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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06108479




Registration number
NCT06108479
Ethics application status
Date submitted
25/10/2023
Date registered
31/10/2023

Titles & IDs
Public title
Study of DF6215 in Patients With Advanced Solid Tumors
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
Secondary ID [1] 0 0
DF6215-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Solid Tumor, Adult 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - DF6215

Experimental: DF6215 Dose Escalation - Dose escalation cohorts of DF6215 in sequential ascending order.

Experimental: DF6215 Safety/PK/PD - 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.

Experimental: DF6215 Expansion in Advanced Melanoma - 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.


Treatment: Drugs: DF6215
Immunotherapy (cytokine) targeting effector cells.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Assessment of number of DLTs experienced on study as defined per criteria in the study protocol
Timepoint [1] 0 0
First 4 weeks of treatment for each subject.
Primary outcome [2] 0 0
Assess ORR per RECIST 1.1 criteria
Timepoint [2] 0 0
Through 90 days after completion of the study, an average of 1 year.
Primary outcome [3] 0 0
Assess DOR per RECIST 1.1 criteria
Timepoint [3] 0 0
From time of initiation of therapy until the date of first documented tumor progression, assessed up to 24 months.
Primary outcome [4] 0 0
Assess PFS per RECIST 1.1 criteria
Timepoint [4] 0 0
From time of initiation of therapy until the date of first documented tumor progression, assessed up to 24 months.
Secondary outcome [1] 0 0
Assess number of adverse events observed during treatment with DF6215
Timepoint [1] 0 0
Screening visit up to 30 days after End of Treatment visit.
Secondary outcome [2] 0 0
Evaluation of DF6215 Pharmacokinetics
Timepoint [2] 0 0
From start of treatment up to 28 days after the decision to stop study treatment.
Secondary outcome [3] 0 0
Evaluation of DF6215 Immunogenicity
Timepoint [3] 0 0
From start of treatment up to 28 days after the decision to stop study treatment.

Eligibility
Key inclusion 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/11/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2027
Actual
Sample size
Target
102
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peninsula & South Eastern Haematology and Oncology Group - Frankston
Recruitment postcode(s) [1] 0 0
3199 - Frankston
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Rhode Island
Country [4] 0 0
United States of America
State/province [4] 0 0
Tennessee
Country [5] 0 0
France
State/province [5] 0 0
Marseille

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Dragonfly Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sean Rossi
Address 0 0
Country 0 0
Phone 0 0
617-588-0086
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06108479