Trial Title:
Study of DF6215 in Patients With Advanced Solid Tumors
NCT ID:
NCT06108479
Condition:
Solid Tumor, Adult
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
DF6215-001
DF6215
Immunotherapy
Melanoma
HPV-Positive Advanced Malignancies
Ovarian Cancer
Head and Neck Cancer
Non-Small Cell Lung Cancer
Renal Cell Carcinoma
Advanced or Metastatic Solid Tumors
Antineoplastic Agents
Antineoplastic Agents, Immunological
Molecular Mechanisms of Pharmacological Action
Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
DF6215
Description:
Immunotherapy (cytokine) targeting effector cells.
Arm group label:
DF6215 Dose Escalation
Arm group label:
DF6215 Expansion in Advanced Melanoma
Arm group label:
DF6215 Safety/PK/PD
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. The study will occur in two
phases. The first phase will be a dose escalation phase, enrolling patients with various
types of solid tumors. 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 tumor.
Criteria for eligibility:
Criteria:
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
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Sarcoma Oncology Center
Address:
City:
Santa Monica
Zip:
90403
Country:
United States
Status:
Recruiting
Contact:
Last name:
Sant Chawla, M.D.
Facility:
Name:
Tampa General Hospital
Address:
City:
Tampa
Zip:
33578
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mayer Fishman, M.D., PhD
Facility:
Name:
Rhode Island Hospital
Address:
City:
Providence
Zip:
02903
Country:
United States
Status:
Recruiting
Contact:
Last name:
Benedito Carneiro, M.D.
Facility:
Name:
SCRI Oncology Partners
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Contact:
Last name:
Meredith McKean, M.D., MPH
Facility:
Name:
Peninsula & South Eastern Haematology and Oncology Group
Address:
City:
Frankston
Zip:
3199
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Vinod Ganju
Facility:
Name:
Institut Paoli-Calmettes
Address:
City:
Marseille
Zip:
13009
Country:
France
Status:
Recruiting
Contact:
Last name:
Cecile Vicier, M.D.
Start date:
November 28, 2023
Completion date:
December 2027
Lead sponsor:
Agency:
Dragonfly Therapeutics
Agency class:
Industry
Source:
Dragonfly Therapeutics
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06108479
