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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

Study Summary

This trial studies a modified cytokine to treat solid tumors by helping recognize and kill tumor cells. Patients will receive the treatment in two phases, with dose escalation and expansion.

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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Assess DOR per RECIST 1.1 criteria

Assess ORR per RECIST 1.1 criteria

Assess PFS per RECIST 1.1 criteria

+1 more

Secondary outcome measures

Assess number of adverse events observed during treatment with DF6215

Evaluation of DF6215 Immunogenicity

Evaluation of DF6215 Pharmacokinetics

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

Find a Location

Who is running the clinical trial?

Dragonfly TherapeuticsLead Sponsor

3 Previous Clinical Trials

1,213 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the DF6215 Dose Escalation been sanctioned by the FDA?

"Our assessment of the drug DF6215 Dose Escalation's safety stands at a score of 1, since this is an early phase trial. This implies that there is limited evidence supporting its efficacy and safety."

Answered by AI

Are there still vacancies in this experiment?

"Clinical trials.gov indicates that this trial is not presently looking for participants, as the last update to its post was on October 25th 2023. Although this research study isn't recruiting at present, 2600 other clinical studies are actively enrolling patients across the U.S."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of DF6215 in Patients With Advanced Solid Tumors

2023. "Study of DF6215 in Patients With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06108479.

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