Actively Recruiting
A Phase 1 Study of IM-1021 in Participants With Advanced Cancer
Led by Immunome, Inc. · Updated on 2026-04-15
117
Participants Needed
13
Research Sites
205 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
IM-1021-101 is a Phase 1 study to determine the safety and effectiveness of IM-1021 in treating participants with advanced cancer.
CONDITIONS
Official Title
A Phase 1 Study of IM-1021 in Participants With Advanced Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent prior to study procedures
- At least 18 years old
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Histological or cytological diagnosis of advanced B-cell lymphomas (mantle cell lymphoma, diffuse large B-cell lymphoma including Richter's transformation, follicular lymphoma, small lymphocytic lymphoma) or advanced solid tumors (pancreatic cancer, non-squamous non-small cell lung cancer, malignant mesothelioma, epithelial ovarian cancer including fallopian tube and/or peritoneal malignancies, triple-negative breast cancer, liposarcoma) or other approved histologies
- For expansion cohorts, diagnosis of the specific disease indication
- Adequate organ function
- Negative pregnancy test and willingness to use highly effective birth control methods and refrain from oocyte/sperm donation
- Relapsed or refractory after at least one prior standard therapeutic regimen; B-cell malignancies require at least two prior lines of therapy, and small lymphocytic lymphoma requires at least three prior lines
- Measurable disease according to relevant response assessment criteria (Lugano Classification for lymphoma except SLL, iwCLL criteria for SLL, RECIST v.1.1 for solid tumors)
You will not qualify if you...
- Previous treatment with an antibody-drug conjugate containing a topoisomerase-1 inhibitor payload, except for up to one prior ADC in triple-negative breast cancer patients
- Prior receipt of ROR1-targeted therapy such as ADC, cell therapy, or monoclonal antibody
- History of anaphylactic reaction to irinotecan or severe gastrointestinal toxicity (grade 3 or higher) to irinotecan
- Life expectancy less than 12 weeks
- Prior solid organ transplant
- Symptomatic ascites or pleural effusion unless clinically stable for at least 2 weeks after treatment
- Known active central nervous system primary tumor, metastases, or carcinomatous meningitis unless stable brain metastases for at least 4 weeks, no new lesions, and stable or no steroids
- History of malignant primary brain tumor or other primary malignancy unless disease-free for at least 2 years or successfully resected
- Significant cardiac, pulmonary, or infectious disease as detailed in the protocol
- Pregnancy, breastfeeding, or planning to conceive during the study
AI-Screening
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Trial Site Locations
Total: 13 locations
1
City Of Hope
Duarte, California, United States, 91010
Actively Recruiting
2
Colorado Blood Cancer Institute
Denver, Colorado, United States, 80218
Actively Recruiting
3
Yale University Medical Center
New Haven, Connecticut, United States, 06510
Actively Recruiting
4
Emory Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
5
Norton Healthcare
Louisville, Kentucky, United States, 40202
Actively Recruiting
6
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
7
START Midwest
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
8
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68105
Actively Recruiting
9
Gabrail Cancer Center
Canton, Ohio, United States, 44718
Actively Recruiting
10
Sarah Cannon Research Institute - Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
11
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
12
NEXT Oncology
Irving, Texas, United States, 75039
Actively Recruiting
13
START - Fundacion Jimenez Diaz
Madrid, Spain, 28040
Actively Recruiting
Research Team
I
Immunome Medical Monitor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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