Actively Recruiting
Phase 1 Study Evaluating Safety and Activity of IM-1021 in Adults with Advanced B-cell Lymphomas and Solid Tumors
Led by Immunome, Inc. · Updated on 2026-08-10
190
Participants Needed
24
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 a Phase 1 study involving participants with advanced B-cell lymphomas and solid tumors. This first-in-human, open-label study aims to assess the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of IM-1021. The study includes a dose escalation phase to find safe and tolerable doses and an expansion phase to further evaluate these doses in specific cancer types. The study has two parts Part A focuses on escalating doses of IM-1021 given intravenously to determine safety and recommended dosing schedules, including the possibility of alternative dosing. Part B involves expanding participant groups to further test safety and early effectiveness of IM-1021 at doses chosen from Part A. Participants receive the study drug intravenously on an intermittent basis throughout these phases. Participants will undergo multiple assessments including monitoring for treatment-related adverse events, pharmacokinetic blood tests, and evaluations of anti-tumor effects from week 6 until disease progression or study discontinuation. Safety and tolerability will be tracked from the first dose until about 37 days after the last dose. The study duration spans from screening, treatment, and follow-up with data collection continuing up to the study end in 2029.
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 any study procedures
- Age 18 years or older
- ECOG performance status of 0, 1, or 2
- Histological or cytological diagnosis of advanced B-cell lymphomas or specific solid tumors including mantle cell lymphoma, diffuse large B-cell lymphoma, follicular lymphoma, small lymphocytic lymphoma, marginal zone lymphoma, pancreatic cancer, non-squamous non-small cell lung cancer, malignant mesothelioma, epithelial ovarian cancer, triple-negative breast cancer, or liposarcoma
- Adequate organ function
- Negative pregnancy test and willingness to use effective birth control
- Relapsed or refractory disease with prior receipt of all approved therapeutic options
- Measurable disease according to relevant criteria
You will not qualify if you...
- Prior treatment with an antibody-drug conjugate containing a topoisomerase-1 inhibitor payload, except limited prior ADC use in triple negative breast cancer
- Previous ROR1-targeted therapy
- History of anaphylactic reaction to irinotecan or severe gastrointestinal toxicity to prior irinotecan
- Life expectancy less than 12 weeks
- Prior solid organ transplant
- Symptomatic ascites or pleural effusion without clinical stability for at least 2 weeks after treatment
- Known active central nervous system disease without stability or appropriate treatment
- History of malignant primary brain tumor or other malignancy unless disease-free for at least 2 years
- Significant cardiac, pulmonary, or infectious diseases as detailed in the protocol
- Pregnancy, breastfeeding, or planning to conceive during the study
Research Team
I
Immunome Medical Monitor
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