NCT05099172
First in Human Study of BAY2927088 in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations in the Genes of Epidermal Growth Factor Receptor (EGFR) and/or Human Epidermal Growth Factor Receptor 2 (HER2)
Recruiting
PHASE1Ages 18+InterventionalTreatmentBayer
~400 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:BAY2927088_formulation ABAY2927088_formulation B_1BAY2927088_formulation B_2BAY2927088_formulation B_3
At a glance
Recruiting sites
3 of 92 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with treatment-emergent adverse events (TEAEs)
Measured over Up to 30 days after the last administration of study treatment
+13 more outcomes measured
Conditions
NCT05099172
Where you'd take part
This study runs at 92 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Hong Kong United Oncology Centre
Kowloon, Hong Kongno site contact published
Recruiting
IPO Porto
Porto, Portugalno site contact published
Recruiting
Tennessee Oncology - Nashville Centennial Clinic
Nashville, Tennesseeno site contact published
Recruiting
Aichi Cancer Center Hospital
Nagoya, Aichi-ken, Japanno site contact published
Active, not recruiting
AP-HM - Hopital de la Timone - Centre d'Essais en Cancerologie
Marseille, Provence-Alpes-Côte d'Azur Region, Franceno site contact published
Withdrawn
Asan Medical Center | Oncology
Seoul, South Koreano site contact published
Active, not recruiting
AZ Delta | Clinical Trial Center - Pneumology
Roeselare, West Flanders, Belgiumno site contact published
Active, not recruiting
Azienda Ospedaliero Universitaria Parma - SC Oncologia Medica
Parma, Italyno site contact published
Active, not recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
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Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Documented histologically or cytologically confirmed locally advanced NSCLC, not suitable for definitive therapy or recurrent or metastatic NSCLC at screening (small cell or mixed histologies are excluded).
Documented disease progression after treatment with at least one prior systemic therapy for advanced disease. Participants who do not have standard of care access due to any reason, are intolerant to, or are not eligible for standard treatments, may also be eligible.
Adequate archival tumor tissue (ideally taken after last targeted treatment and not older than 6 months) has to be available, either from primary or metastatic sites. If archival material is not available, a fresh tumor biopsy should be performed if feasible and if the procedure poses no significant risk for the participant.
Measurable disease by RECIST v1.1 with at least one lesion not chosen for biopsy during the screening period (if a biopsy is taken during screening) that can be accurately measured at baseline with computed tomography (CT) or magnetic resonance imaging (MRI) and that is suitable for accurate repeated measurements. A biopsied lesion should not be used as a target lesion for RECIST 1.1 tumor assessments (or, for participants in Expansion Group G and Group H, for RANO-BM tumor assessments). Previously irradiated lesions must have shown progression to be considered measurable.
Documented activating EGFR and/or HER2 mutation assessed by a Clinical Laboratory Improvement Amendments (CLIA)-certified (United States \[US\] sites) or an equally accredited (outside of the US) local laboratory.
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
Minimum life expectancy of 12 weeks.
Adequate bone marrow function as assessed by the following laboratory tests to be conducted within 7 days before the first dose of study treatment:
Adequate kidney function as assessed by following laboratory test to be conducted within 7 days before the first dose of study treatment:
Adequate liver function as assessed by following laboratory tests to be conducted within 7 days before the first dose of study treatment:
Exclusion
Treatment with an EGFR tyrosine kinase inhibitor (TKI) ≤ 8 days or 5x the terminal phase, elimination half-lives, whichever is shorter, prior to the first dose of study drug.
Treatment with a systemic anti-cancer treatment (excluding EGFR TKIs as described above) ≤ 14 days prior to the first dose of study drug.
Radiation therapy, stereotactic radiosurgery (SRS) and palliative radiation ≤ 14 days prior to the first dose of study drug.
Treatment with immunotherapy ≤ 28 days prior to the first dose of study drug.
Have any unresolved toxicity of Grade ≥ 2 from previous anti-cancer treatment, except for alopecia and skin pigmentation. Participants with chronic, but stable Grade 2 toxicities may be allowed to enroll after agreement between the Investigator and Sponsor.
Any history of primary brain or leptomeningeal disease (symptomatic or asymptomatic), presence of symptomatic central nervous system (CNS) metastases, or CNS metastases that require local treatment (such as radiotherapy or surgery).
History of spinal cord compression or brain metastases with the following exceptions:
there is no evidence of progression (new or enlarging brain metastases) for at least 4 weeks after CNS-directed treatment, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period.
Participants must be off or receiving low-dose corticosteroids (≤10 mg prednisone or equivalent) for 7 days prior to first dose of sevabertinib. 3. Participants with history of spinal cord compression \>3 months from definitive therapy and stable by imaging (MRI or CT) during the screening period and clinically asymptomatic. 4. Expansion Group G and Group H: Participants with active (new or progressing) clinically stable brain metastases who do not require immediate CNS-directed treatment as per Investigator's judgement and who are off or receiving low-dose corticosteroids (≤10 mg prednisone or equivalent such as ≤ 1.5 mg/day dexamethasone) in the 7 days prior to first dose of sevabertinib are eligible.
History of congestive heart failure (CHF) Class \>II according to the New York Heart Association (NYHA) Functional Classification or serious cardiac arrhythmias requiring treatment (e.g. ventricular arrhythmias, atrial fibrillation) or any clinically important abnormalities in rhythm, conduction or morphology or resting ECG (e.g., complete left bundle branch block, third degree heart block, second degree heart block, PR interval \>250 msec).
Participants with:
Use of strong CYP3A4 inhibitors and inducers from 14 days prior to first administration of study drug.
What this trial measures
- Number of participants with treatment-emergent adverse events (TEAEs)Up to 30 days after the last administration of study treatment
- Number of participants with treatment-emergent serious adverse events (TESAEs)Up to 30 days after the last administration of study treatment
- Severity of TEAEsUp to 30 days after the last administration of study treatment
- Severity of TESAEsUp to 30 days after the last administration of study treatment
- Number of participants who discontinue study treatment due to an AEAbout 4 years (Up to the end of study treatment)
- Maximum tolerated dose (MTD) or maximum administered dose (MAD) of BAY2927088 within the DLT observation period in Dose Escalation (including participants from Backfill qualifying for the MTD population)At the end of Cycle 1 of a 21-day cycle
- Number of participants experiencing dose-limiting toxicities (DLTs) at each dose level associated with administration of BAY2927088 in the DLT observation period in Dose Escalation (including participants from Backfill)At the end of Cycle 1 of a 21-day cycle
In Dose Escalation (including participants from Backfill)
- Cmax of BAY2927088Cycle 1, Day 1 (Cycle duration is 21 days)
Cmax: Maximum/peak concentration
- AUC(0-24) of BAY2927088 for QDCycle 1, Day 1 (Cycle duration is 21 days)
AUC: Area under the concentration vs. time curve. AUC(0-24): AUC from time 0 to 24 hours post dose. QD: Quaque die (once daily)
- AUC(0-12) of BAY2927088 for BIDCycle 1, Day 1 (Cycle duration is 21 days)
If applicable. AUC(0-12): AUC from time 0 to 12 hours post dose. BID: Bis in die, 2 times daily.
- Cmax,md of BAY2927088Cycle 1, Day 15 (Cycle duration is 21 days)
Cmax,md: Cmax after multiple dose administrations
- AUC(0-24)md of BAY2927088 for QDCycle 1, Day 15 (Cycle duration is 21 days)
AUC(0-24)md: AUC(0-24) after multiple dose administrations
- AUC(0-12)md of BAY2927088 for BIDCycle 1, Day 15 (Cycle duration is 21 days)
If applicable AUC(0-12)md: AUC(0-12) after multiple dose administrations
- Overall response rate (ORR) per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1) by blinded independent central review (BICR) in extension partFrom the start of the study treatment up to 12 months