Solid MalignanciesPhase 1NCT06823167
A Phase 1 Study of IM-1021 in Participants With Advanced Cancer
A Phase 1 study testing IM-1021 in people with Solid Malignancies and Hematologic Malignancies, run by Immunome, Inc. at 24 sites in 4 countries.
Trial summary
IM-1021-101 is a Phase 1 study to determine the safety and effectiveness of IM-1021 in treating participants with advanced cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Malignancies, Hematologic Malignancies
- What is being tested?
- IM-1021
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 24 sitesin 4 countries
- Study dates
- 26 Feb 2025to Feb 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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 catheter) are eligible.
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- For participants with known active central nervous system (CNS) disease
- 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.
- 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.
- 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.
- 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.
Trial locations and contacts
24 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
24 sites in 4 countries
United States19 sites, 19 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
- Recruiting
Emory Winship Cancer Institute
Atlanta, Georgia, 30322
- Recruiting
Gabrail Cancer Center
Canton, Ohio, 44718
- Recruiting
Levine Cancer Institute
Charlotte, North Carolina, 28204
- Recruiting
University of Virginia
Charlottesville, Virginia, 22903
- Recruiting
Colorado Blood Cancer Institute
Denver, Colorado, 80218
- Recruiting
City Of Hope
Duarte, California, 91010
- Recruiting
START Midwest
Grand Rapids, Michigan, 49546
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
- Recruiting
University of Iowa
Iowa City, Iowa, 52242
- Recruiting
NEXT Oncology
Irving, Texas, 75039
- Recruiting
University of California
Los Angeles, California, 90095
- Recruiting
Norton Cancer Institute
Louisville, Kentucky, 40202
- Recruiting
Sarah Cannon Research Institute - Oncology Partners
Nashville, Tennessee, 37203
- Recruiting
Yale University Medical Center
New Haven, Connecticut, 06510
- Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, 68105
- Recruiting
Brown University
Providence, Rhode Island, 02903
- Recruiting
UT San Antonio Mays Cancer
San Antonio, Texas, 78229
- Recruiting
Tampa General Hospital
Tampa, Florida, 33606
France3 sites, 3 recruiting
- Recruiting
Centre Leon-Berard
Lyon, 69008
- Recruiting
LITO, Institut Curie Hospital Gropu
Paris, 75005
- Recruiting
Gustave Roussy
Villejuif, 94805
Denmark1 site, 1 recruiting
- Recruiting
Copenhagen University Hospital
Copenhagen, DK-2100
Spain1 site, 1 recruiting
- Recruiting
START - Fundacion Jimenez Diaz
Madrid, 28040
About this study
Official title: A Phase 1 Study of IM-1021 in Participants With Advanced Malignancies
IM-1021-101 is a Phase 1 study to determine the safety and effectiveness of IM-1021 in treating participants with advanced cancer.
Read the detailed description
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.
- Conditions
- Solid Malignancies, Hematologic Malignancies
- Being tested
- IM-1021
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IM-1021Drug
IM-1021 is an antibody-drug conjugate
| Study group | Role | What they receive |
|---|---|---|
| Part A: IM-1021 Dose Escalation | Experimental | IM-1021 given into the vein (IV; intravenously) Receives: Drug: IM-1021 |
| Part B: IM-1021 Monotherapy Dose Expansion | Experimental | IM-1021 given into the vein (IV; intravenously) Receives: Drug: IM-1021 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of IM-1021 in participants with advanced lymphomas and advanced solid tumors as measured by incidence of treatment emergent adverse events (TEAEs)
Type, frequency, seriousness, and severity of adverse events (AEs) graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria version 5.0, including serious adverse events (SAEs), AEs of interest (AEI), AEs leading to discontinuation, and deaths
Measured: From first dose to 37 days following last dose of study treatment
Determine the recommended dose(s) and schedule(s) of IM-1021 for further development
Type, frequency, seriousness, and severity of AEs graded using the NCI-CTCAE v6.0, including SAEs, AEIs, AEs leading to discontinuation, and deaths
Measured: From first dose to 37 days following last dose of study treatment
Secondary outcomes (10)
Area under the concentration-time curve (AUC) of IM-1021 in participants with advanced lymphomas and advanced solid tumors
Pharmacokinetic (PK) parameter
Measured: Through 30-37 days following last dose of IM-1021 up to end of study
Concentration at end of infusion (Ceoi) of IM-1021 in participants with advanced lymphomas and advanced solid tumors
PK parameter
Measured: Through 30-37 days following last dose of IM-1021 up to end of study
Maximum observed concentration (Cmax) of IM-1021 in participants with advanced lymphomas and advanced solid tumors
PK parameter
Measured: Through 30-37 days following last dose of IM-1021 up to end of study
Time to maximum observed concentration (Tmax) of IM-1021 in participants with advanced lymphomas and advanced solid tumors
PK parameter
Measured: Through 30-37 days following last dose of IM-1021 up to end of study
Trough Concentration of IM-1021 in participants with advanced lymphomas and advanced solid tumors
PK parameter
Measured: Through 30-37 days following last dose of IM-1021 up to end of study
Apparent Terminal Half-Life (t1/2) of IM-1021 in participants with advanced lymphomas and advanced solid tumors
PK parameter
Measured: Through 30-37 days following last dose of IM-1021 up to end of study
Characterize the immunogenicity of IM-1021
Determined by the incidence of anti-drug antibodies (ADA) to IM-1021 from pre-infusion sample prior to each cycle.
Measured: From first dose to about 30 days following last dose of study treatment
To evaluate the preliminary anti-tumor activity of IM-1021 in participants with advanced lymphomas and advanced solid tumors
Objective response rate (ORR) as measured by Lugano Classification for participants with lymphoma (except small lymphocytic lymphoma [SLL]), per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria for participants with SLL, and per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 for participants with solid tumors
Measured: Week 6 until disease progression or participant discontinuation from study
To evaluate the preliminary anti-tumor activity of IM-1021 in participants with advanced lymphomas and advanced solid tumors
Complete response rate (CRR) as measured by Lugano Classification for participants with lymphoma (except SLL), per iwCLL criteria for participants with SLL, and per RECIST v.1.1 for participants with solid tumors
Measured: Week 6 until disease progression or participant discontinuation from study
To evaluate the preliminary anti-tumor activity of IM-1021 in participants with advanced lymphomas and advanced solid tumors
Disease control rate (DCR) as measured by Lugano Classification for participants with lymphoma (except SLL), per iwCLL criteria for participants with SLL, and per RECIST v.1.1 for participants with solid tumors
Measured: Week 6 until disease progression or participant discontinuation from study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start26 Feb 2025
- Primary completionMay 2028 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid MalignanciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Immunome, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06823167
- Sponsor's protocol ID
- IM-1021-101
- Status last verified
- Aug 2026
- First submitted
- 4 Feb 2025
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of IM-1021 in Participants With Advanced Malignancies
- ClinicalTrials.gov ID
- NCT06823167
- Acronym / sponsor ID
- IM-1021-101
- Conditions
- Solid Malignancies, Hematologic Malignancies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Immunome, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Feb 2025 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 12 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
IM-1021-101 is a Phase 1 study to determine the safety and effectiveness of IM-1021 in treating participants with advanced cancer.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A: IM-1021 Dose Escalation | Experimental | Drug: IM-1021IM-1021 given into the vein (IV; intravenously) |
| Part B: IM-1021 Monotherapy Dose Expansion | Experimental | Drug: IM-1021IM-1021 given into the vein (IV; intravenously) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- 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:
- Other, unlisted histologies, if approved by the Sponsor Medical Monitor
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IM-1021IM-1021 is an antibody-drug conjugate | Drug | Part A: IM-1021 Dose Escalation, Part B: IM-1021 Monotherapy Dose Expansion |
Primary outcome
Safety and tolerability of IM-1021 in participants with advanced lymphomas and advanced solid tumors as measured by incidence of treatment emergent adverse events (TEAEs)
Time frame: From first dose to 37 days following last dose of study treatment
Type, frequency, seriousness, and severity of adverse events (AEs) graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria version 5.0, including serious adverse events (SAEs), AEs of interest (AEI), AEs leading to discontinuation, and deaths
Determine the recommended dose(s) and schedule(s) of IM-1021 for further development
Time frame: From first dose to 37 days following last dose of study treatment
Type, frequency, seriousness, and severity of AEs graded using the NCI-CTCAE v6.0, including SAEs, AEIs, AEs leading to discontinuation, and deaths
10 secondary outcomes
Area under the concentration-time curve (AUC) of IM-1021 in participants with advanced lymphomas and advanced solid tumors
Time frame: Through 30-37 days following last dose of IM-1021 up to end of study
Concentration at end of infusion (Ceoi) of IM-1021 in participants with advanced lymphomas and advanced solid tumors
Time frame: Through 30-37 days following last dose of IM-1021 up to end of study
Maximum observed concentration (Cmax) of IM-1021 in participants with advanced lymphomas and advanced solid tumors
Time frame: Through 30-37 days following last dose of IM-1021 up to end of study
Time to maximum observed concentration (Tmax) of IM-1021 in participants with advanced lymphomas and advanced solid tumors
Time frame: Through 30-37 days following last dose of IM-1021 up to end of study
Trough Concentration of IM-1021 in participants with advanced lymphomas and advanced solid tumors
Time frame: Through 30-37 days following last dose of IM-1021 up to end of study
Apparent Terminal Half-Life (t1/2) of IM-1021 in participants with advanced lymphomas and advanced solid tumors
Time frame: Through 30-37 days following last dose of IM-1021 up to end of study
Characterize the immunogenicity of IM-1021
Time frame: From first dose to about 30 days following last dose of study treatment
To evaluate the preliminary anti-tumor activity of IM-1021 in participants with advanced lymphomas and advanced solid tumors
Time frame: Week 6 until disease progression or participant discontinuation from study
To evaluate the preliminary anti-tumor activity of IM-1021 in participants with advanced lymphomas and advanced solid tumors
Time frame: Week 6 until disease progression or participant discontinuation from study
To evaluate the preliminary anti-tumor activity of IM-1021 in participants with advanced lymphomas and advanced solid tumors
Time frame: Week 6 until disease progression or participant discontinuation from study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
24 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IM-1021 in people with Solid Malignancies and Hematologic Malignancies, run by Immunome, Inc. at 24 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, France, Denmark, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Immunome Medical Monitor (425.939.7410, info@immunome.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of IM-1021 in participants with advanced lymphomas and advanced solid tumors as measured by incidence of treatment emergent adverse events (TEAEs) (time frame: From first dose to 37 days following last dose of study treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.