Phase 3 Study of Futuximab/Modotuximab in Combination With Trifluridine/Tipiracil Versus Trifluridine/Tipiracil Single Agent in Participants With Previously Treated Metastatic Colorectal Cancer
3期
提前终止
NCT05223673
| 适应症 | Metastatic Colorectal Cancer |
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| 分期 | 3期 |
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| 申办方 | Institut de Recherches Internationales Servier |
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| 状态 | 提前终止 |
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| 受试者人数 | 7 人 |
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| 干预（药物） | Futuximab/modotuximab, Trifluridine/Tipiracil, Trifluridine/Tipiracil |
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| 开始日期 | 2022年4月21日 |
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| 完成日期 | 2023年6月21日 |
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| 结果公布日 | 2024年3月5日 |
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摘要
This is a randomized phase III study with a safety lead-in part in patients with KRAS/ NRAS and BRAF Wild Type metastatic colorectal cancer who have previously received treatment with oxaliplatin, irinotecan, fluoropyrimidines, anti-VEGF agents and anti-EGFR antibodies. The main objective of the safety lead-in part is to assess safety and tolerability of futuximab/modotuximab in combination with trifluridine/tipiracil. The primary objective of the phase III part is to compare Overall Survival of futuximab/modotuximab in combination with trifluridine/tipiracil vs trifluridine/tipiracil monotherapy in patients with tumours that are KRAS/NRAS and BRAF wild-type (WT).
Incidence of Dose-limiting Toxicities (DLTs) (Safety Lead-In Part)
End of cycle 1 (Each cycle is up to 28 days) · dose-limiting toxicities (DLTs)
| Futuximab/Modotuximab Combined With Trifluridine/Tipiracil (Safety Lead-In and Phase III Parts) | 0 dose-limiting toxicities (DLTs) |
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Overall Survival (OS) (In Double Negative, KRAS/NRAS and BRAF Wild Type Patients) (Phase III Part)
up to 4 years 9 months
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