A Phase 1 Study of IM-1021 in Participants With Advanced Malignancies
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.
Arms & interventions
- BiologicalIM-1021
IM-1021 is an antibody-drug conjugate
Outcome measures
Primary
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 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
Secondary
Area under the concentration-time curve (AUC) of IM-1021 in participants with advanced lymphomas and advanced solid tumors
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
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
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
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
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
Time frame: Through 30-37 days following last dose of IM-1021 up to end of study
Characterize the immunogenicity of IM-1021
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
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
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
Time frame: Week 6 until disease progression or participant discontinuation from study
Eligibility criteria
Study locations (12)
City Of Hope
Duarte, California, 91010
Colorado Blood Cancer Institute
Denver, Colorado, 80218
Yale University Medical Center
New Haven, Connecticut, 06510
Emory Winship Cancer Institute
Atlanta, Georgia, 30322
Norton Healthcare
Louisville, Kentucky, 40202
University of Michigan
Ann Arbor, Michigan, 48109
START Midwest
Grand Rapids, Michigan, 49546
University of Nebraska Medical Center
Omaha, Nebraska, 68105
Gabrail Cancer Center
Canton, Ohio, 44718
Sarah Cannon Research Institute - Oncology Partners
Nashville, Tennessee, 37203
MD Anderson Cancer Center
Houston, Texas, 77030
NEXT Oncology
Irving, Texas, 75039