Actively Recruiting
A Phase 1 Study of IM-1021 in Participants With Advanced Malignancies
Led by Immunome, Inc. · Updated on 2026-04-15
117
Participants Needed
13
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating IM-1021, an antibody-drug conjugate, in participants with advanced cancers including B-cell lymphomas and solid tumors. This Phase 1 open-label study aims to assess the safety, tolerability, pharmacokinetics, and early anti-tumor effects of IM-1021. The study includes a dose escalation phase to find safe doses and schedules, followed by an expansion phase to further assess these doses in specific cancer types. IM-1021 is given intravenously on a 21-day cycle, starting at 2 mg/kg, with alternative dosing schedules possible. The study has two parts: Part A focuses on escalating doses to evaluate safety and determine recommended doses, while Part B expands treatment in groups with specific cancer types to further evaluate safety and preliminary activity. Participants will undergo regular safety assessments including monitoring for treatment-related side effects from the first dose through 37 days after the last dose. Researchers will also measure drug levels in the body and evaluate anti-tumor activity starting at week 6 until disease progression or study discontinuation. The total study duration varies per participant. Safety, tolerability, and pharmacokinetic data will guide future development of IM-1021.
CONDITIONS
Brief 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 before study procedures
- 18 years of age or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Diagnosed with advanced B-cell lymphomas (mantle cell lymphoma, diffuse large B-cell lymphoma including Richter's transformation, follicular lymphoma, small lymphocytic lymphoma) or solid tumors (pancreatic cancer, non-squamous non-small cell lung cancer, malignant mesothelioma, epithelial ovarian cancer including fallopian tube or peritoneal malignancies, triple-negative breast cancer, liposarcoma) or other histologies approved by the Sponsor Medical Monitor
- Adequate organ function
- Negative pregnancy test and willing to use highly effective birth control and refrain from oocyte/sperm donation as applicable
- Refractory to or relapsed after at least one prior standard therapy; B-cell malignancies require at least two prior therapies, and small lymphocytic lymphoma requires at least three prior therapies
- Measurable disease according to relevant criteria (Lugano Classification, iwCLL, RECIST v1.1)
You will not qualify if you...
- Previously treated with an antibody-drug conjugate with a topoisomerase-1 inhibitor payload, except for one prior ADC in triple negative breast cancer
- Previously received ROR1-targeted therapy
- History of anaphylaxis to irinotecan or severe gastrointestinal toxicity from prior 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
- Active central nervous system primary tumor, metastases, or carcinomatous meningitis unless clinically stable brain metastases for at least 4 weeks and off steroids or on stable low dose
- History of malignant primary brain tumor or other malignancy unless disease-free for at least 2 years or certain cancers resected successfully
- Significant cardiac, pulmonary, or infectious diseases as detailed in the protocol
- Pregnant, breastfeeding, or expecting to conceive during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 21-day cycles until disease progression or discontinuation
Participants receive IM-1021 intravenously on a 21-day cycle to evaluate safety, tolerability, and preliminary anti-tumor activity.
Visits every 3 weeks for each treatment cycle
Duration - Up to 37 days following last dose
Participants are monitored for safety and treatment effects for up to 37 days following the last dose of IM-1021.
Approximately 1 to 2 follow-up visits
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
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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