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1021

Phase 1

Solid Malignancies | Monoclonal antibody | Oncology |Immunome, Inc.|Last Updated: Aug 10, 2026

Target and mechanism

ModalityMonoclonal antibody

Also known as IM-1021, -1021

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment117

FDA Designations

No designations recorded

Clinical trial landscape

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
LOWJul 7, 2026NCT06823167lastUpdatePostDate: changed
LOWJul 7, 2026NCT06823167lastUpdatePostDate: changed
LOWJun 22, 2026NCT06823167lastUpdatePostDate: changed
LOWJun 22, 2026NCT06823167lastUpdatePostDate: changed
LOWMay 26, 2026NCT06823167primaryCompletionDate: changed
LOWMay 24, 2026NCT06823167studyFirstPostDate: changed

Frequently asked questions about 1021

What is IM-1021 used for?

IM-1021 is an investigational monoclonal antibody being developed for the treatment of solid malignancies. It is currently being studied in a Phase 1 clinical trial in participants with advanced cancer, including solid and hematologic malignancies.

What does IM-1021 target?

IM-1021 targets ROR1, a receptor tyrosine kinase expressed on the surface of certain cancer cells. As an antibody-drug conjugate, it is designed to deliver a cytotoxic payload to ROR1-positive tumor cells.

Who is developing IM-1021?

IM-1021 is being developed by Immunome, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol IMNM. The company is conducting a Phase 1 clinical trial to evaluate the drug in patients with advanced cancer.

What phase is IM-1021 in?

IM-1021 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 study is currently recruiting participants with advanced cancer.

What clinical trials is IM-1021 in?

IM-1021 is being evaluated in a Phase 1 study (NCT06823167) titled 'A Phase 1 Study of IM-1021 in Participants With Advanced Cancer.' The trial is recruiting up to 117 participants across the United States, Denmark, France, and Spain.

Is IM-1021 the same as -1021?

Yes, IM-1021 is also known as -1021. Both names refer to the same investigational antibody-drug conjugate targeting ROR1, developed by Immunome, Inc. for the treatment of advanced solid malignancies.