A Phase 1 Study of IM-1021 in Participants With Advanced Cancer
Cancer-Related Syndrome
Gynecologic Cancers
Ovarian Cancer
Primary Peritoneal Cancer
Sarcoma
18 Years and older, Male and Female
IM-1021-101 (primary)
NCI-2025-03470
Summary
IM-1021-101 is a Phase 1 study to determine the safety and effectiveness of IM-1021 in
treating participants with advanced cancer.
Objectives
IM-1021-101 is a 2-part Phase 1 first-in-human, open-label, multicenter dose escalation
and expansion study designed to determine the safety, tolerability, pharmacokinetics
(PK), and preliminary anti-tumor activity of the ROR1 directed antibody-drug conjugate
(ADC) IM-1021. IM-1021 will be administered to participants with advanced B-cell
lymphomas and advanced solid tumors. Part A of the study is a dose escalation phase to
evaluate safety and tolerability of IM-1021 and to determine recommended doses for
further development. IM-1021 will be administered intravenously on an intermittent basis.
The safety and tolerability of escalating doses of IM-1021 will be evaluated. Alternative
dosing schedules may also be evaluated. Part B of the study is an expansion phase to
further evaluate safety and tolerability of IM-1021 at candidate recommended doses in
indication specific cohorts of participants. The safety and preliminary efficacy
endpoints of this study will inform a preliminary risk-benefit assessment of IM-1021 in
this patient population.
Eligibility
- 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)
- Marginal zone lymphoma 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
- Participants must have adequate organ function.
- 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.
- Participants must have relapsed or refractory disease and have received all approved and available therapeutic options.
- 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.
Treatment Sites in Georgia
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