Phase 3 Study of Futuximab/Modotuximab in Combination With Trifluridine/Tipiracil Versus Trifluridine/Tipiracil Single Agent in Participants With Previously Treated Metastatic Colorectal Cancer
Phase 3
Terminated
NCT05223673
| Condition | Metastatic Colorectal Cancer |
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| Phase | Phase 3 |
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| Sponsor | Institut de Recherches Internationales Servier |
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| Status | Terminated |
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| Enrollment | 7 participants |
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| Interventions | Futuximab/modotuximab, Trifluridine/Tipiracil, Trifluridine/Tipiracil |
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| Start date | Apr 21, 2022 |
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| Completion date | Jun 21, 2023 |
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| Results posted | Mar 5, 2024 |
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Summary
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
Open in BENITIONS
View on ClinicalTrials.gov
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