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IM-1021

Phase 1

Solid Malignancies | Small molecule | Oncology |Immunome, Inc.|Trials Updated: Aug 10, 2026

IM-1021 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Feb 2025

IM-1021 target and mechanism

Molecular targetROR1
Target classAdc
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment190

FDA Designations

No designations recorded

IM-1021 clinical trials

IM-1021 · 1 trial · 2 indications

Phase 1 1
NCT06823167A Phase 1 Study of IM-1021 in Participants With Advanced CancerSolid Malignancies
RECRUITING190 Analytics
PHASE1RECRUITING
A Phase 1 Study of IM-1021 in Participants With Advanced Cancer
Solid MalignanciesUnlock trial analytics

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 AEs graded using the NCI-CTCAE v6.0, including SAEs, AEIs, 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

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part A: IM-1021 Dose EscalationEXPERIMENTALIM-1021 given into the vein (IV; intravenously)
Part B: IM-1021 Monotherapy Dose ExpansionEXPERIMENTALIM-1021 given into the vein (IV; intravenously)

Interventions

NameTypeDescription
IM-1021DRUGIM-1021 is an antibody-drug conjugate
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites24

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 StatesDenmarkFranceSpain
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Recent Changes (Last 90 Days)

MEDIUMAug 11, 2026NCT06823167Enrollment: 117 → 190
MEDIUMAug 11, 2026NCT06823167Enrollment: 117 → 190
MEDIUMAug 11, 2026NCT06823167Enrollment: 117 → 190
LOWAug 3, 2026NCT06823167lastUpdatePostDate: changed
LOWAug 3, 2026NCT06823167lastUpdatePostDate: changed

Frequently asked questions about IM-1021

What is IM-1021?

IM-1021 is an investigational small molecule antibody-drug conjugate being developed by Immunome, Inc. for the treatment of solid malignancies and hematologic malignancies. It is currently in Phase 1 clinical development and is designed to target the ROR1 protein. IM-1021 has not been approved by the FDA.

What does IM-1021 target?

IM-1021 targets ROR1, a receptor tyrosine kinase expressed on tumor cells. It is an antibody-drug conjugate, meaning it uses an antibody to deliver a cytotoxic payload to cells expressing ROR1. This targeted approach aims to concentrate anti-tumor activity on malignant cells while limiting effects on normal tissue.

Who makes IM-1021?

IM-1021 is being developed by Immunome, Inc., a biopharmaceutical company that trades on the Nasdaq under the ticker symbol IMNM. Immunome is the sponsor of the ongoing Phase 1 clinical trial evaluating IM-1021 in patients with advanced cancer.

What phase is IM-1021 in?

IM-1021 is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA for any indication. The single ongoing study is a Phase 1 trial that is currently recruiting participants with advanced solid malignancies and hematologic malignancies.

What clinical trials is IM-1021 in?

IM-1021 is being evaluated in one active clinical trial, NCT06823167, titled A Phase 1 Study of IM-1021 in Participants With Advanced Cancer. The trial is recruiting and plans to enroll 190 participants across the United States, Denmark, France, and Spain. It enrolls adults 18 years and older.

Is IM-1021 the same as 1021?

Yes, IM-1021 is also referred to as 1021. Both names refer to the same investigational small molecule antibody-drug conjugate developed by Immunome, Inc. that targets ROR1 and is being studied in a Phase 1 trial in patients with advanced cancer.