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New Antibody-Drug conjugate enters human trials for advanced cancers

NCT ID NCT06823167

Disease control Sponsor: Immunome, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 11, 2026 · Updated 6 times

Summary

This early-stage trial tests IM-1021, an antibody-drug conjugate designed to deliver a cancer-killing drug directly to tumor cells. It enrolls 117 adults with advanced solid tumors or B-cell lymphomas that have not responded to standard treatments. The main goals are to check safety and find the right dose for future studies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
IM-1021 (an antibody-drug conjugate)
What this could lead to
If successful, this could point toward a new treatment option for people with advanced cancers that have not responded to other therapies.
What could go wrong
This is an early Phase 1 trial with only 117 participants, so the main goal is safety and dosing—not yet proving effectiveness. Side effects are unknown and could be serious.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 190 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Feb 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

B-cell chronic lymphocytic leukemia cancer diffuse large B-cell lymphoma follicular lymphoma hematopoietic and lymphoid system neoplasm liposarcoma malignant mesothelioma malignant pancreatic neoplasm mantle cell lymphoma marginal zone lymphoma non-small cell lung carcinoma ovarian carcinoma triple-negative breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hematologic malignancies Solid malignancies

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    24 sites in 4 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Brown University

    RECRUITING

    Providence, Rhode Island, 02903, United States

  • Centre Leon-Berard

    RECRUITING

    Lyon, 69008, France

  • City Of Hope

    RECRUITING

    Duarte, California, 91010, United States

  • Colorado Blood Cancer Institute

    RECRUITING

    Denver, Colorado, 80218, United States

  • Copenhagen University Hospital

    RECRUITING

    Copenhagen, DK-2100, Denmark

  • Emory Winship Cancer Institute

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Gabrail Cancer Center

    RECRUITING

    Canton, Ohio, 44718, United States

  • Gustave Roussy

    RECRUITING

    Villejuif, 94805, France

  • LITO, Institut Curie Hospital Gropu

    RECRUITING

    Paris, 75005, France

  • Levine Cancer Institute

    RECRUITING

    Charlotte, North Carolina, 28204, United States

  • MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • NEXT Oncology

    RECRUITING

    Irving, Texas, 75039, United States

  • Norton Cancer Institute

    RECRUITING

    Louisville, Kentucky, 40202, United States

  • START - Fundacion Jimenez Diaz

    RECRUITING

    Madrid, 28040, Spain

  • START Midwest

    RECRUITING

    Grand Rapids, Michigan, 49546, United States

  • Sarah Cannon Research Institute - Oncology Partners

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Tampa General Hospital

    RECRUITING

    Tampa, Florida, 33606, United States

  • UT San Antonio Mays Cancer

    RECRUITING

    San Antonio, Texas, 78229, United States

  • University of California

    RECRUITING

    Los Angeles, California, 90095, United States

  • University of Iowa

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of Nebraska Medical Center

    RECRUITING

    Omaha, Nebraska, 68105, United States

  • University of Virginia

    RECRUITING

    Charlottesville, Virginia, 22903, United States

  • Yale University Medical Center

    RECRUITING

    New Haven, Connecticut, 06510, United States

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