IMSA101 + ICI for Advanced Cancer

Not currently recruiting at 1 trial location

Overseen By Teresa Mooneyham

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: ImmuneSensor Therapeutics Inc.

Must be taking: IMSA101

Disqualifiers: Discontinued IMSA101, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if continuing treatment with IMSA101, now combined with an immune checkpoint inhibitor (ICI), benefits those with advanced cancer who were already responding to IMSA101. The focus is on patients from a previous IMSA101 study who continue to show positive responses. Participants still benefiting from the earlier study may be suitable for this trial. 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 this promising combination therapy.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on continuing treatment with IMSA101 and an immune checkpoint inhibitor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that using IMSA101 with an immune checkpoint inhibitor (ICI) is generally safe for patients. Earlier studies found that people tolerated IMSA101 well at doses up to 2,400 micrograms when combined with ICIs. Notably, only 10.8% of patients experienced side effects related to the immune system's reaction to the treatment. This indicates that most people do not face serious side effects from this combination. Overall, the safety data supports the continued use of IMSA101, both alone and with ICIs, in ongoing trials. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Most treatments for advanced cancer involve traditional chemotherapy or immunotherapy, which can sometimes have limited effectiveness and significant side effects. IMSA101 is unique because it combines with an immune checkpoint inhibitor (ICI) to potentially enhance the body's own immune response against cancer cells. This novel combination aims to improve the effectiveness of immunotherapy by potentially activating a stronger and more targeted immune attack on tumors. Researchers are excited about this approach because it could offer a more powerful and precise treatment option with potentially fewer side effects compared to current therapies.

What evidence suggests that IMSA101 + ICI could be effective for advanced cancer?

Research has shown that combining IMSA101 with immune checkpoint inhibitors (ICIs) holds promise in fighting cancer. Early studies demonstrated that this combination can effectively target tumors. In this trial, participants will receive the combination therapy of IMSA101 and ICIs. One study confirmed that IMSA101 is safe and effective both alone and with other immune therapies. This combination therapy increased the number of patients whose tumors shrank and improved cancer control. Overall, these findings suggest that IMSA101 with ICIs could be a strong treatment option for advanced cancer. ^{3 4 5 6 7}

Who Is on the Research Team?

Teresa Mooneyham

Principal Investigator

ImmuneSensor Therapeutics

Are You a Good Fit for This Trial?

This trial is for adults with advanced solid tumors who were part of the IMSA101-101 study, are currently receiving IMSA101, and still seeing benefits. They must understand the consent form, have completed all assessments in the previous study, and agree to use two effective birth control methods if they can have children.

Inclusion Criteria

I am currently participating in the IMSA101-101 study and receiving IMSA101 treatment.

I agree to use two effective birth control methods during the study.

Deriving clinical benefit from study treatment, as determined by the investigator

Exclusion Criteria

Failure to meet the criteria specified in parent protocol IMSA101-101 for continued study treatment

Permanently discontinued from IMSA101 treatment in parent protocol IMSA101-101 for any reason other than enrollment in the rollover study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive IMSA101 in combination with an immune checkpoint inhibitor (ICI) with treatment cycles of 28 days, and lesions injected every 2 weeks

12 months

Bi-weekly visits for injections

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Immune Checkpoint Inhibitor
• IMSA101

Trial Overview The trial continues treatment from a previous study by giving patients IMSA101 along with an immune checkpoint inhibitor (ICI). It's designed for those who've already shown positive responses to these treatments and aims to further assess their effectiveness.

How Is the Trial Designed?

Group I: Combination Therapy Experimental Treatment 2 Interventions

IMSA101 + ICI

Who Is Running the Clinical Trial?

ImmuneSensor Therapeutics Inc.

Lead Sponsor

Trials

4

Recruited

60+

Published Research Related to This Trial

In a study of 65 patients undergoing interventional oncology therapies combined with immune checkpoint inhibitors, only 10.8% experienced immune-related adverse events (irAEs), mostly mild and manageable, indicating a favorable safety profile for this combination treatment.

The study found no severe complications (grade 5) related to the procedures or irAEs within 90 days, suggesting that combining tumor-directed therapies with immune checkpoint inhibitors is safe and does not lead to unexpected toxicities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thermal Ablation, Embolization, and Selective Internal Radiation Therapy Combined with Checkpoint Inhibitor Cancer Immunotherapy: Safety Analysis. Leppelmann, KS., Mooradian, MJ., Ganguli, S., et al.[2021]

Immune checkpoint inhibitor (ICI) combination therapy significantly improves objective response rates (ORR), disease control rates (DCR), progression-free survival (PFS), and overall survival (OS) in patients with advanced malignancies, based on a meta-analysis of 10 studies involving 2410 patients.

While ICI combination therapy shows enhanced efficacy compared to monotherapy, it is associated with a higher incidence of severe adverse events, including fatigue, nausea, and elevated liver enzymes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immune checkpoint inhibitor (ICI) combination therapy compared to monotherapy in advanced solid cancer: A systematic review. Ma, X., Zhang, Y., Wang, S., et al.[2021]

In a study of 12,283 patients with advanced non-small cell lung cancer (NSCLC) and other cancers, only 7-8% received PD-1/PD-L1 immune checkpoint inhibitors, primarily as second-line treatments, highlighting their limited use before widespread adoption.

Overall survival (OS) was significantly better for patients starting treatment with surgery (up to 25.6 months for NSCLC) compared to those receiving radiation therapy (as low as 3.9 months for NSCLC), indicating that treatment type greatly influences patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment and Survival in Advanced Non-Small Cell Lung Cancer, Urothelial, Ovarian, Gastric and Kidney Cancer: A Nationwide Comprehensive Evaluation. Sørup, S., Darvalics, B., Khalil, AA., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12182170/

Phase 1 first-in-human dose-escalation study of IMSA101, a ... Preclinical studies demonstrate antitumor activity of IMSA101 alone and in combination with immune-checkpoint inhibitors (ICIs). Methods.

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.TPS2685

Two phase 2A clinical trials to evaluate the safety and ... A recently concluded phase 1 clinical trial demonstrated the safety and efficacy of IMSA101 administered both as monotherapy and in combination with IO.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05846659

NCT05846659 | Study of PULSAR-ICI +/- IMSA101 in ... Phase 2, open-label, multicenter, randomized study comparing the safety and efficacy of personalized ultra-fractionated stereotactic adaptive radiotherapy ...

4. jitc.bmj.com jitc.bmj.com/content/11/Suppl_1/A704

618 Phase 1 clinical trial evaluating the safety, biologic and ... Pre-clinical studies demonstrate provocative anti-cancer activity both with IMSA alone and in combination with ICI and radiotherapy. Methods ...

5. withpower.com withpower.com/trial/phase-1-solid-tumors-adult-8-2023-1f47a

IMSA101 + ICI for Advanced Cancer · Info for Participants Immune checkpoint inhibitor (ICI) combination therapy significantly improves objective response rates (ORR), disease control rates (DCR), progression-free ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04020185

Safety and Efficacy Study of IMSA101 in Refractory ... Failure to recover to Grade 1 or less from clinically significant AEs due to prior anti-cancer therapy. Known untreated brain metastases or treated brain ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40533265/

Phase 1 first-in-human dose-escalation study of IMSA101, a ... Conclusions: IMSA101 doses of 1,200 µg (monotherapy arm) and 2,400 µg (combination therapy arm) were well tolerated but demonstrated minimal ...