Recruiting
Early Phase 1

177Lu-IM-3050

Sponsor:

Immunome, Inc.

Code:

NCT07505771

Conditions

Solid Malignancies

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

177Lu-IM-3050

Study Details

Brief summary:

IM-3050-101 is a Phase 1 study to determine the safety and effectiveness of 177Lu-IM-3050 in treating participants with advanced cancer.

Conditions

Solid Malignancies

Study ID

NCT07505771

Start date

Jun 19, 2026

Status verified date

Jul, 2026

Completion date

Dec, 2034

Anticipated

Primary completion date

Dec, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 must be relapsed or refractory to, have developed an intolerance to, or not be candidates for available therapies with established benefit.
  • Participants must have measurable disease as per RECIST v.1.1 based on imaging performed during Screening.

  • During Part A only, participants without measurable disease per RECIST v1.1 are eligible if approved by Medical Monitor.
  • During screening, participants must have positive FAP PET/CT uptake as described in criteria for continuation of IM-3050 treatment.
  • Participants must have adequate organ function.

Exclusion Criteria:

  • Participant has received certain prior radiation therapy as detailed in the protocol
  • Participant has undergone major surgery within 4 weeks or minor surgery within 2 weeks of starting 177Lu-IM-3050 or has known active central nervous system (CNS) primary tumor or metastases and/or carcinomatous meningitis.
  • Participant has a known history of malignant primary brain tumor, or another primary solid or hematologic malignancy (other than that under study), unless the participant has undergone potentially curative therapy with no evidence of that disease for at least 2 years and approved by the Medical Monitor.

Exception: The time requirement does not apply to participants who underwent successful definitive resection of certain cancers.

  • Recent or ongoing serious infection or other significant medical condition as detailed in the protocol.
  • Participant has received an investigational product or been treated with an investigational device within 30 days, or 5 half-lives prior to receiving the FAP PET/CT imaging tracer or 177Lu-IM-3050.

Study Design

Enrollment

105 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose Escalation: 177Lu-IM-3050

177Lu-IM-3050 administered intravenously on a 6-week cycle

experimental: Dose Expansion: 177Lu-IM-3050

177Lu-IM-3050 administered intravenously on a 6-week cycle

Interventions

177Lu-IM-3050

177Lu-IM-3050 is a FAP-directed radiopharmaceutical

Primary outcome measure

  • Safety and tolerability of 177Lu-IM-3050 in participants with advanced solid tumors as measured by incidence of treatment emergent adverse events (TEAEs) [ Time Frame: From first dose of 177Lu-IM-3050 through at least 42 days following last dose of study treatment serious; up to approximately 5 years ]
  • Determine the recommended dose of 177Lu-IM-3050 for further development [ Time Frame: From first dose of 177Lu-IM-3050 to 42 days following last dose of study treatment; up to approximately 5 years ]

Central Contacts and Locations

Central contacts

Immunome Medical Monitor

425.939.7410info@immunome.com

Locations

Stanford University School of Medicine

Recruiting

Palo Alto, California, United States, 94305

University of Texas - MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Excel Diagnostics and Nuclear Oncology Center

Recruiting

Houston, Texas, United States, 77042

More Information

Sponsor

Immunome, Inc.

Last update posted

Jul 29, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Immunome, Inc. on 2026-07-29.