Recent Updates
Recently added Catalysts

177Lu-3050

Phase 1

Solid Malignancies | Small molecule | Oncology |Immunome, Inc.|Last Updated: Jul 29, 2026

Target and mechanism

ModalitySmall molecule

Also known as 177Lu-IM-3050

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

CONTROLLED
Total Trials1
Total Enrollment105

FDA Designations

No designations recorded

Clinical trial landscape

177Lu-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
Unlock Study Endpoints

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
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

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
Unlock Eligibility Criteria

Recent Changes (Last 90 Days)

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-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 Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities. The drug is being studied in patients with advanced cancer to evaluate its safety and efficacy.

What does 177Lu-3050 target?

The specific molecular target of 177Lu-3050 has not been disclosed. As a small molecule, it is designed to interact with cellular components involved in cancer growth, but the exact target is not publicly available. The drug is being studied in solid malignancies, where it may act on pathways relevant to tumor progression.

Who makes 177Lu-3050?

177Lu-3050 is being developed by Immunome, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol IMNM. The company is conducting clinical trials to evaluate the drug's potential in treating advanced solid tumors. Immunome is responsible for the drug's development and regulatory strategy.

What phase is 177Lu-3050 in?

177Lu-3050 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or any other regulatory body. The ongoing Phase 1 trial is designed to assess the drug's safety, tolerability, and preliminary efficacy in patients with advanced solid malignancies.

What clinical trials is 177Lu-3050 in?

177Lu-3050 is being studied in a single Phase 1 clinical trial with the identifier NCT07505771. This trial, titled 'A Phase 1 Study of 177Lu-IM-3050 in Participants With Advanced Cancer,' is currently recruiting participants in the United States. The study aims to enroll 105 patients aged 18 years and older with solid malignancies.

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. The alternative name is used in clinical trial documentation, such as the Phase 1 study NCT07505771, which is evaluating the drug in patients with advanced solid tumors.