Informations générales (source: ClinicalTrials.gov)
A Phase 1 Study of IM-1021 in Participants With Advanced Malignancies
Interventional
Phase 1
Immunome, Inc. (Voir sur ClinicalTrials)
février 2025
février 2029
11 août 2026
IM-1021-101 is a Phase 1 study to determine the safety and effectiveness of IM-1021 in
treating participants with advanced cancer.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Vincent RIBRAG | 17/06/2026 09:50:06 | Contacter | ||
Critères
Tous
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.