What is the mechanism of action of this treatment?

Common treatments for solid tumors, such as Modified Interleukin-2 (IL-2), work by enhancing the activity of lymphocytes to recognize and kill tumor cells. This is important for solid tumor patients because it utilizes the body's immune system to target cancer cells, potentially leading to more effective and long-lasting responses. Other immunotherapies, like checkpoint inhibitors, block proteins that inhibit the immune system, further boosting the body's ability to fight cancer. These mechanisms are crucial as they offer a targeted approach, potentially reducing side effects and improving outcomes compared to traditional treatments.

What side effects are associated with this type of intervention?

Treatments for solid tumors, particularly immunotherapies like modified Interleukin-2 (IL-2), often cause side effects such as flu-like symptoms (fever, chills, fatigue), gastrointestinal issues (nausea, vomiting, diarrhea), and immune-related adverse events including inflammation in various organs (colitis, hepatitis, pneumonitis). Other common side effects include skin reactions, infusion-related reactions, and potential endocrine disorders.

What prior FDA approvals exist?

The FDA has approved several immunotherapies for the treatment of solid tumors that enhance lymphocyte activity. Notably, high-dose Interleukin-2 (IL-2) has been approved for metastatic renal cell carcinoma and metastatic melanoma, leveraging its ability to stimulate lymphocytes to attack tumor cells. Additionally, immune checkpoint inhibitors such as nivolumab and pembrolizumab, which target PD-1/PD-L1 pathways, have been approved for various solid tumors, including non-small cell lung cancer and melanoma. These treatments work by enhancing the immune system's ability to recognize and destroy cancer cells.

What other types of research exist?

Promising novel alternatives to Modified Interleukin-2 (IL-2) for solid tumor patients include: 1) Pembrolizumab and Dostarlimab for patients with dMMR or high TMB metastatic CRPC, 2) Combination therapies such as Ramucirumab plus Pembrolizumab for advanced NSCLC, 3) Anti-PD-1 or PD-L1 therapies combined with chemotherapy or other agents for various cancers, and 4) Fecal Microbiota Transplantation (FMT) to enhance immunotherapy response in melanoma. These alternatives are based on emerging data and ongoing clinical trials.

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Cytokine

DF6215 for Solid Tumors

Phase 1

Recruiting

Research Sponsored by Dragonfly Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at study entry and an estimated life expectancy of at least 3 months

Male or female patients aged ≥ 18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from time of initiation of therapy until the date of first documented tumor progression, assessed up to 24 months.

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a modified protein that helps the immune system fight cancer in patients with solid tumors by making it easier for immune cells to find and destroy cancer cells.

Who is the study for?

This trial is for adults over 18 with advanced solid tumors where standard treatments have failed or don't exist. They should be relatively healthy (ECOG status of 0 or 1) and expected to live at least another three months. Participants need good blood and heart function, and must use effective birth control.

What is being tested?

The study tests DF6215, a modified cytokine aimed at boosting the immune system's ability to fight cancer. It has two parts: first, finding the right dose; second, expanding that dose to more patients with specific types of solid tumors.

What are the potential side effects?

While not explicitly listed here, side effects may include typical reactions related to immune system activation such as fever, fatigue, rash or allergic reactions. Organ-specific inflammation could also occur due to enhanced immune activity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am mostly active and my doctor thinks I have at least 3 months to live.

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I am 18 years old or older.

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My advanced cancer has no standard treatment left or treatments have failed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from time of initiation of therapy until the date of first documented tumor progression, assessed up to 24 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from time of initiation of therapy until the date of first documented tumor progression, assessed up to 24 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from time of initiation of therapy until the date of first documented tumor progression, assessed up to 24 months. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Assess DOR per RECIST 1.1 criteria

Assess ORR per RECIST 1.1 criteria

Assess PFS per RECIST 1.1 criteria

+1 more

Secondary study objectives

Assess number of adverse events observed during treatment with DF6215

Evaluation of DF6215 Immunogenicity

Evaluation of DF6215 Pharmacokinetics

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: DF6215 Safety/PK/PDExperimental Treatment1 Intervention

Expansion cohorts of DF6215 in multiple dose levels after evaluation for safety in the DF6215 Dose Escalation arm. Additional Pharmacokinetic (PK) and Pharmacodynamic (PD) samples included in this arm.

Group II: DF6215 Expansion in Advanced MelanomaExperimental Treatment1 Intervention

Expansion cohort enrolling 20 patients with advanced melanoma who have progressed after an anti-PD-1 containing regimen using the dose selected for Phase 1b identified in the DF6215 Dose Escalation arm.

Group III: DF6215 Dose EscalationExperimental Treatment1 Intervention

Dose escalation cohorts of DF6215 in sequential ascending order.

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for solid tumors, such as Modified Interleukin-2 (IL-2), work by enhancing the activity of lymphocytes to recognize and kill tumor cells. This is important for solid tumor patients because it utilizes the body's immune system to target cancer cells, potentially leading to more effective and long-lasting responses. Other immunotherapies, like checkpoint inhibitors, block proteins that inhibit the immune system, further boosting the body's ability to fight cancer. These mechanisms are crucial as they offer a targeted approach, potentially reducing side effects and improving outcomes compared to traditional treatments.

Promising immunotherapy for prostate cancer.