NCT06823167

A Phase 1 Study of IM-1021 in Participants With Advanced Cancer

A Phase 1 Study of IM-1021 in Participants With Advanced Malignancies

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 117 (estimated)
• Sponsor: Immunome, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

IM-1021-101 is a Phase 1 study to determine the safety and effectiveness of IM-1021 in treating participants with advanced cancer.

Detailed description

IM-1021-101 is a 2-part Phase 1 first-in-human (FIH), open-label, multicenter dose escalation and expansion study designed to determine the safety, tolerability, pharmacokinetics (PK), and preliminary anti-tumor activity of the ROR1 directed antibody-drug conjugate (ADC) IM-1021. IM-1021 will be administered to participants with advanced B-cell lymphomas and advanced solid tumors. Part A of the study is a dose escalation phase to evaluate safety and tolerability of IM-1021 and to determine recommended doses for further development. IM-1021 will be administered intravenously on an intermittent basis. The safety and tolerability of escalating doses of IM-1021 will be evaluated. Alternative dosing schedules may also be evaluated. Part B of the study is an expansion phase to further evaluate safety and tolerability of IM-1021 at candidate recommended doses in indication specific cohorts of participants. The safety and preliminary efficacy endpoints of this study will inform a preliminary risk-benefit assessment of IM-1021 in this patient population.

Conditions

• Solid Malignancies
• Hematologic Malignancies

Interventions

Type	Name	Description
BIOLOGICAL	IM-1021	IM-1021 is an antibody-drug conjugate

Timeline

• Start date: 2025-02-26
• Primary completion: 2028-05-01
• Completion: 2029-02-01
• First posted: 2025-02-12
• Last updated: 2026-04-15

Locations

13 sites across 2 countries: United States, Spain

Regulatory

• FDA-regulated drug study