Clinical Trials List
2022-02-28 - 2026-12-10
Phase I/II
Not yet recruiting2
Recruiting2
Terminated3
ICD-10C34.90
Malignant neoplasm of unspecified part of unspecified bronchus or lung
ICD-10C34.91
Malignant neoplasm of unspecified part of right bronchus or lung
ICD-10C34.92
Malignant neoplasm of unspecified part of left bronchus or lung
ICD-10C7A.090
Malignant carcinoid tumor of the bronchus and lung
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9162.9
Malignant neoplasm of bronchus and lung, unspecified
An Open Label, First-in-human Study of BAY 2927088 in Participants With Advanced Non-small Cell Lung Cancer (NSCLC) Harboring an EGFR and/or HER2 Mutation
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Trial Applicant
BAYER TAIWAN COMPANY LTD.
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 徐偉勛 無
- CHAO-CHI HO CHAO-CHI HO 無
- 楊景堯 無
- Hsin-Yu Liu 無
- Chia-Chi Lin 無
- Chong-Jen Yu 無
- 廖唯昱 無
- 吳尚俊 無
- 廖斌志 無
- 陳冠宇 無
- 蔡子修 無
- YEN-TING LIN 無
- Jih-Hsiang Lee 無
- JIN-YUAN SHIH 無
- 許嘉林 無
- 朱筱桑 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chih-Hung Chen 無
- Ping-Chih Hsu 無
- Chun-Wei Lu Division of Thoracic Medicine
- Chih-Hsi Kuo 無
- 枋岳甫 無
- Chien-Ying Liu 無
- 柯皓文 無
- 陳宏吉 Division of Thoracic Medicine
- Chih-Liang Wang 無
- 邱立忠 無
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Completed
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Completed
Condition/Disease
Objectives
Test Drug
Active Ingredient
BAY 2927088
BAY 2927088
Dosage Form
Tablet
Tablet
Dosage
20
100
Endpoints
- Number of subjects experiencing treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs), categorized by severity. Number of subjects who discontinued trial treatment due to AEs
- MTD or MAD of BAY 2927088 (including subjects from the backfill portion) during the dose-escalation dose-limiting toxicity (DLT) observation period
- Number of subjects at each dose concentration who experienced a BAY 2927088 administration-related DLT during the DLT observation period of the BAY 2927088 dose escalation (including subjects from the backfill portion)
-PK parameters: Maximum blood concentration (Cmax) and area under the curve (AUC) of BAY 2927088 in individual dose intervals after single and multiple doses
Secondary evaluation indicators
• Trial sponsor's assessment of overall response rate (ORR) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
• Safety/tolerability test indicators described under the primary test indicators, PK described under the primary test indicators, and ORR assessed by the trial host based on RECIST from the BAY 2927088 dose in the dose escalation, backfill and dose expansion parts
Inclution Criteria
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.
Exclusion Criteria
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:
Participants with treated brain metastases that are asymptomatic at screening and who are off or receiving low-dose corticosteroids (≤10 mg prednisone or equivalent) for at least 7 days prior to first dose of BAY 2927088 are eligible to enroll in Dose Escalation and Backfill.
Participants with treated brain metastases that are asymptomatic at screening are eligible in Dose Expansion/Extension (with the exception of Group G) if all of the following criteria are met:
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 BAY2927088.
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.
Expansion Group G only: 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 BAY2927088 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)
The Estimated Number of Participants
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Taiwan
33 participants
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Global
420 participants
