2025-522107-18-00招募中2 期
A Phase 2, Open-label, Multicohort, Study of Rinatabart Sesutecan (Rina-S) in Participants with Non-Small Cell Lung Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Genmab A/S
- 入组人数
- 112
- 试验地点
- 64
- 主要终点
- Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as Assessed by Investigator [Time Frame: Approximately 3 years]
研究概览
简要总结
Assess anti-tumor activity of Rina-S monotherapy
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Participant has histologically or cytologically confirmed metastatic or locally advanced NSCLC of adenocarcinoma histology, not amenable to curative surgery or radiotherapy.
- •Participant must have radiological disease progression while on or after receiving the most recent regimen.
- •Participants either may have actionable genetic alterations (AGAs) or no AGAs.
- •Participant has measurable disease according to RECIST v1.
- •Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1 within 7 days of Cycle 1 Day 1.
排除标准
- •Participant has NSCLC with histology other than adenocarcinoma
- •Participant has a past or current malignancy other than the inclusion diagnosis before the planned first dose of trial treatment, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death (eg, 5- year OS ≥ 90%), including, but not limited to, adequately treated cervical carcinoma of stage 1B or less, in situ basal cell or squamous cell skin carcinoma, in situ bladder cancer, ductal carcinoma in situ, or any past malignancy considered cured for ≥ 3 years.
- •Participants with newly identified or known unstable (eg, progressing brain metastases) or symptomatic central nervous system (CNS) metastases or history of carcinomatous meningitis (also known as leptomeningeal disease). Participants with history of spinal cord compression (from disease). Participants with previous CNS-directed therapy (eg, radiotherapy and/or surgery) for brain metastases may participate provided lesion(s) are radiologically stable (ie, without evidence of progression) for at least 28 days by repeat imaging.
研究组 & 干预措施
Rinatabart Sesutecan
Test
干预措施: Rinatabart Sesutecan (Drug)
PEGFILGRASTIM
Auxiliary
干预措施: PEGFILGRASTIM (Drug)
结局指标
主要结局
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as Assessed by Investigator [Time Frame: Approximately 3 years]
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as Assessed by Investigator [Time Frame: Approximately 3 years]
次要结局
- 1.Duration of Response (DOR) per RECIST v1.1 as Assessed by Investigator [Time Frame: Approximately 4 years]
- 2.Disease Control Rate (DCR) per RECIST v1.1 as Assessed by Investigator [Time Frame: Approximately 4 years]
- 3.Progression-free Survival (PFS) [Time Frame: Approximately 4 years]
- 4.Overall Survival (OS) [Time Frame: Approximately 4 years]
- 5.Maximum (Peak) Observed Serum Drug Concentration (Cmax) of Rina-S Related Analytes [Time Frame: Approximately 12 months]
- 6.Time to Reach Maximum (Peak) Serum Drug Concentration (Tmax) of Rina-S Related Analytes[Time Frame: Approximately 12 months]
- 7.Number of Participants with Antidrug Antibodies (ADAs) [Time Frame: Approximately 12 months]
- 8.Number of Participants with Treatment-emergent Adverse Events (TEAEs) [Time Frame: Approximately 4 years]
研究者
Genmab Trial Information
Scientific
Genmab A/S
研究点 (64)
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