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

August 5, 2026 updated by: Immunome, Inc.

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
190

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Denmark
      • Copenhagen, Denmark, DK-2100
        • Recruiting
        • Copenhagen University Hospital
  • France
      • Lyon, France, 69008
        • Recruiting
        • Centre Leon-Berard
      • Paris, France, 75005
        • Recruiting
        • LITO, Institut Curie Hospital Gropu
      • Villejuif, France, 94805
        • Recruiting
        • Gustave Roussy
  • Spain
  • United States
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope
        • Contact:
          • Matthew Mei, MD
          • Phone Number: 626-218-7457
          • Email: mamei@coh.org
      • Los Angeles, California, United States, 90095
        • Recruiting
        • University of California
    • Colorado
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Yale University Medical Center
        • Contact:
    • Florida
      • Tampa, Florida, United States, 33606
        • Recruiting
        • Tampa General Hospital
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory Winship Cancer Institute
        • Contact:
        • Contact:
          • Emma Barton-Judson
          • Phone Number: 404-778-2695
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • Norton Cancer Institute
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan
        • Contact:
      • Grand Rapids, Michigan, United States, 49546
        • Recruiting
        • Start Midwest
        • Contact:
          • Abigail VanKirk, Site Coordinator
          • Phone Number: 616-389-1824
    • Nebraska
      • Omaha, Nebraska, United States, 68105
        • Recruiting
        • University of Nebraska Medical Center
        • Contact:
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Recruiting
        • Levine Cancer Institute
    • Ohio
      • Canton, Ohio, United States, 44718
        • Recruiting
        • Gabrail Cancer Center
        • Contact:
        • Contact:
          • Kim Roby
          • Phone Number: 330-492-3345
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Recruiting
        • Brown University
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Sarah Cannon Research Institute - Oncology Partners
        • Contact:
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • MD Anderson Cancer Center
        • Contact:
      • Irving, Texas, United States, 75039
        • Recruiting
        • Next Oncology
        • Contact:
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • UT San Antonio Mays Cancer
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Recruiting
        • University of Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)
    • Marginal zone lymphoma

    Solid Tumors:

    • Pancreatic cancer
    • Non-squamous non-small cell lung cancer (NSCLC)
    • Malignant mesothelioma
    • Epithelial ovarian cancer. Participants with fallopian tube and/or peritoneal malignancies are also eligible.
    • Triple-negative breast cancer.
    • Liposarcoma

    Other, unlisted histologies, if approved by the Sponsor Medical Monitor

    Part B Cohorts B1, B2, and B3:

    Histological or cytological diagnosis of the cohort-specific disease indication. Indications may include those listed in Inclusion Criterion 4.a

  5. Participants must have adequate organ function.
  6. Participants must have a negative pregnancy test, be willing to practice highly effective methods of birth control, use condoms, and refrain from oocyte/sperm donation, as applicable, as detailed in the protocol.
  7. Participants must have relapsed or refractory disease and have received all approved and available therapeutic options.
  8. Participants must have measurable disease as per the relevant response assessment framework: Lugano Classification for lymphoma (except SLL), per iwCLL criteria for SLL , and per RECIST v.1.1 for solid tumors.

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. For participants with known active central nervous system (CNS) disease

    1. For participants with solid tumors: Participant has a known active 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.
    2. For participants with lymphoma: Participant has active cerebral/meningeal disease related to the underlying malignancy. Participants with a history of cerebral/meningeal disease related to the underlying malignancy are allowed if prior CNS disease has been effectively treated and without progression for at least 3 months.
  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part A: IM-1021 Dose Escalation
IM-1021 given into the vein (IV; intravenously)
Drug: IM-1021
IM-1021 is an antibody-drug conjugate
Experimental: Part B: IM-1021 Monotherapy Dose Expansion
IM-1021 given into the vein (IV; intravenously)
Drug: IM-1021
IM-1021 is an antibody-drug conjugate

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Time Frame: From first dose to 37 days following last dose of study treatment
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
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
Time Frame: From first dose to 37 days following last dose of study treatment
Type, frequency, seriousness, and severity of AEs graded using the NCI-CTCAE v6.0, including SAEs, AEIs, AEs leading to discontinuation, and deaths
From first dose to 37 days following last dose of study treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Pharmacokinetic (PK) parameter
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
Determined by the incidence of anti-drug antibodies (ADA) to IM-1021 from pre-infusion sample prior to each cycle.
From first dose to about 30 days following last dose of study treatment
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
PK parameter
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
PK parameter
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
PK parameter
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
PK parameter
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
PK parameter
Through 30-37 days following last dose of IM-1021 up to end of 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
Objective response rate (ORR) as measured by Lugano Classification for participants with lymphoma (except small lymphocytic lymphoma [SLL]), per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria for participants with SLL, and per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 for participants with solid tumors
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
Complete response rate (CRR) as measured by Lugano Classification for participants with lymphoma (except SLL), per iwCLL criteria for participants with SLL, and per RECIST v.1.1 for participants with solid tumors
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
Disease control rate (DCR) as measured by Lugano Classification for participants with lymphoma (except SLL), per iwCLL criteria for participants with SLL, and per RECIST v.1.1 for participants with solid tumors
Week 6 until disease progression or participant discontinuation from study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Immunome, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 26, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 4, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 12, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IM-1021-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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