IM-1021 for Cancer

Recruiting at 3 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

Trial Summary

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.

What safety data exists for PD-1/PD-L1 inhibitors like IM-1021 in humans?

PD-1/PD-L1 inhibitors, which include treatments like IM-1021, have been associated with immune-related adverse events (side effects caused by the immune system) that can vary in frequency and severity. These treatments have been used in various cancers, and while they show promise, managing these side effects is important to ensure safety. ^{1 2 3 4 5}

What is the purpose of this trial?

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

Eligibility Criteria

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

My organs are working well.

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.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. Greece pubmed.ncbi.nlm.nih.gov

Efficacy and safety of adjuvant therapy with PD‑1/PD‑L1 inhibitors in cancer. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Lessons from Pharmacovigilance: Pulmonary Immune-Related Adverse Events After Immune Checkpoint Inhibitor Therapy. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Immune-Related Adverse Events From Immune Checkpoint Inhibitors. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Tackling Cancer Resistance by Immunotherapy: Updated Clinical Impact and Safety of PD-1/PD-L1 Inhibitors. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Toxicities of the anti-PD-1 and anti-PD-L1 immune checkpoint antibodies. [2023]