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

BAY2927088 (generic name: sevabertinib) is an investigational, oral, reversible tyrosine kinase inhibitor (TKI) being developed primarily for tumors with activating HER2 (ERBB2) mutations, especially non-small cell lung cancer (NSCLC). As of May 28, 2025, the FDA accepted an NDA and granted Priority Review for previously treated adults with HER2‑mutant NSCLC; China’s CDE accepted the NDA on July 28, 2025. Regulatory filings were supported by Phase I/II data from the SOHO‑01 trial. A global Phase III first‑line study (SOHO‑02; NCT06452277) and a Phase II basket study in HER2‑mutant solid tumors (panSOHO) are ongoing. (bayer.com)

Mechanism of action

Oral, reversible, non‑covalent TKI that potently inhibits mutant HER2 (including exon 20 insertions and point mutations) and shows selectivity vs wild‑type EGFR; it also targets certain mutant EGFR variants. Preclinical data demonstrate strong activity across HER2 exon 20 insertion variants (e.g., A775insYVMA) and selected point mutations, with in vivo efficacy in HER2‑mutant xenografts. (aacrjournals.org)

Efficacy

Clinical evidence is from the ongoing Phase I/II SOHO‑01 trial (NCT05099172), including an expansion cohort in previously treated, HER2‑mutant NSCLC (dose: 20 mg twice daily):

ASCO 2024 late‑breaking abstract (data cutoff Feb 19, 2024; n=34 treated; 33 evaluable): ORR 70% (23/33; 95% CI 51.3–84.4); disease control rate 82%; median time to response 5.7 weeks; median PFS 8.1 months (95% CI 4.4, not evaluable); median duration of response (DoR) not reached at cutoff. (ascopubs.org)
WCLC 2024 Presidential Symposium presentation (n=44; 43 evaluable): confirmed ORR 72.1% (1 CR, 2.3%); median DoR 8.7 months (95% CI 4.5, NE); median PFS 7.5 months (95% CI 4.4, 12.2). In tumors with HER2 YVMA insertions, ORR 90.0%, DoR 9.7 months, PFS 9.9 months. (bayer.com)
Bayer’s May 2025 Priority Review press release cites investigator‑assessed ORR 70.5% in one expansion cohort (Cohort D) and 35.3% in another (Cohort E) as of Oct 14, 2024 (different cohort definitions within SOHO‑01). (bayer.com)

Note: No Phase III efficacy results have been reported as of October 7, 2025. (bayer.com)

Safety

Across SOHO‑01:

Common treatment‑related adverse events (TRAEs): diarrhea (≈85–86%; grade 3 ≈25%), rash (≈43–47%), and paronychia (≈25%). Grade ≥3 TRAEs were reported in 40.9%; discontinuation due to TRAEs in 6.8% (WCLC 2024 dataset). (bayer.com)
ASCO 2024 reported diarrhea (85%, mostly grade 1–2) and rash (47%, mostly grade 1–2); 3 patients discontinued due to drug‑related AEs. (ascopubs.org)
In the Priority Review press communication, diarrhea was the most common TRAE leading to dose reduction; no interstitial lung disease (ILD) cases were noted in the cited dataset. (bayer.com)

Ongoing trials

SOHO‑02 (NCT06452277): Phase III, first‑line HER2‑mutant advanced NSCLC, sevabertinib vs platinum/pemetrexed + pembrolizumab; primary endpoint PFS by blinded independent central review. Recruiting. (bayer.com)
SOHO‑01 (NCT05099172): Phase I/II, first‑in‑human study in advanced NSCLC with HER2/EGFR mutations; basis for current efficacy/safety data and expedited regulatory designations. (clinicaltrials.bayer.com)
panSOHO (NCT06760819): Phase II basket in metastatic/unresectable HER2‑mutant solid tumors (non‑NSCLC). First patient enrolled March 4, 2025. (bayer.com)

HealthScout AI Analysis

Goal: Evaluate the antitumor activity and safety of the oral reversible tyrosine kinase inhibitor BAY2927088 (sevabertinib) in metastatic or unresectable solid tumors harboring activating HER2 (ERBB2) mutations across multiple tumor types, excluding NSCLC.

Patients: Adults ≥18 years with histologically or cytologically confirmed locally advanced, unresectable or metastatic solid tumors including colorectal, biliary tract, bladder/urothelial, cervical, endometrial, and other solid tumors (NSCLC excluded) with a documented activating HER2 mutation. Patients must have received appropriate prior standard therapies or have no satisfactory alternatives, and have at least one measurable lesion per RECIST 1.1. Exclusions include prior HER2 TKI exposure, active brain metastases, and uncontrolled intercurrent illness.

Design: Phase 2, open-label, non-randomized basket study. Single-arm cohorts by tumor type/mutation with central imaging review; treatment continues until disease progression, unacceptable toxicity, or withdrawal.

Treatments: BAY2927088 (sevabertinib) 20 mg orally twice daily in 3-week cycles. BAY2927088 is an oral, reversible TKI targeting mutant HER2 and EGFR. In early-phase studies in previously treated HER2-mutant NSCLC, it produced high objective response rates (~70% overall; particularly strong in YVMA insertion) with median PFS ~8 months, and a generally manageable safety profile dominated by low-grade diarrhea and rash. The agent has received Breakthrough Therapy designation for HER2-mutant NSCLC and is being evaluated in a Phase 3 NSCLC trial; this study extends evaluation to non-NSCLC HER2-mutant solid tumors.

Outcomes: Primary: Objective response rate per RECIST 1.1 by blinded independent central review. Secondary: Duration of response, time to response, disease control rate (overall and ≥12 weeks), progression-free survival, all by BICR and by investigator; overall survival; safety and tolerability (TEAEs/TESAEs, discontinuations) per CTCAE v5.0; patient-reported outcomes using EORTC QLQ-C30 including time to deterioration and change from baseline in physical functioning and global health status/quality of life.

Burden on patient: Moderate. Treatment is an oral agent with 3-week cycles, which reduces infusion visits; however, participants will undergo regular imaging for response assessment, cardiac monitoring with echocardiogram or cardiac MRI and ECGs, and routine labs and urinalysis typical of targeted therapy trials. No pharmacokinetic-intense sampling or mandatory biopsies are specified, but the need for periodic cardiac assessments and central imaging, along with potential dermatologic and gastrointestinal adverse events requiring management, adds visit frequency beyond standard community practice. Travel and time commitments will reflect q6–9 week imaging schedules early and ongoing safety assessments over approximately 3 years of follow-up or until progression.

Last updated: Oct 2025

Eligibility

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Sites (54)

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Blacktown Cancer & Haematology Centre

Blacktown, New South Wales, 2148, Australia

No email / No phone

Status: Recruiting

Macquarie University Hospital - Oncology Department

Sydney, New South Wales, 2109, 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

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

Fudan University Shanghai Cancer Center - Oncology Department

Shanghai, 200000, China

No email / No phone

Status: Recruiting

Aarhus University Hospital - Oncology Department

Aarhus N, 8200, Denmark

No email / No phone

Status: Recruiting

Rigshospitalet - Kræftbehandling

Copenhagen OE, 2100, Denmark

No email / No phone

Status: Recruiting

Odense University Hospital - Oncology Department

Odense C, 5000, Denmark

No email / No phone

Status: Recruiting

Institut Bergonie - Unicancer Nouvelle Aquitaine - Service Oncologie medicale

Bordeaux, 33000, France

No email / No phone

Status: Recruiting

CHU Brest - Hopital La Cavale Blanche - service oncologie medicale

Brest, 29200, France

No email / No phone

Status: Recruiting

Centre Oscar Lambret - Service Oncologie

Lille, 59000, France

No email / No phone

Status: Recruiting

Institut du Cancer Montpellier (ICM)

Montpellier, 34298, France

No email / No phone

Status: Not yet recruiting

Centre Hospitalier Lyon Sud - Service oncologie medicale

Pierre-Bénite, 69310, France

No email / No phone

Status: Recruiting

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

Villejuif, 94805, France

No email / No phone

Status: Recruiting

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica

Roma, 00168, 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

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

Milan, 20141, Italy

No email / No phone

Status: Not yet 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

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

Sayama, Osaka, 589-8511, 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

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi, 3080, South Korea

No email / No phone

Status: Recruiting

Asan Medical Center - Oncology Department

Seoul, Seoul Teugbyeolsi, 05505, 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

Samsung Medical Center - Oncology Department

Seoul, 06351, South Korea

No email / No phone

Status: Recruiting

Institut Catala d'Oncologia (ICO) -Oncology Department

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

No email / No phone

Status: Recruiting

Clinica Universidad de Navarra-Oncology Service

Madrid, Navarre, 28027, Spain

No email / No phone

Status: Recruiting

Hospital Quiron Dexeus - Oncologia

Barcelona, 08028, Spain

No email / No phone

Status: Not yet recruiting

Hospital Universitario Fundacion Jimenez Diaz- Oncology Service

Madrid, 28040, Spain

No email / No phone

Status: Recruiting

Hospital Universitari Vall d'Hebron- Oncology Service

Barcelona, 08035, Spain

No email / No phone

Status: Recruiting

Univestitätsspital Zürich (USZ)

Zurich, 8091, Switzerland

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

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

Brigette Harris Cancer Pavilion at Henry Ford Cancer Center - Detroit

Detroit, Michigan, 48202, United States

No email / No phone

Status: Withdrawn

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

University of Washington Medical Center (UWMC) - Montlake - Gynecology Oncology

Seattle, Washington, 98195-0001, United States

No email / No phone

Status: Withdrawn

UW Health - UW Carbone Cancer Center - Medical Oncology Clinic

Madison, Wisconsin, 53792, United States

No email / No phone

Status: Recruiting

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

Ongoing trials

Further reading

HealthScout AI Analysis

Eligibility

Show Criteria

Sites (54)

Blacktown Cancer & Haematology Centre

Macquarie University Hospital - Oncology Department

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

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

Fudan University Shanghai Cancer Center - Oncology Department

Aarhus University Hospital - Oncology Department

Rigshospitalet - Kræftbehandling

Odense University Hospital - Oncology Department

Institut Bergonie - Unicancer Nouvelle Aquitaine - Service Oncologie medicale

CHU Brest - Hopital La Cavale Blanche - service oncologie medicale

Centre Oscar Lambret - Service Oncologie

Institut du Cancer Montpellier (ICM)

Centre Hospitalier Lyon Sud - Service oncologie medicale

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

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica

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

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

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

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

Seoul National University Hospital

Asan Medical Center - Oncology Department

Severance Hospital, Yonsei University Health System - Oncology Department

Samsung Medical Center - Oncology Department

Institut Catala d'Oncologia (ICO) -Oncology Department

Clinica Universidad de Navarra-Oncology Service

Hospital Quiron Dexeus - Oncologia

Hospital Universitario Fundacion Jimenez Diaz- Oncology Service

Hospital Universitari Vall d'Hebron- Oncology Service

Univestitätsspital Zürich (USZ)

Hopitaux Universitaires de Geneve - Oncology Department

Inselspital Bern - Universitätsklinik für Medizinische Onkologie

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

Brigette Harris Cancer Pavilion at Henry Ford Cancer Center - Detroit

Profound Research -OMG - TriAtria Cancer Center

Cleveland Clinic - Oncology Department

SCRI Oncology Partners

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

University of Washington Medical Center (UWMC) - Montlake - Gynecology Oncology

UW Health - UW Carbone Cancer Center - Medical Oncology Clinic