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177Lu-IM-3050

Phase 1

Solid Malignancies | Small molecule | Oncology |Immunome, Inc.|Trials Updated: Oct 7, 2026

Development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Apr 2026

Target and mechanism

Molecular targetFAP
ModalitySmall molecule

Also known as 177Lu-3050

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment105

FDA Designations

No designations recorded

Clinical trial landscape

177Lu-IM-3050 · 1 trial · 1 indication

Phase 1 1
NCT07505771A Phase 1 Study of 177Lu-IM-3050 in Participants With Advanced CancerSolid Malignancies
RECRUITING105 Analytics
PHASE1RECRUITING
A Phase 1 Study of 177Lu-IM-3050 in Participants With Advanced Cancer
Solid MalignanciesUnlock trial analytics

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; 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 6.0, 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; up to approximately 5 years

Type, frequency, seriousness, and severity of AEs graded using the NCI-CTCAE criteria version 6.0, 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

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Dose Escalation: 177Lu-IM-3050EXPERIMENTAL177Lu-IM-3050 administered intravenously on a 6-week cycle
Dose Expansion: 177Lu-IM-3050EXPERIMENTAL177Lu-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 to N/A
SexALL
Healthy VolunteersNo
Study Sites5

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)

LOWOct 7, 2026NCT07505771lastUpdatePostDate: changed
LOWOct 7, 2026NCT07505771lastUpdatePostDate: changed
LOWSep 17, 2026NCT07505771Phase: EARLY_PHASE1 → PHASE1
LOWSep 17, 2026NCT07505771Phase: EARLY_PHASE1 → PHASE1
LOWSep 8, 2026NCT07505771lastUpdatePostDate: changed
LOWSep 8, 2026NCT07505771lastUpdatePostDate: changed
LOWJul 29, 2026NCT07505771lastUpdatePostDate: changed
LOWJul 29, 2026NCT07505771lastUpdatePostDate: changed
LOWJul 21, 2026NCT07505771startDate: changed
MEDIUMJul 17, 2026NCT07505771lastUpdatePostDate: changed
MEDIUMJul 17, 2026NCT07505771lastUpdatePostDate: changed

Frequently asked questions about 177Lu-IM-3050

What is 177Lu-IM-3050?

177Lu-IM-3050 is an investigational small molecule radiopharmaceutical being developed by Immunome, Inc. for the treatment of solid malignancies. It is currently in Phase 1 clinical development and has not been approved by the FDA. The compound is also known as 177Lu-3050.

What is 177Lu-IM-3050 used for?

177Lu-IM-3050 is being studied for use in patients with solid malignancies. It is an investigational therapy and is not approved for any indication. The Phase 1 trial enrolls adults with advanced cancer.

What does 177Lu-IM-3050 target?

177Lu-IM-3050 targets fibroblast activation protein, or FAP. It is a small molecule radiopharmaceutical that delivers the radioisotope lutetium-177 to FAP-expressing cells. FAP is a target of interest in solid tumor research.

Who is developing 177Lu-IM-3050?

177Lu-IM-3050 is being developed by Immunome, Inc., which trades on the Nasdaq under the ticker IMNM. Immunome is the sponsor of the Phase 1 clinical trial evaluating the compound in advanced cancer.

What phase is 177Lu-IM-3050 in?

177Lu-IM-3050 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 1 study is currently recruiting participants.

What clinical trials is 177Lu-IM-3050 in?

177Lu-IM-3050 is being evaluated in one Phase 1 clinical trial, NCT07505771, titled A Phase 1 Study of 177Lu-IM-3050 in Participants With Advanced Cancer. The trial is recruiting up to 105 adult participants in the United States.

Is 177Lu-IM-3050 the same as 177Lu-3050?

Yes, 177Lu-IM-3050 and 177Lu-3050 refer to the same investigational compound. 177Lu-3050 is an alternative name for the drug being developed by Immunome, Inc. for solid malignancies.