A Phase 1 Study of IM-1021 in Participants With Advanced Cancer
Recruiting
Phase 1Interventional Study
Solid MalignanciesHematologic Malignancies
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
190 (estimated)
Sponsor
Immunome, Inc. · Industry
Who this trial is looking for
This trial is looking for adults with advanced cancer to test a new treatment called IM-1021. Participants will receive this treatment to see how safe and effective it is for their condition.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I have signed the informed consent.
I have been diagnosed with advanced cancer, such as B-cell lymphoma or certain solid tumors.
I have measurable disease that can be assessed.
I have received all available approved treatments for my cancer.
I have good organ function.
I am willing to use birth control during the study.
I have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
You may not be able to join if
I have a history of severe reactions to irinotecan.
I have been diagnosed with a primary brain cancer or another active cancer.
I am pregnant, breastfeeding, or plan to conceive during the study.
I have received certain previous cancer treatments, including specific targeted therapies.
I have life expectancy less than 12 weeks.
I have significant medical conditions that affect my heart, lungs, or infections.
I have certain symptoms related to fluid buildup unless I am stable after treatment.
I have known active disease in my central nervous system.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
IM-1021-101 is a Phase 1 study to determine the safety and effectiveness of IM-1021 in treating participants with advanced cancer.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
1. Informed consent signed by the participant prior to conducting study-specific procedures
2. ≥18 years of age
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
4. Histological or cytological diagnosis of:
Part A: advanced B-cell lymphomas or sol…
Inclusion Criteria:
1. Informed consent signed by the participant prior to conducting study-specific procedures
2. ≥18 years of age
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
4. 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
5. Participants must have adequate organ function.
6. 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.
7. Participants must have relapsed or refractory disease and have received all approved and available therapeutic options.
8. 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.
Exclusion Criteria:
1. 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.
2. Previously received a ROR1-targeted therapy (eg, ADC, cell therapy, or monoclonal antibody).
3. History of an anaphylactic reaction to irinotecan or ≥ grade 3 GI toxicity to prior irinotecan.
4. Life expectancy \< 12 weeks.
5. Prior solid organ transplant.
6. 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 catheter) are eligible.
7. For participants with known active central nervous system (CNS) disease
1. For participants with solid tumors: Participant has a known active CNS primary tumor or metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks prior to study entry, have no radiological evidence of new or enlarging brain metastases, and are off steroids or on a stable dose up to an equivalent of prednisone 10 mg/day for at least 15 days prior to first dose of study medication. Participants who have symptoms consistent with CNS metastasis must have a negative magnetic resonance imaging (MRI) or other clinically appropriate imaging study if the participant is not able to undergo contrast-enhanced MRI and approved by the Sponsor Medical Monitor during the screening period.
2. For participants with lymphoma: Participant has active cerebral/meningeal disease related to the underlying malignancy. Participants with a history of cerebral/meningeal disease related to the underlying malignancy are allowed if prior CNS disease has been effectively treated and without progression for at least 3 months.
8. 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 no evidence of that disease for at least 2 years. Exception: The time requirement does not apply to participants who underwent successful definitive resection of certain cancers.
9. Participant has certain other significant medical conditions including cardiac, pulmonary, and infectious disease as detailed in the protocol.
10. Participant is pregnant, breastfeeding, or expecting to conceive within the projected duration of the study.
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