A Phase 1 Study of IM-1021 in Participants With Advanced Cancer
NCT ID: NCT06823167
Last Updated: 2026-01-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1
117 participants
INTERVENTIONAL
2025-02-26
2029-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety and Efficacy Study of IMSA101 in Refractory Malignancies
NCT04020185
A Rollover Study for Subjects Who Completed Participation in IMSA101-101 Trial
NCT06026254
A Study of IMC-001 In Patients With Metastatic Or Locally Advanced TMB-H Solid Tumor
NCT06365840
A Study of IMC-002 in Patients With Advanced Cancer Failed to Standard Therapy
NCT05276310
A Study to Evaluate MEDI0562 in Combination With Immune Therapeutic Agents in Adult Subjects With Advanced Solid Tumors
NCT02705482
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment Arm
IM-1021 administered intravenously on a 21-day cycle, at a starting dose of 2 mg/kg.
IM-1021
IM-1021 is an antibody-drug conjugate
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
IM-1021
IM-1021 is an antibody-drug conjugate
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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)
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 be refractory to or have relapsed after at least one prior standard therapeutic regimen. Participants must be relapsed or refractory to, have developed an intolerance to, or not be candidates for available therapies with established benefit. Participants with B-cell malignancies should have received at least two lines of therapy, including available therapies with established benefit. Participants with SLL should have received at least three prior lines of therapy.
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
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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Immunome, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
City Of Hope
Duarte, California, United States
Yale University Medical Center
New Haven, Connecticut, 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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Abigail VanKirk, Site Coordinator
Role: primary
Kim Roby
Role: backup
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IM-1021-101
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.