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RecruitingLast updated: 3 April 2024

This study is investigating how safe, tolerable and effective a new treatment (called DF6215) is in people with advanced solid cancersA Phase 1/1b, First-In-Human, Multi-Part, Open-Label Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of DF6215 in Patients With Advanced (Unresectable, Recurrent, or Metastatic) Solid Tumors

Clinical summary

Summary

DF6215-001 is a study of a modified human cytokine (interleukin-2; IL-2) that retains the ability to bind to a certain part of the IL-2 receptor on a subset of white blood cells (lymphocytes), which can help recognize and kill tumor cells. 

This study will have two phases. The first phase will be a dose escalation phase, enrolling people with various types of solid cancers into cohorts who will receive DF6215 in sequential ascending order.

The second phase, Phase 1b, will include a dose expansion using the best dose selected from the first phase of the study. A cohort will be opened with eligible patients having a select solid cancer ( advanced melanoma).

Conditions

This trial is treating patients with advanced solid cancers

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I

More information

Trial Identifiers

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Trial sponsor

Dragonfly Therapeutics

Scientific Title

A Phase 1/1b, First-In-Human, Multi-Part, Open-Label Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of DF6215 in Patients With Advanced (Unresectable, Recurrent, or Metastatic) Solid Tumors

Eligibility

Inclusion

Key Inclusion Criteria - General (applies to all cohorts)

  • Signed written informed consent
  • Male or female patients aged ≥ 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at study entry and an estimated life expectancy of at least 3 months
  • Adequate hematological function
  • Adequate cardiac function
  • Effective contraception

Inclusion Criteria - 3+3 Dose Escalation

  • Histologically or cytologically proven locally advanced or metastatic solid tumor, for which no standard therapy exists, or standard therapy has failed
  • Evidence of objective disease (but participation does not require a measurable lesion)
  • Archived tumor biopsy. If archival tissue is unavailable, a fresh tumor biopsy is required, obtained within the screening window.

Inclusion Criteria - Safety/PK/PD

  • Histologically or cytologically proven locally advanced or metastatic solid tumor from the following list, where standard therapy does not exist or has failed:

    • Melanoma
    • HPV-positive advanced malignancies
    • Ovarian cancer
    • Head and neck cancer
    • Lung cancer (non-small-cell lung cancer [NSCLC])
    • Renal cell carcinoma (RCC)
    • Other tumor types may be eligible after discussion with the Sponsor medical monitor
  • Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST 1.1
  • A fresh tumor biopsy must be obtained during the screening window and on-treatment

Inclusion Criteria - Efficacy Expansion

  • Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST 1.1
  • A fresh tumor biopsy must be obtained during the screening window and on-treatment

Exclusion

Key Exclusion Criteria - General (applies to all cohorts)

  • Patients receiving chemotherapy, radiotherapy (other than palliative bone-directed radiotherapy), major surgery, or receiving another therapeutic agent within 28 days before the start of study drug or within 5 half-lives of the previous therapeutic agent (if known), whichever is shorter
  • Concurrent anticancer treatment (eg, cytoreductive therapy, radiotherapy [except for palliative bone-directed radiotherapy], immune therapy, or cytokine therapy [except for erythropoietin]), major surgery (excluding prior diagnostic biopsy), concurrent systemic therapy with steroids or other immunosuppressive agents, or use of any investigational drug within 28 days before the start of treatment or within 5 half-lives of the previous therapeutic agent (if known), whichever is shorter. Short-term administration of systemic steroids (eg, for allergic reactions or the management of immune-related adverse events [irAEs]) is allowed.

    • Note: Patients receiving bisphosphonate or denosumab are eligible, provided treatment was initiated at least 14 days before the first dose of DF6215
  • Previous malignant disease (other than the target malignancy to be investigated in this study) within the last 3 years, with the exception of basal or squamous cell carcinoma of the skin, low-grade prostate cancer (Gleason score ≤ 6 and must be Stage I or II), or cervical carcinoma in situ
  • Life expectancy of less than 3 months
  • Patients with brain metastases are excluded, unless all of the following criteria are met:

    • Central nervous system (CNS) lesions are asymptomatic and previously treated
    • Patient does not require ongoing daily steroid treatment for replacement for adrenal insufficiency (except ≤ 10 mg prednisone [or equivalent])
    • Imaging demonstrates stable disease 28 days after last treatment
  • Receipt of any organ transplant, including autologous or allogeneic stem-cell transplantation
  • Pregnancy or lactation during the study

Inclusion

  • You have had treatment, but your cancer has come back.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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