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177Lu--3050

Phase 1

Solid Malignancies | Small molecule | Other |Immunome, Inc.|Last Updated: Apr 6, 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
ACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment105
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07505771A Phase 1 Study of 177Lu-IM-3050 in Participants With Advanced CancerEARLY_PHASE1 RECRUITING 105Apr 1, 2026Dec 1, 2034Apr 6, 20261 United States
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Study Endpoints
Primary Endpoints
Safety and tolerability of 177Lu-IM-3050 in participants with advanced solid tumors as measured by incidence of treatment emergent adverse events (TEAEs)
From first dose of 177Lu-IM-3050 through at least 42 days following last dose of study treatment serious and up to approximately 5 years

Type, frequency, seriousness, and severity of adverse events (AEs) graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria version 5.0, including adverse events (SAEs), AEs leading to discontinuation, and deaths

Determine the recommended dose of 177Lu-IM-3050 for further development
From first dose of 177Lu-IM-3050 to 42 days following last dose of study treatment and up to approximately 5 years

Type, frequency, seriousness, and severity of AEs graded using the NCI-CTCAE criteria version 5.0, including SAEs, AEs leading to discontinuation, and deaths

Secondary Endpoints
Time course of blood radioactivity of 177Lu-IM-3050
Through 42-49 days following last dose of 177Lu-IM-3050
Time course of plasma IM-3050
Through 42-49 days following last dose of 177Lu-IM-3050
Evaluate the preliminary anti-tumor activity of 177Lu-IM-3050 in participants with advanced solid tumors
Week 6 until disease progression or participant discontinuation from study
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
177Lu-IM-3050ACTIVE_COMPARATOR177Lu-IM-3050 administered intravenously on a 6-week cycle
Interventions
NameTypeDescription
177Lu-IM-3050DRUG177Lu-IM-3050 is a FAP-directed radiopharmaceutical
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * ≥18 years of age * Eastern Cooperative Oncology Group performance status (ECOG PS) of 0, 1 or 2 * Histological or cytological diagnosis of a solid tumor * Participants must be refractory to or have relapsed after at least one prior standard therapeutic regimen. Participants mu...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07505771primaryCompletionDate: changed
LOWMay 24, 2026NCT07505771studyFirstPostDate: changed