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XMT-1660

Phase 1

Triple Negative Breast Cancer | Small molecule | Oncology |Day One Biopharmaceuticals, Inc.|Last Updated: Apr 14, 2026

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 Enrollment319
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05377996A Study of XMT-1660 in Participants With Solid TumorsPHASE1 RECRUITING 319Aug 15, 2022May 1, 2027Apr 14, 202626 United States
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Study Endpoints
Primary Endpoints
Frequency of adverse events that are considered dose-limiting toxicities (DLTs) and associated with XMT-1660 during the first cycle of treatment (Dose Escalation)
17 months

Determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of XMT-1660

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

Assess the safety and tolerability of XMT-1660 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)
approximately 3 years

The percentage of patients with a best overall response of 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)
Up to approximately 3 years
Duration of response (DOR) (Dose Escalation and Dose Expansion)
Up to approximately 3 years
Time of maximum observed plasma concentration of XMT-1660 (Tmax) (Dose Expansion)
3 years
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
XMT-1660EXPERIMENTALSingle arm XMT-1660 alone (monotherapy)
Interventions
NameTypeDescription
XMT-1660DRUGXMT-1660 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 Sites26

Inclusion Criteria: * Recurrent or advanced solid tumor and has disease * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Participants in DES must have at least one non-target lesion as defined by RECIST version 1.1. Participants in Backfill Cohorts and EXP must have at least ...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05377996primaryCompletionDate: changed
LOWMay 24, 2026NCT05377996studyFirstPostDate: changed