agenT-797 for Solid Tumors

No longer recruiting at 8 trial locations

Overseen By MiNK Therapeutics Clinical Trial Information

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: MiNK Therapeutics

Must be taking: Immune checkpoint inhibitors

Disqualifiers: Concurrent malignancy, Untreated brain metastases, others

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

Compensation: Varies

Number of Visits: 1

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called agenT-797 for individuals with solid tumors that have returned or not responded to other treatments. The study aims to determine the therapy's safety, tolerability, and any early signs of effectiveness. One part of the trial uses agenT-797 alone, while another combines it with existing treatments like pembrolizumab or nivolumab, which enhance the immune system's ability to fight cancer. Suitable participants have solid tumors unresponsive to standard treatments and are willing to continue their current medications if part of the combination treatment group. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on pembrolizumab or nivolumab, you must continue taking them while participating in the study.

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

Research has shown that agenT-797 is generally safe. In a study involving 82 patients who had undergone previous treatments, none experienced severe Cytokine Release Syndrome, a strong immune reaction. This indicates that the treatment was well-tolerated. Although this trial is in its early stages, these results are encouraging for potential participants. It is important to note that early-phase trials primarily focus on assessing safety and the body's response to the treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for solid tumors, which often include chemotherapy, radiation, or immunotherapy alone, agenT-797 offers a novel approach by using an experimental allogeneic therapy. Researchers are excited because agenT-797 involves infusing immune cells that are engineered to enhance the body's natural ability to fight cancer, potentially offering a more targeted and powerful response. Additionally, in combination with approved immune checkpoint inhibitors (ICIs), agenT-797 might amplify the effectiveness of existing treatments, potentially improving outcomes for patients. This dual approach aims to harness and boost the immune system in innovative ways, setting it apart from current therapies.

What evidence suggests that this trial's treatments could be effective for solid tumors?

Studies have shown promising early results for agenT-797, a new cell therapy for solid tumors. This therapy uses iNKT cells, special immune cells that strengthen the body's natural defenses against cancer. Initial findings suggest that agenT-797 can shrink tumors, with some patients experiencing a significant decrease in liver and bone tumors. In some cases, tumor cells reduced by more than 50%. In this trial, participants may receive agenT-797 as a monotherapy or combined with approved immune checkpoint inhibitors (ICIs). When used with approved ICIs, agenT-797 may help overcome resistance to traditional cancer treatments, potentially improving patient outcomes. ^{1 2 3 6 7}

Who Is on the Research Team?

Medical Director

Principal Investigator

MiNK Therapeutics

Are You a Good Fit for This Trial?

Inclusion Criteria

Measurable disease per RECIST 1.1 as assessed by local site Investigator/radiology. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions

Histological or cytological evidence of relapsed or refractory solid tumor malignancy for which no standard therapy is available or standard therapy has failed

Part 2 only, participants must have progressed per Investigator assessment on pembrolizumab or nivolumab, and agree and are able to continue on the inhibitor(s) while on study

Exclusion Criteria

You have another type of cancer at the same time.

You have cancer that has spread to your brain or the covering of your brain and it is either not being treated or is currently being treated.

Prior radiotherapy within 2 weeks of start of study treatment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive agenT-797 as a single agent or in combination with approved immune checkpoint inhibitors

12 months

Multiple visits including Day 1, Days 2, 5, 8, 15, 22, 29; Weeks 6, 8, 12; and Months 6, 9, 12

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• agenT-797
• Approved anti-PD-1
• Approved ICIs

How Is the Trial Designed?

Group I: Part 2: agenT-797 in Combination with approved ICIs Experimental Treatment 2 Interventions

Single prespecified dose of agenT-797 administered by IV infusion in combination with approved ICIs administered in accordance with manufacturer instructions and institutional guidelines as per standard of care

Group II: Part 1: Monotherapy with agenT-797 Experimental Treatment 1 Intervention

3+3 Dose escalation of agenT-797 will be administered as a single intravenous (IV) infusion.

Who Is Running the Clinical Trial?

MiNK Therapeutics

Lead Sponsor

Trials

3

Recruited

70+

Published Research Related to This Trial

A large-scale retrospective study of 2094 cases from the FDA adverse event reporting system found that combining immune checkpoint inhibitors with bevacizumab significantly increases the risk of adverse drug reactions (ADRs) in cancer patients, particularly interstitial lung disease, hypertension, and gastrointestinal bleeding.

The study highlights that combination therapy is an independent risk factor for these ADRs, suggesting the need for careful monitoring and individualized management strategies for patients undergoing this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse reactions associated with immune checkpoint inhibitors and bevacizumab: A pharmacovigilance analysis. Gu, T., Jiang, A., Zhou, C., et al.[2023]

Targeted and immunological therapies have significantly improved survival rates in patients with solid tumors, demonstrating the effectiveness of treatments that focus on specific genetic and immunological changes in tumors.

Current clinical trials are exploring the optimal timing and sequencing of these therapies, which include various approved agents for cancers like prostate, breast, lung, and melanoma, indicating a shift towards more personalized cancer treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Pharmacotherapy of solid tumors. New hopes and frustrations]. Grünwald, V., Rickmann, M.[2021]

A review of 2217 adverse drug reaction reports related to immune checkpoint inhibitors (ICIs) from 2011 to 2018 revealed that these drugs, particularly nivolumab, are associated with a higher frequency of serious immune-related adverse events, including gastrointestinal and respiratory disorders.

Emerging safety signals, such as ischaemic heart disease and cardiac failure, were identified, indicating the need for further investigation into the long-term safety profile of ICIs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety profile of immune checkpoint inhibitors: An analysis of the Italian spontaneous reporting system database. Cutroneo, PM., Isgrò, V., Ientile, V., et al.[2021]

A machine-learning model was developed using data from 4638 patients across 16 FDA-approved small molecule kinase inhibitors (SMKIs) to analyze the relationship between kinase targets and adverse events (AEs), providing a new tool for predicting safety risks in cancer treatments.

The model not only helps identify potential kinase-inhibitor adverse event pairs but also serves as a precision medicine tool to enhance patient safety by forecasting clinical safety signals and aiding in the development of safer SMKI therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decoding kinase-adverse event associations for small molecule kinase inhibitors. Gong, X., Hu, M., Liu, J., et al.[2022]

Citations

1. investor.minktherapeutics.com investor.minktherapeutics.com/news-releases/news-release-details/mink-therapeutics-present-late-breaking-data-agent-797-solid

Press Release MiNK Therapeutics to Present Late-Breaking Data on AgenT-797 in Solid Tumors at the 40th Annual Society for Immunotherapy of Cancer (SITC) ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05108623

NCT05108623 | A Study Investigating agenT-797 in ... This is a Phase 1, open-label study to explore the safety, tolerability, and preliminary clinical activity of agenT-797, an unmodified, allogeneic iNKT cell ...

3. finance.yahoo.com finance.yahoo.com/news/mink-therapeutics-present-breaking-data-130000526.html

MiNK Therapeutics to Present Late-Breaking Data on ... Its lead candidate, AgenT-797, is an off-the-shelf, cryopreserved iNKT cell therapy currently in clinical trials for solid tumors, graft-versus- ...

4. investingnews.com investingnews.com/mink-therapeutics-to-present-late-breaking-data-on-agent-797-in-solid-tumors-at-the-40th-annual-society-for-immunotherapy-of-cancer-meeting/

MiNK Therapeutics to Present Late-Breaking Data ... AgenT-797 is an off-the-shelf iNKT cell therapy designed to reprogram the immune system and overcome resistance to conventional immunotherapies.

5. jitc.bmj.com jitc.bmj.com/content/10/Suppl_2/A678

647 Phase I studies of AgenT-797, a novel allogeneic ... Enrollment is ongoing with early observations including reduction of liver mets and SD>3 (Rectal) and >50% reduction of tumor cells in bone ...

6. trial.medpath.com trial.medpath.com/news/19fd2d78729c2735/mink-therapeutics-reports-durable-clinical-activity-for-agent-797-inkt-cell-therapy-in-advanced-solid-tumors

MiNK Therapeutics Reports Durable Clinical Activity for AgenT ... MiNK Therapeutics will present late-breaking Phase 1 data showing durable clinical activity of AgenT-797, an allogeneic iNKT cell therapy, ...

7. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.4_suppl.TPS515

A phase II study of agenT-797 (invariant natural killer T- ... In a cohort of 82 previously treated patients, agenT-797 demonstrated a favorable safety profile with no severe Cytokine Release Syndrome, ...