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

NCT06823167 | Recruiting Phase 1 FDA Drug

• 1 other identifier: IM-1021-101
• Study Type: interventional
• Target: 117
• Locations: 2 countries
• Sites: 13

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.

Conditions

Solid Malignancies; Hematologic Malignancies

Outcome Measures

Primary Outcomes (2)

• 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)

  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

  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

Secondary Outcomes (10)

• Area under the concentration-time curve (AUC) of IM-1021 in participants with advanced lymphomas and advanced solid tumors

  Through 30-37 days following last dose of IM-1021 up to end of study

• Concentration at end of infusion (Ceoi) of IM-1021 in participants with advanced lymphomas and advanced solid tumors

  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

  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

  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

  Through 30-37 days following last dose of IM-1021 up to end of study

Study Arms (1)

Treatment Arm

EXPERIMENTAL

IM-1021 administered intravenously on a 21-day cycle, at a starting dose of 2 mg/kg.

Biological: IM-1021

Interventions

IM-1021 BIOLOGICAL

IM-1021 is an antibody-drug conjugate

Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent signed by the participant prior to conducting study-specific procedures
• ≥18 years of age
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
• 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)
• 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.

You may not qualify if:

• 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.
• Previously received a ROR1-targeted therapy (eg, ADC, cell therapy, or monoclonal antibody).
• History of an anaphylactic reaction to irinotecan or ≥ grade 3 GI toxicity to prior irinotecan.
• Life expectancy \< 12 weeks.
• Prior solid organ transplant.
• 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.
• 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.
• 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.
• Participant has certain other significant medical conditions including cardiac, pulmonary, and infectious disease as detailed in the protocol.
• Participant is pregnant, breastfeeding, or expecting to conceive within the projected duration of the study.

Sponsors & Collaborators

• Immunome, Inc.: lead

Study Sites (13)

City Of Hope

Duarte, California, 91010, United States

RECRUITING

Colorado Blood Cancer Institute

Denver, Colorado, 80218, United States

RECRUITING

Yale University Medical Center

New Haven, Connecticut, 06510, United States

RECRUITING

Emory Winship Cancer Institute

Atlanta, Georgia, 30322, United States

RECRUITING

Norton Healthcare

Louisville, Kentucky, 40202, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

START Midwest

Grand Rapids, Michigan, 49546, United States

RECRUITING

University of Nebraska Medical Center

Omaha, Nebraska, 68105, United States

RECRUITING

Gabrail Cancer Center

Canton, Ohio, 44718, United States

RECRUITING

Sarah Cannon Research Institute - Oncology Partners

Nashville, Tennessee, 37203, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

NEXT Oncology

Irving, Texas, 75039, United States

RECRUITING

START - Fundacion Jimenez Diaz

Madrid, 28040, Spain

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Immunome Medical Monitor

CONTACT

425.939.7410; info@immunome.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: February 12, 2025
• Study Start: February 26, 2025
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): February 1, 2029
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

ES (1); US (12)