agenT-797 for Solid Tumors

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

34 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new immune cell therapy called agenT-797 in patients whose solid tumors have come back or didn't respond to other treatments. The therapy uses special immune cells from a donor to help the patient's body fight the cancer.

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.

What data supports the effectiveness of the drug agenT-797 for solid tumors?

The research highlights that targeting specific pathways in tumors with biological agents, like monoclonal antibodies, can enhance the effectiveness of traditional chemotherapy. Additionally, immunological checkpoint inhibitors, similar to those used in the trial, have shown significant improvements in survival for various cancers, suggesting potential benefits for solid tumors. ^{1 2 3 4 5}

What is the safety profile of immune checkpoint inhibitors like agenT-797?

Immune checkpoint inhibitors, including those like agenT-797, can cause side effects related to the immune system, such as skin issues, digestive problems, and effects on glands, liver, kidneys, and lungs. Most of these side effects can be managed by stopping the treatment or using medications like steroids, but some may require long-term hormone therapy. ^{6 7 8 9 10}

Research Team

Medical Director

Principal Investigator

MiNK Therapeutics

Eligibility Criteria

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

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

Treatment Details

Interventions

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

Participant Groups

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+

Findings from Research

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 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]

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]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Molecular markers and targeted therapy with novel agents: prospects in the treatment of non-small cell lung cancer. [2019]

2. Germany pubmed.ncbi.nlm.nih.gov

[Pharmacotherapy of solid tumors. New hopes and frustrations]. [2021]

3. Ireland pubmed.ncbi.nlm.nih.gov

Ovarian tumor growth regression using a combination of vascular targeting agents anginex or topomimetic 0118 and the chemotherapeutic irofulven. [2021]

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

Irinotecan is an active agent in untreated patients with metastatic colorectal cancer. [2018]

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

Benchmarking single-arm studies against historical controls from non-small cell lung cancer trials - an empirical analysis of bias. [2020]

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

Programmed Death-1 Inhibition in Cancer With a Focus on Non-Small Cell Lung Cancer: Rationale, Nursing Implications, and Patient Management Strategies. [2017]

7. England pubmed.ncbi.nlm.nih.gov

Adverse event profile for immunotherapy agents compared with chemotherapy in solid organ tumors: a systematic review and meta-analysis of randomized clinical trials. [2022]

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

Adverse reactions associated with immune checkpoint inhibitors and bevacizumab: A pharmacovigilance analysis. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Safety profile of immune checkpoint inhibitors: An analysis of the Italian spontaneous reporting system database. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Decoding kinase-adverse event associations for small molecule kinase inhibitors. [2022]