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NCT05377996 · ClinicalTrials.gov record · last posted 2026-06-29

A Study of Emiltatug Ledadotin (Emi-Le) in Participants With Solid Tumors

StatusRecruiting
PhasePhase 1/2
Started2022-08-15
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from the ClinicalTrials.gov record
A Study of Emi-Le in Participants with Solid Tumors

Protocol amendment history 6 changes detected by DataLookout

2026-06-30
Phase changed: Phase 1 → Phase 1/2
2026-06-30
Primary endpoint(s) modified
WasFrequency of adverse events that are considered dose-limiting toxicities (DLTs) and associated with XMT-1660 during the first cycle of treatment (Dose Escalation), Incidence of adverse events (Dose Escalation and Dose Expansion), Objective Response Rate (ORR) (Dose Expansion)
NowFrequency of adverse events that are considered dose-limiting toxicities (DLTs) and associated with Emi-Le during the first cycle of treatment (Dose Escalation), Incidence of adverse events (Dose Escalation and Dose Expansion), Objective Response Rate (ORR) (Dose Expansion and EMBLEM-1)
2026-06-30
Enrollment increased: 319 → 360 participants
2026-06-30
Sponsor changed: Mersana Therapeutics → Day One Biopharmaceuticals, Inc.
WasMersana Therapeutics
NowDay One Biopharmaceuticals, Inc.
2026-06-30
Primary completion pushed: 2026-12 → 2027-02
2026-06-30
Completion pushed: 2027-05 → 2027-12
Trial Details
NCT Number NCT05377996
Lead Sponsor Day One Biopharmaceuticals, Inc.
Conditions Triple Negative Breast Cancer, Breast Cancer, Endometrial Cancer, Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cavity Cancer, Adenoid Cystic Carcinoma
Enrollment 360 participants
Start Date 2022-08-15
Primary Completion 2027-02 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2026-06-29