Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2026-01-20 @ 10:06 PM
Study NCT ID:
NCT06823167
Status:
RECRUITING
Last Update Posted:
2025-10-24
First Post:
2025-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 1 Study of IM-1021 in Participants With Advanced Cancer
Sponsor:
Immunome, Inc.
Organization:
Study Overview
Official Title:
A Phase 1 Study of IM-1021 in Participants With Advanced Malignancies
Status:
RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: