BOTHELL, Wash., July 20, 2026
Immunome, Inc. (Nasdaq: IMNM) announced that the first patient has been dosed in the Phase 1 first-in-human clinical trial evaluating IM-3050, an investigational fibroblast activation protein (FAP)-targeted radioligand therapy (RLT) for patients with FAP-expressing advanced solid tumors. The milestone marks the clinical debut of Immunome’s novel radioligand therapy platform, which is designed to deliver radioactive lutetium-177 directly to FAP-expressing cells within the tumor microenvironment. By targeting one of the most widely expressed proteins in solid tumors, IM-3050 has the potential to expand the application of targeted radiopharmaceutical therapies across multiple cancer types. The Phase 1 study will evaluate the therapy’s safety, tolerability, dosimetry, pharmacokinetics, and preliminary anti-tumor activity, laying the foundation for future clinical development.
IM-3050 Targets FAP-Expressing Cells with Lutetium-177
IM-3050 is an investigational lutetium-177 radioligand therapy engineered to target fibroblast activation protein (FAP), a protein highly expressed on cancer-associated fibroblasts within the tumor microenvironment and found in approximately 75% of solid tumors. After binding to FAP-expressing cells, IM-3050 delivers radioactive lutetium-177, which emits beta particles capable of damaging targeted cells while also destroying nearby tumor cells through a bystander effect. This targeted radiation approach aims to maximize anti-cancer activity while minimizing exposure to healthy tissues. According to Immunome, the widespread expression of FAP across numerous solid tumor types makes it an attractive therapeutic target and positions IM-3050 as a potentially broad-spectrum radioligand therapy for difficult-to-treat cancers.
Phase 1 Trial Designed to Evaluate Safety and Early Clinical Activity
The ongoing Phase 1 study is an open-label, multicenter dose-escalation and expansion trial enrolling patients with FAP-expressing advanced solid tumors. During the dose-escalation phase, participants will receive repeated escalating doses of IM-3050 to determine the maximum tolerated dose (MTD) and identify the recommended expansion dose (RED). Following dose selection, the expansion portion of the study will further evaluate safety, tolerability, pharmacokinetics, radiation dosimetry, and preliminary anti-tumor efficacy at the selected dose level. The trial is designed to establish the clinical profile of IM-3050 while providing early evidence of therapeutic activity that may support future development in multiple solid tumor indications.
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IM-3050 Expands Immunome’s Targeted Oncology Pipeline
The initiation of the IM-3050 clinical program further strengthens Immunome’s targeted oncology portfolio, which focuses on developing first-in-class and best-in-class cancer therapies using precision targeting technologies. In addition to IM-3050, the company’s pipeline includes varegacestat, an investigational gamma secretase inhibitor currently under FDA NDA review, IM-1021, a clinical-stage ROR1 antibody-drug conjugate (ADC), IM-1617, a clinical-stage solid tumor ADC, and several early-stage ADC programs targeting undisclosed solid tumor antigens. By expanding into targeted radioligand therapy, Immunome aims to complement its antibody-drug conjugate expertise while advancing innovative treatment options for patients with advanced cancers that currently have limited therapeutic alternatives. The first patient dosed represents an important milestone as the company continues building a diversified pipeline of precision oncology therapies.
Source: Immunome press release
