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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04423029




Registration number
NCT04423029
Ethics application status
Date submitted
5/06/2020
Date registered
9/06/2020
Date last updated
20/04/2023

Titles & IDs
Public title
A Study of DF6002 Alone and in Combination With Nivolumab
Scientific title
A Phase 1/2, First-In-Human, Multi-Part, Open-Label, Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological, and Clinical Activity of DF6002 as a Monotherapy and in Combination With Nivolumab in Patients With Locally Advanced or Metastatic Solid Tumors, and Expansion in Selected Indications
Secondary ID [1] 0 0
2021-000038-33
Secondary ID [2] 0 0
CA101-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - DF6002
Treatment: Drugs - Nivolumab

Experimental: Monotherapy Dose Escalation -

Experimental: Monotherapy Dose Expansion (Melanoma) -

Experimental: Monotherapy Dose Expansion (NSCLC) -

Experimental: Combination Dose Escalation -

Experimental: Combination Dose Expansion (Melanoma) -

Experimental: Combination Dose Expansion (NSCLC) -


Treatment: Drugs: DF6002
Specified dose on specified days

Treatment: Drugs: Nivolumab
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with dose-limiting toxicities (DLTs)
Timepoint [1] 0 0
During the first 3 weeks of treatment
Primary outcome [2] 0 0
Overall Response Rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per an Independent Endpoint Review Committee (IERC)
Timepoint [2] 0 0
Up to 2 years
Secondary outcome [1] 0 0
Number of participants with treatment emergent adverse events (TEAEs)
Timepoint [1] 0 0
Up to 2 years
Secondary outcome [2] 0 0
Severity of TEAEs
Timepoint [2] 0 0
Up to 2 years
Secondary outcome [3] 0 0
Duration of TEAEs
Timepoint [3] 0 0
Up to 2 years
Secondary outcome [4] 0 0
Number of participants with changes from baseline in clinical laboratory parameters
Timepoint [4] 0 0
Up to 2 years
Secondary outcome [5] 0 0
Number of participants with changes from baseline in electrocardiogram (ECG) parameters
Timepoint [5] 0 0
Up to 2 years
Secondary outcome [6] 0 0
Number of participants with changes from baseline in vital sign parameters
Timepoint [6] 0 0
Up to 2 years
Secondary outcome [7] 0 0
Number of participants with changes from baseline in Eastern Cooperative Oncology Group (ECOG) performance status
Timepoint [7] 0 0
Up to 2 years
Secondary outcome [8] 0 0
Duration of Response (DOR) according to RECIST 1.1 per Investigator assessment
Timepoint [8] 0 0
Up to month 24
Secondary outcome [9] 0 0
Area under the plasma concentration-time curve from the time of dosing to the time of the last observation (AUC 0-T)
Timepoint [9] 0 0
Up to day 28
Secondary outcome [10] 0 0
Area under the plasma concentration-time curve from the time of dosing extrapolated to infinity (AUC 0-INF)
Timepoint [10] 0 0
Up to day 28
Secondary outcome [11] 0 0
Maximum serum concentration observed post-dose (Cmax)
Timepoint [11] 0 0
Up to day 28
Secondary outcome [12] 0 0
Best overall response (BOR) according to RECIST 1.1 per Investigator assessment
Timepoint [12] 0 0
Approximately one year
Secondary outcome [13] 0 0
Clinical benefit rate (CBR) according to RECIST 1.1 per Investigator assessment
Timepoint [13] 0 0
Up to 2 years
Secondary outcome [14] 0 0
Confirmed ORR per RECIST 1.1 per Investigator assessment
Timepoint [14] 0 0
Up to 2 years
Secondary outcome [15] 0 0
Progression-free survival (PFS) according to RECIST 1.1 per Investigator assessment
Timepoint [15] 0 0
Up to 2 years
Secondary outcome [16] 0 0
CBR according to RECIST 1.1 per IERC
Timepoint [16] 0 0
Up to 2 years
Secondary outcome [17] 0 0
PFS according to RECIST 1.1 per IERC
Timepoint [17] 0 0
Up to 2 years
Secondary outcome [18] 0 0
DOR according to RECIST 1.1 per IERC
Timepoint [18] 0 0
Up to month 24
Secondary outcome [19] 0 0
Unconfirmed response after 4 cycles according to RECIST 1.1
Timepoint [19] 0 0
Up to 2 years
Secondary outcome [20] 0 0
Overall Survival (OS)
Timepoint [20] 0 0
Up to 5 years
Secondary outcome [21] 0 0
Serum titers of anti-DF6002 antibodies
Timepoint [21] 0 0
Up to 2 years
Secondary outcome [22] 0 0
Serum titers of anti-nivolumab antibodies
Timepoint [22] 0 0
Up to 2 years

Eligibility
Key inclusion criteria
* Advanced/metastatic solid tumors, for which no standard therapy exists or standard therapy has failed among the following tumor types: melanoma, non-small cell lung cancer, small cell lung cancer, head and neck squamous cell, urothelial, gastric, esophageal, cervical, hepatocellular, merkel cell, cutaneous squamous cell carcinoma, renal cell, endometrial, triple-negative breast, ovarian, and prostate
* ECOG performance status of 0 or 1
* Clinical or radiological evidence of disease
* Adequate hematological, hepatic and renal function
* Anticoagulants are required for the following: Khorana Risk Score = 2 or as assessed by Investigator as being at high risk for venous thromboembolism (VTE) or history of VTE = 6 months from enrollment
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Concurrent anticancer treatment (with the exception of 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 study treatment
* Previous malignant disease other than the current target malignancy within the last 3 years, with the exception of basal or squamous cell carcinoma of the skin, localized prostate cancer or cervical carcinoma in situ
* Rapidly progressive disease
* Serious cardiac illness or medical conditions
* Known diagnosis of antiphospholipid syndrome or clinically significant hereditary thrombophilia

Other protocol-defined inclusion/exclusion criteria apply

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
Parallel
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
13/07/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
16/12/2025
Actual
Sample size
Target
473
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Local Institution - 0023 - Box Hill
Recruitment hospital [2] 0 0
Local Institution - 0022 - Heidelberg
Recruitment postcode(s) [1] 0 0
3128 - Box Hill
Recruitment postcode(s) [2] 0 0
3084 - Heidelberg
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
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Iowa
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Minnesota
Country [10] 0 0
United States of America
State/province [10] 0 0
New Jersey
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
Ohio
Country [13] 0 0
United States of America
State/province [13] 0 0
Oklahoma
Country [14] 0 0
United States of America
State/province [14] 0 0
Rhode Island
Country [15] 0 0
United States of America
State/province [15] 0 0
Tennessee
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
United States of America
State/province [17] 0 0
Utah
Country [18] 0 0
United States of America
State/province [18] 0 0
Virginia
Country [19] 0 0
United States of America
State/province [19] 0 0
Wisconsin
Country [20] 0 0
France
State/province [20] 0 0
Ile-de-France
Country [21] 0 0
France
State/province [21] 0 0
Rhone
Country [22] 0 0
France
State/province [22] 0 0
Bordeaux Cedex
Country [23] 0 0
France
State/province [23] 0 0
Paris
Country [24] 0 0
France
State/province [24] 0 0
Pierre-Benite
Country [25] 0 0
France
State/province [25] 0 0
Villejuif
Country [26] 0 0
Spain
State/province [26] 0 0
Navarre
Country [27] 0 0
Spain
State/province [27] 0 0
Barcelona
Country [28] 0 0
Spain
State/province [28] 0 0
Madrid
Country [29] 0 0
Spain
State/province [29] 0 0
Pamplona

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
Jean-Marie Cuillerot, MD
Address 0 0
Chief Medical Officer
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

No information has been provided regarding IPD availability


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/NCT04423029