A Phase 1 Study of IM-1021 in Participants With Advanced Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorImmunome, Inc.
About this trial
IM-1021-101 is a Phase 1 study to determine the safety and effectiveness of IM-1021 in treating participants with advanced cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Informed consent signed by the participant prior to conducting study-specific procedures
≥18 years of age
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
Mantle cell lymphoma (MCL)
Disqualifiers
Previously treated with an ADC with a topoisomerase-1 inhibitor payload, except: Participants with triple negative breast cancer may have received up to one prior ADC with a topoisomerase-1 inhibitor payload.
Previously received a ROR1-targeted therapy (eg, ADC, cell therapy, or monoclonal antibody).
History of an anaphylactic reaction to irinotecan or ≥ grade 3 GI toxicity to prior irinotecan.
Life expectancy < 12 weeks.
Trial design
Design model
Sequential
Treatments tested in this trial
IM-1021
DrugIM-1021 is an antibody-drug conjugate
Treatment groups
190 Participants
are divided into 2 treatment groupsGroup A: Part A: IM-1021 Dose EscalationExperimental treatment 1 intervention
Group B: Part B: IM-1021 Monotherapy Dose ExpansionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 treatment2
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 treatmentSecondary outcomes
1
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 study2
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 study3
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 study4
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 studySponsors and contacts
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Source ClinicalTrials.gov