A first-in-human study to learn how safe the study treatment BAY2965501 is, to find the best dose(single drug & combination), how it affects the body, what maximum amount can be given, how it moves into, through and out of the body, and how it acts on different tumors in participants with advanced solid tumors
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 284
- 主要终点
- Number of participants experiencing dose - limiting to xicities ( DLTs ) at each dose level in the dose escalation part of the study
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Have measurable disease per Response evaluation criteria in solid tumors version 1.1 (RECIST 1.1) as assessed by the local site investigator.
- •Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to
- •Participants with histologically confirmed diagnosis of a solid tumor(specifications for the different parts of the study below)will be enrolled onto this study.
- •Dose escalation: All solid cancers, except primary central nervous system cancers.
- •The following tumor types will be recruited to the monotherapy expansion cohorts:
- •oNon-small cell lung cancer(NSCLC)
- •oGastric/Gastroesophageal Junction(GEJ) adenocarcinoma
- •The following tumor types will be recruited to the BAY3965501 and pembrolozmab combination expansion cohorts:
- •oNSCLC: participants with tumors that are TPS score >=50% PDL-1 high (based on local historical testing) and are eligible for standard of care anti-PD(L)-1 monotherapy in the first line incurable treatment setting.
- •oGastric/GEJ adenocarcinoma.
排除标准
- •Previous therapy with a diacylglycerol kinase (DGK) inhibitor.is prohibited for monotherapy cohorts(participants previously treated with BAY2965501 or BAY2862789 must have progressed on that DGK inhibitor (and not discontinued for toxicity) to be eligible for combination).
- •Has received a prior therapeutic regimen containing an anti - PD - 1, anti - PD - L1, or anti PD - L2 agent or an agent directed to another stimulatory or co-inhibitory T - cell receptor (e.g., CTLA - 4, OX 40, CD137) and was discontinued from that treatment due to a Grade 3 or higher infusionrelated adverse event (irAE) .
- •Participants with new brain metastases on screening brain MRI/CT. Previously treated brain metastases that are progressive at screening compared to a brain MRI/CT at least 6 weeks earlier are also excluded. Participants with known previously treated brain metastases, which are radiologically stable compared to a CT/MRI scan at least 6 weeks earlier, clinically stable and without the requirement of steroid treatment for at least 14 days prior to the first dose of study treatment may be eligible.
- •Primary central nervous system malignancy or presence of leptomeningeal disease (i.e., positive cerebrospinal fluid cytology or unequivocal radiological or clinical evidence of leptomeningeal involvement) .
- •Participants with gastrointestinal conditions that may compromise oral absorption such as short bowel syndrome or active tumor-related bowel obstruction with ongoing symptoms compromising absorption over last 6 months.
结局指标
主要结局
Number of participants experiencing dose - limiting to xicities ( DLTs ) at each dose level in the dose escalation part of the study
时间窗: From first dose of study treatment to the end of Cycle 1
Number of participants experiencing dose-limiting toxicities (DLTs) at each dose level in the dose escalation part of the study
Number of participants with treatment - emergent adverse events ( TEAEs ) including treatment - emergent serious adverse events ( TESAEs ) and their severity
时间窗: Up to 90 days after the last administration of study treatment
Number of participants with treatment-emergent adverse events (TEAEs) including treatment-emergent serious adverse events (TESAEs) and their severity
Recommended Phase 2 dose ( RP2D ) of BAY2965501
时间窗: Up to 90 days after the last administration of study treatment
Recommended Phase 2 dose (RP2D) of BAY2965501
Maximum concentration ( Cmax ) of the respective dosing interval of BAY2965501 after single dose
时间窗: From pre - dose up to 24 hours after administration on Cycle 1 Day 1
Maximum concentration (Cmax) of the respective dosing interval of BAY2965501 after single dose
Area under the curve [ AUC ( 0 - 24 ) ] for once daily ( QD ) dosing of BAY2965501 after single dose in Cycle 1
时间窗: From pre - dose up to 24 hours after administration on Cycle 1 Day 1
Area under the curve [AUC (0 - 24)] for once daily (QD) dosing of BAY2965501 after single dose in Cycle 1. If AUC (0 - 24) and AUC (0 - 12) cannot be calculated reliably, it might become necessary to appoint the additional parameter AUC (0 - tlast) as primary variable.
Area under the curve [ AUC ( 0 - 12 ) ] for 2 times daily ( BID ) dosing after single dose in Cycle 1 ( if applicable )
时间窗: From pre - dose up to 24 hours after administration on Cycle 1 Day 1
Area under the curve [AUC (0 - 12)] for 2 times daily (BID) dosing after single dose in Cycle 1 (if applicable). If AUC (0 - 24) and AUC (0 - 12) cannot be calculated reliably, it might become necessary to appoint the additional parameter AUC (0 - tlast) as primary variable.
Maximum concentration ( Cmax, md ) of the respective dosing interval of BAY2965501 after multiple dose
时间窗: From pre - dose up to 24 hours after administration on Cycle 1 Day 15
Maximum concentration (Cmax, md) of the respective dosing interval of BAY2965501 after multiple dose
Area under the curve [ AUC ( 0 - 24 ) md ] for QD dosing of BAY2965501 after multiple dose
时间窗: From pre - dose up to 24 hours after administration on Cycle 1 Day 15
Area under the curve [AUC (0 - 24) md] for QD dosing of BAY2965501 after multiple dose. If AUC (0 - 24) md, AUC (0 - 12) md cannot be calculated reliably, it might become necessary to appoint the additional parameter AUC (0 - tlast) md as primary variable.
Area under the curve [ AUC ( 0 - 12 ) md ] for BID dosing of BAY2965501 after multiple dose ( if applicable )
时间窗: From pre - dose up to 24 hours after administration on Cycle 1 Day 15
Area under the curve [AUC (0 - 12) md] for BID dosing of BAY2965501 after multiple dose (if applicable). If AUC (0 - 24) md, AUC (0 - 12) md cannot be calculated reliably, it might become necessary to appoint the additional parameter AUC (0 - tlast) md as primary variable.
次要结局
未报告次要终点