RECRUITING

A Phase 1 Study of IM-1021 in Participants with Advanced Cancer

Conditions

Solid Malignancies Hematologic Malignancies

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

IM-1021-101 is a Phase 1 study to determine the safety and effectiveness of IM-1021 in treating participants with advanced cancer.

Official Title

A Phase 1 Study of IM-1021 in Participants with Advanced Malignancies

Quick Facts

Study Start:2025-02

Study Completion:2029-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06823167

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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: * Mantle cell lymphoma (MCL) * Diffuse large B-cell lymphoma (DLBCL) (including Richter's transformation) * Follicular lymphoma * Small lymphocytic lymphoma (SLL) * 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 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 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 available therapies with established benefit. Participants with B-cell malignancies should have received at least two lines of therapy, including available therapies with established benefit. Participants with SLL should have received at least three prior lines of therapy. 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.	1. Previously treated with an 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. 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 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) during the screening period. 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.

Inclusion Criteria

Exclusion 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:
* Mantle cell lymphoma (MCL)
* Diffuse large B-cell lymphoma (DLBCL) (including Richter's transformation)
* Follicular lymphoma
* Small lymphocytic lymphoma (SLL)
* 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
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 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 available therapies with established benefit. Participants with B-cell malignancies should have received at least two lines of therapy, including available therapies with established benefit. Participants with SLL should have received at least three prior lines of therapy.
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.

1. Previously treated with an 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. 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 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) during the screening period.
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.

Contacts and Locations

Study Contact

Immunome Medical Monitor

CONTACT

425.939.7410

info@immunome.com

Study Locations (Sites)

NEXT Oncology

Irving, Texas, 75039

United States

Collaborators and Investigators

Sponsor: Immunome, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02

Study Completion Date2029-02

Study Record Updates

Study Start Date2025-02

Study Completion Date2029-02

Terms related to this study

Additional Relevant MeSH Terms

Solid Malignancies
Hematologic Malignancies