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XMT-2056

Phase 1

HER2-positive Breast Cancer | Small molecule | Oncology |Day One Biopharmaceuticals, Inc.|Last Updated: Jul 11, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment162
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05514717A Study of XMT-2056 in Advanced/Recurrent Solid Tumors That Express HER2PHASE1 RECRUITING 162Jan 24, 2023Apr 1, 2027Jul 11, 202514 United States
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Study Endpoints
Primary Endpoints
Frequency of dose-limiting toxicities (DLTs) associated with XMT-2056 during the first cycle of treatment (Dose Escalation)
15 months

Determine the maximum tolerated dose (MTD) of XMT-2056

Incidence of adverse events (Dose Escalation and Dose Expansion)
3 years

Assess the safety and tolerability of XMT-2056 by determining the number of patients with adverse events from date of first dose to 30 days post last dose.

Objective Response Rate (ORR) (Dose Expansion)
3 years

The percentage of patients with a best overall response of confirmed complete or partial response as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

Secondary Endpoints
Objective Response Rate (ORR) (Dose Escalation)
3 years
Duration of response (DOR) (Dose Escalation and Dose Expansion)
3 years
Disease control rate (DCR) (Dose Escalation and Dose Expansion)
3 years
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
XMT-2056EXPERIMENTALXMT-2056 alone (monotherapy)
Interventions
NameTypeDescription
XMT-2056DRUGXMT-2056 will be administered through a vein in your arm or port catheter (intravenously)
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites14

Inclusion Criteria: * Participant has recurrent or metastatic solid tumors with HER2 expression and has disease progression after treatment, is intolerant to treatment, or is contraindicated with available anti-cancer therapies known to confer benefit, based on investigator's judgement. Note: Parti...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05514717primaryCompletionDate: changed
LOWMay 24, 2026NCT05514717studyFirstPostDate: changed