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New treatment option for Solid Malignancies
Official title A Phase 1 Study of IM-1021 in Participants With Advanced Cancer
ClinicalTrials.gov ID: NCT06823167
What this study is testing
What is IM-1021?
IM-1021 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for solid malignancies.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- IM-1021-101 is a Phase 1 study to determine the safety and effectiveness of IM-1021 in treating participants with advanced cancer.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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)
You likely can't join if
- Previously treated with an ADC with a topoisomerase-1 inhibitor payload, except: Participants with triple negative breast cancer may have received up...
- Previously received a ROR1-targeted therapy (eg, ADC, cell therapy, or monoclonal antibody).
- History of an anaphylactic reaction to irinotecan or ≥ grade 3 GI toxicity to prior irinotecan.
- Life expectancy \< 12 weeks.
- Prior solid organ transplant.
- Participants with symptomatic ascites or pleural effusion. Participants who are clinically stable for at least 2 weeks following treatment for these...
See the full eligibility criteria
- 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) 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...
- 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 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...
- 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.
- Previously treated with an ADC with a topoisomerase-1 inhibitor payload, except: Participants with triple negative breast cancer may have received up to one prior ADC with a topoisomerase-1 inhibitor payload.
- Previously received a ROR1-targeted therapy (eg, ADC, cell therapy, or monoclonal antibody).
- History of an anaphylactic reaction to irinotecan or ≥ grade 3 GI toxicity to prior irinotecan.
- Life expectancy \< 12 weeks.
- Prior solid organ transplant.
- 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...
- 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...
- 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...
- Participant has certain other significant medical conditions including cardiac, pulmonary, and infectious disease as detailed in the protocol.
- Participant is pregnant, breastfeeding, or expecting to conceive within the projected duration of the study.
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Los Angeles, California, United States
- Denver, Colorado, United States
- New Haven, Connecticut, United States
- Atlanta, Georgia, United States
- Iowa City, Iowa, United States
- Louisville, Kentucky, United States
- Ann Arbor, Michigan, United States
- Grand Rapids, Michigan, United States
- Omaha, Nebraska, United States
- Charlotte, North Carolina, United States
- Canton, Ohio, United States
- Providence, Rhode Island, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- Irving, Texas, United States
- San Antonio, Texas, United States
- Copenhagen, Denmark
- Lyon, France
- Paris, France
+ 2 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Los Angeles, California, United States; Denver, Colorado, United States; New Haven, Connecticut, United States; Atlanta, Georgia, United States; Iowa City, Iowa, United States and 16 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.