A Phase 1 Study of IM-1021 in Participants With Advanced Cancer

Active:	Yes
Cancer Type:	Cancer-Related Syndrome Gynecologic Cancers Ovarian Cancer Primary Peritoneal Cancer Sarcoma	NCT ID:	NCT06823167
Trial Phases:	Phase I	Protocol IDs:	IM-1021-101 (primary) NCI-2025-03470
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Immunome, Inc.
NCI Full Details:	http://clinicaltrials.gov/show/NCT06823167

Summary

IM-1021-101 is a Phase 1 study to determine the safety and effectiveness of IM-1021 in
treating participants with advanced cancer.

Objectives

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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.