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A Phase 1 Study of IM-1021 in Participants With Advanced Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

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

NCT06823167•Immunome, Inc.

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Informed consent signed by the participant prior to conducting study-specific procedures
•2. ≥18 years of age
•3. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
•4. Histological or cytological diagnosis of:
•Part A: advanced B-cell lymphomas or solid tumors, of the following subtypes:
•B-cell Lymphomas:
•* Mantle cell lymphoma (MCL)
•* Diffuse large B-cell lymphoma (DLBCL) (including Richter's transformation)
•* Follicular lymphoma
•* Small lymphocytic lymphoma (SLL)
+14 more criteria

Exclusion Criteria

•1. 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.
•2. Previously received a ROR1-targeted therapy (eg, ADC, cell therapy, or monoclonal antibody).
•3. History of an anaphylactic reaction to irinotecan or ≥ grade 3 GI toxicity to prior irinotecan.
•4. Life expectancy \< 12 weeks.
•5. Prior solid organ transplant.
•6. Participants with symptomatic ascites or pleural effusion. Participants who are clinically stable for at least 2 weeks following treatment for these conditions (including therapeutic thoraco- or paracentesis or catheter) are eligible.
•7. Participant has a known active central nervous system (CNS) primary tumor or metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks prior to study entry, have no radiological evidence of new or enlarging brain metastases, and are off steroids or on a stable dose up to an equivalent of prednisone 10 mg/day for at least 15 days prior to first dose of study medication. Participants who have symptoms consistent with CNS metastasis must have a negative magnetic resonance imaging (MRI) or other clinically appropriate imaging study if the participant is not able to undergo contrast-enhanced MRI and approved by the Sponsor Medical Monitor during the screening period.
•8. Participant has a known history of malignant primary brain tumor, or another primary solid or hematologic malignancy (other than that under study), unless the participant has undergone potentially curative therapy with no evidence of that disease for at least 2 years. Exception: The time requirement does not apply to participants who underwent successful definitive resection of certain cancers.
•9. Participant has certain other significant medical conditions including cardiac, pulmonary, and infectious disease as detailed in the protocol.
•10. Participant is pregnant, breastfeeding, or expecting to conceive within the projected duration of the study.

Locations (10)

City Of Hope

Duarte, California, United States

Yale University Medical Center

New Haven, Connecticut, United States

Emory Winship Cancer Institute

Atlanta, Georgia, United States

University of Michigan

Ann Arbor, Michigan, United States

START Midwest

Grand Rapids, Michigan, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Gabrail Cancer Center

Canton, Ohio, United States

Sarah Cannon Research Institute - Oncology Partners

Nashville, Tennessee, United States

MD Anderson Cancer Center

Houston, Texas, United States

NEXT Oncology

Irving, Texas, United States

Key Dates

Start Date

February 26, 2025

Primary Completion Date

May 1, 2028

Completion Date

February 1, 2029

Last Updated

February 19, 2026

Enrollment

117

ESTIMATED participants

Conditions

Solid MalignanciesHematologic Malignancies

Interventions

IM-1021

BIOLOGICAL

Contacts

Immunome Medical Monitor

CONTACT

425.939.7410 info@immunome.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 19, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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