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-1021

Phase 1

Solid Malignancies | Monoclonal antibody | Other |Immunome, Inc.|Last Updated: Apr 15, 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 Enrollment117
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06823167A Phase 1 Study of IM-1021 in Participants With Advanced CancerPHASE1 RECRUITING 117Feb 26, 2025Feb 1, 2029Apr 15, 202613 United States, Spain
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Study Endpoints
Primary Endpoints
Safety and tolerability of IM-1021 in participants with advanced lymphomas and advanced solid tumors as measured by incidence of treatment emergent adverse events (TEAEs)
From first dose to 37 days following last dose of study treatment

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 serious adverse events (SAEs), AEs of interest (AEI), AEs leading to discontinuation, and deaths

Determine the recommended dose(s) and schedule(s) of IM-1021 for further development
From first dose to 37 days following last dose of study treatment

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 serious adverse events (SAEs), AEs of interest (AEI), AEs leading to discontinuation, and deaths

Secondary Endpoints
Area under the concentration-time curve (AUC) of IM-1021 in participants with advanced lymphomas and advanced solid tumors
Through 30-37 days following last dose of IM-1021 up to end of study
Concentration at end of infusion (Ceoi) of IM-1021 in participants with advanced lymphomas and advanced solid tumors
Through 30-37 days following last dose of IM-1021 up to end of study
Maximum observed concentration (Cmax) of IM-1021 in participants with advanced lymphomas and advanced solid tumors
Through 30-37 days following last dose of IM-1021 up to end of study
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Treatment ArmEXPERIMENTALIM-1021 administered intravenously on a 21-day cycle, at a starting dose of 2 mg/kg.
Interventions
NameTypeDescription
IM-1021BIOLOGICALIM-1021 is an antibody-drug conjugate
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites13

Inclusion Criteria: 1. Informed consent signed by the participant prior to conducting study-specific procedures 2. ≥18 years of age 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 4. Histological or cytological diagnosis of: Part A: advanced B-cell lymphomas or sol...

Countries:United StatesSpain
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06823167primaryCompletionDate: changed
LOWMay 24, 2026NCT06823167studyFirstPostDate: changed