105 Participants Needed

IMGS-001 for Advanced Cancer

Recruiting at 3 trial locations
CS
Overseen ByCharles Schweizer, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: ImmunoGenesis
Must be taking: GnRH analogs
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this Phase 1a/1b clinical trial is to test the safety of an investigational drug called IMGS-001 and to determine how well it can work in treating patients with advanced solid tumors that have come back or are not improving after receiving other drugs that are commonly used for their cancer. Phase 1a (Part 1) will test the safety of five different doses of IMGS-001 to use in further studies. Patients with cancer that have advanced or spread to other parts of the body following treatment with other available therapies will be treated in Part 1. Phase 1b (Part 2) will test two doses of IMGS-001 identified in Part 1 to further determine the safety and potential effectiveness in select cancer types.

Will I have to stop taking my current medications?

The trial requires that you stop taking any investigational or conventional anti-cancer drugs within 21 days before starting the trial. You also need to stop using immunosuppressive medications 14 days before starting, except for certain allowed ones. If you are on androgen deprivation therapy for prostate cancer, you must continue it.

What safety data exists for immune checkpoint inhibitors like IMGS-001 in humans?

Immune checkpoint inhibitors, which may include treatments like IMGS-001, are known to cause immune-related adverse events (irAEs), which can vary in severity. Most irAEs are mild and manageable with steroids, but some can be severe, requiring careful monitoring and management.12345

How is the treatment IMGS-001 different from other treatments for advanced cancer?

IMGS-001 is unique because it may involve the use of patient-derived models like micro-organospheres (MOSs) to guide personalized treatment decisions, allowing for rapid assessment of tumor response to therapies, including immuno-oncology treatments, within a short timeframe.678910

Are You a Good Fit for This Trial?

Adults with advanced solid tumors that have worsened after standard treatments can join this trial. They must have a specific type of tumor, adequate organ function, and no recent vaccines or other cancer therapies. People with certain blood counts, liver functions, and those who haven't had severe reactions to PD-1 or PD-L1 inhibitors may qualify.

Inclusion Criteria

My cancer tests positive for PD-L1.
To be included in cohorts with pre-existing immune checkpoint therapy, patients must fulfill the following requirements.
Your hemoglobin level is 9.0 g/dL or more.
See 22 more

Exclusion Criteria

I do not have severe autoimmune diseases but may have mild conditions like alopecia or celiac disease controlled by diet.
I haven't taken any cancer treatment or experimental drugs in the last 21 days.
I haven't used immunotherapy drugs like interleukin-2 or interferon in the last 28 days.
See 15 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1a Treatment

Dose-escalation study to determine the safety, tolerability, and maximum tolerated dose (MTD) of IMGS-001 in patients with advanced solid tumors

21 days
Every 2 weeks

Phase 1b Treatment

Dose-expansion study to assess preliminary antitumor activity of IMGS-001 in five prespecified tumor cohorts

12 months
Every 2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • IMGS-001
Trial Overview The trial is testing IMGS-001's safety at different doses for treating advanced solid tumors. Phase 1a finds the safest dose levels; Phase 1b tests these doses' effectiveness in select cancers with confirmed PD-L1 positive expression.
How Is the Trial Designed?
6Treatment groups
Experimental Treatment
Group I: Phase 1b Triple-negative Breast CancerExperimental Treatment1 Intervention
Group II: Phase 1b Ovarian CancerExperimental Treatment1 Intervention
Group III: Phase 1b Gastric or Esophageal CancerExperimental Treatment1 Intervention
Group IV: Phase 1b Colorectal CancerExperimental Treatment1 Intervention
Group V: Phase 1b Bladder CancerExperimental Treatment1 Intervention
Group VI: Phase 1a Solid TumorsExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

ImmunoGenesis

Lead Sponsor

Trials
3
Recruited
210+

Published Research Related to This Trial

A comprehensive review of 41 randomized controlled trials involving 23,121 patients found that treatments combining chemotherapy with immune checkpoint inhibitors (ICIs) significantly increased the risk of treatment-related adverse events compared to ICI-only regimens.
Among the various ICI treatments, the combination of PD-L1 and CTLA-4 with chemotherapy had the highest risk of immune-related adverse events, with severe cases like myocarditis and pneumonitis showing notably high fatality rates, indicating the need for careful monitoring and management in patients receiving these therapies.
Toxicity spectrum of immunotherapy in advanced lung cancer: A safety analysis from clinical trials and a pharmacovigilance system.Yan, YD., Zhao, Y., Zhang, C., et al.[2022]
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.
Immune-Related Adverse Events From Immune Checkpoint Inhibitors.Marrone, KA., Ying, W., Naidoo, J.[2022]
A dedicated inpatient service for managing high-grade immune-related adverse events (irAEs) from immune checkpoint inhibitors (ICIs) was established, successfully identifying 129 patients with significant irAEs over one year, primarily colitis and pneumonitis.
The service utilized electronic medical records to triage patients effectively, demonstrating a 26% readmission rate for recurrent irAEs, highlighting the need for ongoing monitoring and management of these patients.
Novel platform leveraging electronic medical record (EMR) to triage patients admitted with high-grade immune-related adverse events (irAEs) to the immune-toxicity (ITOX) service.Abu-Shawer, O., Singh, P., Yenulevich, E., et al.[2021]

Citations

Toxicity spectrum of immunotherapy in advanced lung cancer: A safety analysis from clinical trials and a pharmacovigilance system. [2022]
Immune-Related Adverse Events From Immune Checkpoint Inhibitors. [2022]
Novel platform leveraging electronic medical record (EMR) to triage patients admitted with high-grade immune-related adverse events (irAEs) to the immune-toxicity (ITOX) service. [2021]
Optimizing Care for Patients With Adverse Events From Immunotherapeutics. [2021]
Development of preclinical and clinical models for immune-related adverse events following checkpoint immunotherapy: a perspective from SITC and AACR. [2022]
A multicenter clinical study: personalized medication for advanced gastrointestinal carcinomas with the guidance of patient-derived tumor xenograft (PDTX). [2022]
Patient-derived micro-organospheres enable clinical precision oncology. [2023]
Quantifying epithelial-mesenchymal heterogeneity and EMT scoring in tumor samples via tyramide signal amplification (TSA). [2023]
Multi-institutional TSA-amplified Multiplexed Immunofluorescence Reproducibility Evaluation (MITRE) Study. [2022]
Implementation of a Multicenter Biobanking Collaboration for Next-Generation Sequencing-Based Biomarker Discovery Based on Fresh Frozen Pretreatment Tumor Tissue Biopsies. [2022]
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