NL-OMON53944尚未招募不适用
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 - FIH study of BAY2927088 in participants with advanced NSCLC
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Bayer
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Key General Inclusion Criteria
- •2. 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).
- •3. 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. Participants previously treated with
- •systemic therapy who are known to have acquired an actionable resistance
- •alteration in a gene other than EGFR/HER2 should first be treated with
- •available approved therapy that targets the identified gene alteration prior to
- •enrolling to this study
- •4. 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.
- •5. Measurable disease by RECIST v1.1 with at least one lesion not chosen for
- •biopsyduring 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. Previously irradiated lesions must have shown
- •progression to be considered measurable.
- •6. 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. However,
- •participantsmay be included after discussion with the Sponsor if the laboratory
- •performing the assay is not CLIA or similar certified.
- •8. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •Key Inclusion Criteria specific to Dose Expansion
- •301. Expansion Group A: NSCLC participants with EGFR ex20ins mutation and naïve
- •to EGFR ex20ins-targeted therapy (e.g., mobocertinib, CLN-081, amivantamab,
- •poziotinib). Participants who had prior treatment with EGFR ex20ins-targeted
- •therapy for <= 2 months and stopped treatment due to reasons other than
- •progressive disease are also eligible.
- •401. Expansion Group B1: NSCLC participants with EGFR ex20ins mutation
- •previously treated with EGFR ex20ins-targeted bispecific antibodies (e.g.
- •amivantamab). Prior treatment with EGFR ex20ins-TKIs is exclusionary unless
- •treatment lasted for <= 2 months and was stopped due to reasons other than
- •progressive disease.
- •402. Expansion Group B2: NSCLC participants with EGFR ex20ins mutation treated
- •with no more than one prior EGFR ex20ins-TKI (e.g mobocertinib, CLN-081,
- •poziotinib).
- •501. Expansion Group C: NSCLC participants with a secondary EGFR resistance
- •mutation C797X and naïve to EGFR C797X-targeted TKI therapy. Participants who
- •had prior treatment with EGFR C797X -targeted TKIs for <= 2 months and stopped
- •treatment due to reasons other than progressive disease are also eligible.
- •601. Expansion Group D: NSCLC participants with HER2 activating mutations
排除标准
- •Key General Exclusion Criteria:
- •6. 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.
- •7. 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
- •8. History of spinal cord compression or brain metastases with the following
- •exceptions:
- •a. Participants with treated brain metastases that are asymptomatic at
- •screening and who are off or receiving low-dose of 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.
- •b. Participants with treated brain metastases that are asymptomatic at
- •screening are eligible in Dose Expansion if all of the following criteria are
- •- 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 of corticosteroids (<=10 mg
- •prednisone or equivalent) for 7 days prior to first dose of BAY 2927088.
- •c. 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
- •Key Exclusion Criteria specific to Backfill and Expansion cohorts:
- •101. History or presence of the EGFR T790M mutation.
研究者
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