IM-1021 for Cancer

Recruiting at 7 trial locations

Overseen By Immunome Medical Monitor

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Immunome, Inc.

Must not be taking: Topoisomerase inhibitors, ROR1 therapies

Disqualifiers: Solid organ transplant, CNS tumor, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

117 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new treatment called IM-1021 to determine its safety and effectiveness for people with advanced cancer. It targets various cancers, including certain blood cancers like lymphoma and solid tumors such as pancreatic and lung cancer. The treatment is administered through an IV every 21 days. Suitable candidates have specific types of these cancers and have not responded to other treatments. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive it.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that IM-1021 is in the early stages of human testing, so limited information exists about its safety. However, lab tests have demonstrated strong effects against certain cancers, such as mantle cell lymphoma and triple-negative breast cancer. As this is the first human trial of IM-1021, assessing how well participants tolerate it is crucial. The trial aims to determine the treatment's safety and participants' reactions. Participants will receive the treatment in carefully controlled doses to monitor for any side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike standard cancer treatments that often rely on chemotherapy or radiation, IM-1021 is unique because it's administered intravenously and works by targeting cancer cells with a new mechanism of action. It uses a novel active ingredient that is specifically designed to interfere with the growth and spread of cancer cells, potentially offering a more focused approach with fewer side effects. Researchers are particularly excited about IM-1021 because it could provide a more effective and less toxic alternative to traditional cancer therapies, improving patient outcomes and quality of life.

What evidence suggests that IM-1021 might be an effective treatment for cancer?

Research has shown that IM-1021, the investigational treatment in this trial, has promising results in early studies. In tests with certain types of cancer, IM-1021 effectively reduced tumors. Specifically, one study found that 5 out of 8 subjects experienced complete tumor disappearance after treatment. Additionally, early observations in patients with B-cell lymphoma showed positive responses at different doses. These findings suggest that IM-1021 might help slow tumor growth in advanced cancers. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults with advanced B-cell lymphomas or solid tumors who have tried at least one standard treatment without success. They must be in fairly good health, not pregnant, and willing to use effective birth control. People can't join if they're expecting a short lifespan, have had certain previous treatments like ROR1-targeted therapy, severe reactions to irinotecan, organ transplants, active brain tumors/metastases, or significant other medical conditions.

Inclusion Criteria

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

I can take care of myself but may not be able to do heavy physical work.

My cancer is an advanced B-cell lymphoma or a specified solid tumor.

Exclusion Criteria

Life expectancy < 12 weeks

Participant is pregnant, breastfeeding, or expecting to conceive within the projected duration of the study

I have been treated with a ROR1-targeted therapy before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

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.

21-day cycles

Multiple visits (in-person)

Dose Expansion

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.

21-day cycles

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

30-37 days

What Are the Treatments Tested in This Trial?

Interventions

• IM-1021

Trial Overview The study tests IM-1021's safety and effectiveness on participants with advanced cancer. It's an early-stage (Phase 1) trial where researchers will closely monitor how well the drug works and what side effects it may cause as they determine the best dose.

How Is the Trial Designed?

Group I: Treatment Arm Experimental Treatment 1 Intervention

IM-1021 administered intravenously on a 21-day cycle, at a starting dose of 2 mg/kg.

Who Is Running the Clinical Trial?

Immunome, Inc.

Lead Sponsor

Trials

7

Recruited

420+

Published Research Related to This Trial

Adjuvant therapy with PD-1/PD-L1 inhibitors significantly improves overall survival (OS) and disease-free survival (DFS) in cancer patients, based on a meta-analysis of six randomized controlled trials involving 4,436 participants.

While these treatments offer substantial survival benefits, they are also associated with a higher risk of severe treatment-related adverse events (≥ grade 3), indicating a need for careful monitoring during therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of adjuvant therapy with PD‑1/PD‑L1 inhibitors in cancer. Mo, DC., Liang, ZY., Chen, L., et al.[2022]

Cancer immunotherapy, particularly through PD-1/PD-L1 inhibitors, has shown significant promise in treating various tumors while aiming to minimize toxic effects, as evidenced by the approval of several antibodies like nivolumab and pembrolizumab.

These inhibitors work by blocking the interaction between PD-1 and PD-L1, enhancing the immune response against cancer, and ongoing trials are focused on further evaluating their efficacy and safety compared to traditional chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tackling Cancer Resistance by Immunotherapy: Updated Clinical Impact and Safety of PD-1/PD-L1 Inhibitors. Abdin, SM., Zaher, DM., Arafa, EA., et al.[2022]

A total of 9202 adverse pulmonary events related to immune checkpoint inhibitors were identified, with common issues including pneumonitis, interstitial lung disease, and respiratory failure, indicating significant pulmonary toxicity associated with these treatments.

Most pulmonary immune-related adverse events were severe and contributed to a notable number of fatalities, suggesting that the risks of using immune checkpoint inhibitors may be underrecognized in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lessons from Pharmacovigilance: Pulmonary Immune-Related Adverse Events After Immune Checkpoint Inhibitor Therapy. Reese, SW., Cone, E., Marchese, M., et al.[2021]

Immune checkpoint inhibitors, such as those targeting CTLA-4, PD-1, and PD-L1, have become significant in cancer immunotherapy, showing promise in enhancing antitumor effects through both single-agent and combination therapies.

However, these therapies can lead to immune-related adverse events (irAEs), which vary in frequency and severity, highlighting the need for better understanding and management strategies for these side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immune-Related Adverse Events From Immune Checkpoint Inhibitors. Marrone, KA., Ying, W., Naidoo, J.[2022]

Immune checkpoint antibodies targeting the PD-1/PD-L1 pathway have shown significant antitumor activity and have been approved for use as single-agent therapies in metastatic malignant melanoma and nonsmall-cell lung cancer.

Understanding the toxicities associated with PD-1/PD-L1 blockade and having effective management strategies is crucial for maximizing both the safety and efficacy of these treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toxicities of the anti-PD-1 and anti-PD-L1 immune checkpoint antibodies. Naidoo, J., Page, DB., Li, BT., et al.[2023]

Citations

1. investors.immunome.com investors.immunome.com/immunome-presents-compelling-preclinical-data-demonstrating-robust-anti-tumor-activity-for-im-1021/

Immunome Presents Compelling Preclinical Data ... IM-1021 showed superior potency when compared to a competitor in both mantle cell lymphoma and triple-negative breast cancer preclinical ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06823167

NCT06823167 | A Phase 1 Study of IM-1021 in Participants ... Study Overview. IM-1021-101 is a Phase 1 study to determine the safety and effectiveness of IM-1021 in treating participants with advanced cancer.

3. synapse.patsnap.com synapse.patsnap.com/blog/preclinical-success-of-im-1021-in-reducing-tumor-growth-revealed-by-immunome

Preclinical Success of IM-1021 in Reducing Tumor Growth, ... In the MDA-MB-468 experiment, 5 out of 8 subjects displayed complete responses after receiving three doses of 5 mg/kg.

4. businesswire.com businesswire.com/news/home/20251023619001/en/Immunome-Presents-Preclinical-Data-Showing-Proprietary-TOP1i-ADC-Payload-HC74-Overcomes-Multiple-Mechanisms-of-ADC-Resistance

Immunome Presents Preclinical Data Showing Proprietary ... HC74 is a novel topoisomerase I inhibitor that serves as the payload in IM-1021, a ROR1-targeted ADC currently in a Phase 1 trial for solid and ...

5. firstwordpharma.com firstwordpharma.com/story/6517970

Immunome Reports Third Quarter 2025 Financial Results ... IM-1021: The Phase 1 clinical trial of IM-1021 is ongoing, with objective responses observed in B-cell lymphoma patients at multiple dose levels ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06823167

NCT06823167 | A Phase 1 Study of IM-1021 in Participants ... 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 ...

7. withpower.com withpower.com/trial/phase-1-hematologic-neoplasms-1-2025-53349

IM-1021 for Cancer IM-1021-101 is a Phase 1 study to determine the safety and effectiveness of IM-1021 in treating participants with advanced cancer. Show more. Do I need to stop ...

8. delta.larvol.com delta.larvol.com/Products/?ProductId=e274cce2-a78a-40d7-8a7e-4df63b03d185

IM-1021 / Immunome, Zentalis Pharma Preclinical • Breast Cancer • Hematological Malignancies • Lung Cancer • Lymphoma • Mantle Cell Lymphoma • Oncology • Solid Tumor • Triple Negative Breast ...

9. synapse.patsnap.com synapse.patsnap.com/article/immunome-administers-im-1021-in-first-patient-of-phase-1-ror1-adc-trial

Immunome Administers IM-1021 in First Patient of Phase 1 ... This trial marks the first human testing of IM-1021, an antibody-drug conjugate (ADC) targeting ROR1, a receptor often implicated in cancerous growths.