2025-524130-26-00招募中2 期
A Phase 2, Open-label, Multicohort, Study of Rinatabart Sesutecan (Rina S) in Participants With Advanced Gastrointestinal (GI) Cancers
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
- 67
- 试验地点
- 38
- 主要终点
- Confirmed Objective Response Rate (ORR) per RECIST v1.1 as assessed by Investigator
研究概览
简要总结
Evaluate the antitumor activity of Rina-S monotherapy in participants with metastatic colorectal cancer, gastric/gastroesophageal junction cancer or esophageal adenocarcinoma, pancreatic ductal adenocarcinoma, biliary tract cancer, and esophageal squamous cell carcinoma.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Participant has histologically or cytologically confirmed gastrointestinal cancer.
- •Participant has documented metastatic or unresectable disease, not amenable to treatment with curative intent.
- •Participant has measurable disease per the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 at baseline.
- •Participant must have radiological disease progression while on or after receiving the most recent regimen.
- •Participant has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Participant has life expectancy ≥3 months.
- •Participant must be able to provide a newly obtained or archival tissue sample.
- •Participant must have adequate organ and bone marrow function, per laboratory test results prior to Rina-S administration
排除标准
- •Participant has clinically significant non-malignant gastrointestinal disorders, including but not limited to, diarrhea > grade 1, ulcerative colitis, inflammatory bowel disease.
- •Participants with recent (up to 4 weeks) history of significant gastrointestinal bleeding, current cancer related ulcerations, fistula, abscess or recent perforation (within 4 to 6 weeks).
- •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.
- •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).
- •Prior treatment with topoisomerase-1 inhibitor containing antibody-drug conjugate (ADC).
- •Treatment with an anticancer agent within 28 days prior to the first dose of trial treatment.
研究组 & 干预措施
PEGFILGRASTIM
Auxiliary
干预措施: PEGFILGRASTIM (Drug)
Rinatabart Sesutecan
Test
干预措施: Rinatabart Sesutecan (Drug)
结局指标
主要结局
Confirmed Objective Response Rate (ORR) per RECIST v1.1 as assessed by Investigator
Confirmed Objective Response Rate (ORR) per RECIST v1.1 as assessed by Investigator
次要结局
- Duration of Response (DOR) per RECIST v1.1 as assessed by Investigator
- Disease Control Rate (DCR) per RECIST v1.1 as assessed by Investigator
- Progression-free Survival (PFS) per RECIST v1.1 as assessed by Investigator
- Types and incidence and severity of h Treatment-emergent Adverse Events (TEAEs)
- PK parameters of Rina-S related analytes
研究者
Genmab Trial Information
Scientific
Genmab A/S
研究点 (38)
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