A Phase 1 interventional study of IM-1021 in Solid Malignancies and Hematologic Malignancies, sponsored by Immunome, Inc.. Recruiting at 24 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-10.
Sponsored by Immunome, Inc. · Phase 1, Interventional, and Treatment
IM-1021-101 is a Phase 1 study to determine the safety and effectiveness of IM-1021 in treating participants with advanced cancer.
IM-1021-101 is a 2-part Phase 1 first-in-human, 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.
Histological or cytological diagnosis of:
Part A: advanced B-cell lymphomas or solid tumors, of the following subtypes:
B-cell Lymphomas:
Solid Tumors:
Other, unlisted histologies, if approved by the Sponsor Medical Monitor
Part B Cohorts B1, B2, and B3:
Histological or cytological diagnosis of the cohort-specific disease indication. Indications may include those listed in Inclusion Criterion 4.a
Exclusion Criteria:
For participants with known active central nervous system (CNS) disease
IM-1021 given into the vein (IV; intravenously)
Drug: IM-1021
IM-1021 given into the vein (IV; intravenously)
Drug: IM-1021
IM-1021 is an antibody-drug conjugate
Safety and tolerability of IM-1021 in participants with advanced lymphomas and advanced solid tumors as measured by incidence of treatment emergent adverse events (TEAEs)
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 5.0, including serious adverse events (SAEs), AEs of interest (AEI), AEs leading to discontinuation, and deaths
Time frame: From first dose to 37 days following last dose of study treatment
Determine the recommended dose(s) and schedule(s) of IM-1021 for further development
Type, frequency, seriousness, and severity of AEs graded using the NCI-CTCAE v6.0, including SAEs, AEIs, AEs leading to discontinuation, and deaths
Time frame: From first dose to 37 days following last dose of study treatment
Area under the concentration-time curve (AUC) of IM-1021 in participants with advanced lymphomas and advanced solid tumors
Pharmacokinetic (PK) parameter
Time frame: Through 30-37 days following last dose of IM-1021 up to end of study
Concentration at end of infusion (Ceoi) of IM-1021 in participants with advanced lymphomas and advanced solid tumors
PK parameter
Time frame: Through 30-37 days following last dose of IM-1021 up to end of study
Maximum observed concentration (Cmax) of IM-1021 in participants with advanced lymphomas and advanced solid tumors
PK parameter
Time frame: Through 30-37 days following last dose of IM-1021 up to end of study
Time to maximum observed concentration (Tmax) of IM-1021 in participants with advanced lymphomas and advanced solid tumors
PK parameter
Time frame: Through 30-37 days following last dose of IM-1021 up to end of study
Trough Concentration of IM-1021 in participants with advanced lymphomas and advanced solid tumors
PK parameter
Time frame: Through 30-37 days following last dose of IM-1021 up to end of study
Apparent Terminal Half-Life (t1/2) of IM-1021 in participants with advanced lymphomas and advanced solid tumors
PK parameter
Time frame: Through 30-37 days following last dose of IM-1021 up to end of study
Characterize the immunogenicity of IM-1021
Determined by the incidence of anti-drug antibodies (ADA) to IM-1021 from pre-infusion sample prior to each cycle.
Time frame: From first dose to about 30 days following last dose of study treatment
To evaluate the preliminary anti-tumor activity of IM-1021 in participants with advanced lymphomas and advanced solid tumors
Objective response rate (ORR) as measured by Lugano Classification for participants with lymphoma (except small lymphocytic lymphoma \[SLL\]), per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria for participants with SLL, and per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 for participants with solid tumors
Time frame: Week 6 until disease progression or participant discontinuation from study
To evaluate the preliminary anti-tumor activity of IM-1021 in participants with advanced lymphomas and advanced solid tumors
Complete response rate (CRR) as measured by Lugano Classification for participants with lymphoma (except SLL), per iwCLL criteria for participants with SLL, and per RECIST v.1.1 for participants with solid tumors
Time frame: Week 6 until disease progression or participant discontinuation from study
To evaluate the preliminary anti-tumor activity of IM-1021 in participants with advanced lymphomas and advanced solid tumors
Disease control rate (DCR) as measured by Lugano Classification for participants with lymphoma (except SLL), per iwCLL criteria for participants with SLL, and per RECIST v.1.1 for participants with solid tumors
Time frame: Week 6 until disease progression or participant discontinuation from study
Plan to share: Undecided
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Immunome, Inc.