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NCT05377996 (Emiltatug Ledadotin in Triple Negative Breast Cancer Breast Cancer…): BVCT ex-ante prediction vs. reported outcome

On 14 Apr 2024, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 10 Jan 2025 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically maybe significant yet weak clinical efficacy (low ORR) and commercially probably insufficient.

Clinical Trial

NCTID
NCT05377996
Drug Name
Emiltatug Ledadotin (XMT-1660)
Drug MoA
DAR-6 anti-B7-H4 ADC with an AF-HPA payload
Drug Modality
antibody-drug conjugate (ADC)
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
Triple Negative Breast Cancer Breast Cancer Endometrial Cancer Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Cavity Cancer Adenoid Cystic Carcinoma
Human Patients
319
Sponsor
Mersana Therapeutics
Phase
Phase 1

Prediction of , index 921

Prospective Prediction
Prediction Index
921
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in OS)
Technical Prediction
partial SUCCESS (statistically maybe significant yet weak clinical benefit with high toxicity)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
271 days in advance
Readout Data Interpretation
XMT1660 achieved 19% confirmed ORR for all B7-H4 high patients across all doses (11/57)
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically maybe significant yet weak clinical efficacy (low ORR) and commercially probably insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
A Phase 1/2, First-in-human, Multicenter Study of Emiltatug Ledadotin (Emi-Le) in Participants With Solid Tumors
Phase
Phase 1, Phase 2
Status
Recruiting
Enrollment
360
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
Interventions
DRUG: Emi-Le
Design
Single group · None
Primary purpose
Treatment
Start
2022-08-15
Primary completion
2027-02
Completion
2027-12
Primary outcomes
  • Frequency of adverse events that are considered dose-limiting toxicities (DLTs) and associated with Emi-Le during the first cycle of treatment (Dose Escalation) (17 months)
  • Incidence of adverse events (Dose Escalation and Dose Expansion) (3 years)
  • Objective Response Rate (ORR) (Dose Expansion and EMBLEM-1) (approximately 3 years)

NCT05377996 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials