Centre - Glen Site

Fudan University Shanghai Cancer Center - Oncology Department

Beijing Cancer Hospital - Oncology Department

Peking University First Hospital - Oncology Department

Hunan Cancer Hospital - Oncology Department

Zhongshan Hospital, Fudan University - Oncology Department

Sir Run Run Shaw Hospital, Zhejiang Univ. School of Medicine - Oncology Department

Rigshospitalet - Kræftbehandling

Aarhus University Hospital - Oncology Department

Odense University Hospital - Oncology Department

Centre Hospitalier Lyon Sud - Service oncologie medicale

CHU Brest - Hopital La Cavale Blanche - service oncologie medicale

Centre Oscar Lambret - Service Oncologie

Institut Bergonie - Unicancer Nouvelle Aquitaine - Service Oncologie medicale

ICM - Institut du Cancer de Montpellier - Val d'Aurelle - CIPP

Institut Gustave Roussy - Departement d'Innovation Therapeutique et d'Essais Precoces (DITEP)

Azienda USL IRCCS di Reggio Emilia_Arcispedale Santa Maria Nuova - S.C. Oncologia Provinciale

Fondazione IRCCS Istituto Nazionale dei Tumori - S. C. Oncologia Medica 1

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica

Istituto Europeo di Oncologia s.r.l - Ginecologia Oncologica Medica

Aichi Cancer Center Hospital

National Cancer Center Hospital East (NCCHE) - Kashiwa Campus

Hokkaido University Hospital

Kindai University Hospital

National Cancer Center Hospital

The Cancer Institute Hospital of JFCR

Samsung Medical Center - Oncology Department

Asan Medical Center | Oncology

Seoul National University Hospital

Severance Hospital, Yonsei University Health System - Oncology Department

Hospital Universitari Vall D Hebron | Oncologia Medica

Hospital Universitario Fundacion Jimenez Diaz | Oncologia Medica

Instituto Oncologico Dr. Rosell S.L. | Oncologia

Institut Catala D'oncologia | Hospitalet | Oncologia

Clinica Universidad De Navarra | Madrid | Oncologia

Hopitaux Universitaires de Geneve - Oncology Department

Inselspital Bern - Universitätsklinik für Medizinische Onkologie

Univestitätsspital Zürich (USZ)

UAB O'Neal Comprehensive Cancer Center - The Kirklin Clinic of UAB Hospital

City of Hope - Duarte Cancer Center

Florida Cancer Specialists & Research Institute - Fort Myers Cancer Center - Gladiolus

Dana-Farber Cancer Institute - Oncology Department

Profound Research -OMG - TriAtria Cancer Center

Cleveland Clinic - Oncology Department

SCRI Oncology Partners

The University of Texas MD Anderson Cancer Center - Texas Medical Center

UW Health Carbone Cancer Center

Brigette Harris Cancer Pavilion at Henry Ford Cancer Center - Detroit

Gynecology Oncology clinic at UW Medical Center - Montlake