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177Lu-IM-3050

Phase 1

Solid Malignancies | Small molecule | Oncology |Immunome, Inc.|Last Updated: Sep 8, 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

Early Phase 1 1
NCT07505771A Phase 1 Study of 177Lu-IM-3050 in Participants With Advanced CancerSolid Malignancies
RECRUITING105 Analytics
EARLY_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 Sites4

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)

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
LOWJun 18, 2026NCT07505771startDate: changed
LOWJun 18, 2026NCT07505771startDate: changed
LOWJun 18, 2026NCT07505771startDate: changed

Frequently asked questions about 177Lu-IM-3050

What is 177Lu-3050 used for?

177Lu-3050 is an investigational small molecule being developed for the treatment of solid malignancies. It is currently in early clinical development, with a Phase 1 study evaluating its safety and efficacy in participants with advanced cancer. The drug is not yet approved by regulatory authorities.

What does 177Lu-3050 target?

177Lu-3050 targets fibroblast activation protein (FAP), a protein often overexpressed in the tumor microenvironment of solid tumors. By binding to FAP, the drug aims to deliver a therapeutic radioactive payload directly to cancer cells, potentially limiting damage to healthy tissues.

Who is developing 177Lu-3050?

177Lu-3050 is being developed by Immunome, Inc., a biopharmaceutical company listed on the NASDAQ under the ticker symbol IMNM. The company is conducting clinical trials to evaluate the drug's potential in treating advanced solid malignancies.

What phase is 177Lu-3050 in?

177Lu-3050 is in Phase 1 clinical development. The drug is investigational and has not received regulatory approval. A Phase 1 study is currently recruiting participants to assess its safety, tolerability, and preliminary efficacy in patients with advanced cancer.

What clinical trials is 177Lu-3050 in?

177Lu-3050 is being studied in a Phase 1 clinical trial with the identifier NCT07505771, titled 'A Phase 1 Study of 177Lu-IM-3050 in Participants With Advanced Cancer.' This trial is recruiting 105 participants with solid malignancies in the United States, with a minimum age of 18 years.

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

Yes, 177Lu-3050 is also known as 177Lu-IM-3050. Both names refer to the same investigational drug being developed by Immunome, Inc. for the treatment of solid malignancies.