A Phase 1 Study of IM-1021 in Participants With Advanced Malignancies
Immunome, Inc.
Summary
IM-1021-101 is a Phase 1 study to determine the safety and effectiveness of IM-1021 in treating participants with advanced cancer.
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Informed consent signed by the participant prior to conducting study-specific procedures 2. ≥18 years of age 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 4. Histological or cytological diagnosis of: Part A: advanced B-cell lymphomas or solid tumors, of the following subtypes: B-cell Lymphomas: * Mantle cell lymphoma (MCL) * Diffuse large B-cell lymphoma (DLBCL) (including Richter's transformation) * Follicular lymphoma * Small lymphocytic lymphoma (SLL) Solid Tumors: * Pancreatic cancer * Non-squamous non-sm…
Interventions
- BiologicalIM-1021
IM-1021 is an antibody-drug conjugate
Locations (13)
- City Of HopeDuarte, California
- Colorado Blood Cancer InstituteDenver, Colorado
- Yale University Medical CenterNew Haven, Connecticut
- Emory Winship Cancer InstituteAtlanta, Georgia
- Norton HealthcareLouisville, Kentucky
- University of MichiganAnn Arbor, Michigan