A Study to Assess DF6002 (BMS-986415) Alone and in Combination With Nivolumab in Participants With Locally Advanced or Metastatic Solid Tumors

Brief Summary
The purpose of this study is to evaluate the safety, tolerability, drug-levels, drug-effects and preliminary anti-tumor activity of DF6002 alone and in combination with Nivolumab in participants with advanced solid tumors.
Brief Title
A Study of DF6002 Alone and in Combination With Nivolumab
Detailed Description
Assess the safety and tolerability of subcutaneous (SC) and intravenous (IV) administration of DF6002, as monotherapy and in combination with nivolumab, and to determine the maximum tolerated dose (MTD) and recommended efficacy expansion dose (REED) of SC and IV DF6002, both as monotherapy and in combination with nivolumab, for patients with advanced (unresectable, recurrent, or metastatic) solid tumors.
Central Contacts
Central Contact Role
Contact
Central Contact Phone
617-588-0086
Central Contact Email
clinicaltrials@dragonflytx.com
Completion Date
Completion Date Type
Estimated
Conditions
Solid Tumors
Eligibility Criteria
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

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
* Prior treatment with DF6002, recombinant human interleukin-12 (rhIL-12)-directed therapy, or any drug containing an interleukin-12 (IL-12) moiety
* 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
Inclusion Criteria
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

inclusion/
Gender
All
Gender Based
false
Keywords
Advanced or Metastatic Solid Tumors
Melanoma
Non-small Cell Lung Cancer
Nivolumab
DF6002
Healthy Volunteers
No
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT04423029
Org Class
Industry
Org Full Name
Dragonfly Therapeutics
Org Study Id
DF6002 - 001
Overall Status
Recruiting
Phases
Phase 1
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
A Phase 1/1b, 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
Primary Outcomes
Outcome Description
Dose Escalation
Outcome Measure
Number of participants with dose-limiting toxicities (DLTs)
Outcome Time Frame
During the first 3 weeks of treatment
Outcome Description
Efficacy Expansion Arms
Outcome Measure
Overall Response Rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per an Independent Endpoint Review Committee (IERC)
Outcome Time Frame
Up to 2 years
Secondary Ids
Secondary Id
2023-510511-19
Secondary Outcomes
Outcome Description
Number of participants with TEAEs
Outcome Time Frame
Up to 2 years
Outcome Measure
Amount of Treatment Emergent Adverse Events (TEAEs)
Outcome Description
Severity of the TEAEs seen in study participants
Outcome Time Frame
Up to 2 years
Outcome Measure
Severity of TEAEs
Outcome Description
How long the TEAEs seen last
Outcome Time Frame
Up to 2 years
Outcome Measure
Duration of TEAEs
Outcome Description
Overall change, if any, after treatment
Outcome Time Frame
Up to 2 years
Outcome Measure
Number of participants with changes from baseline in clinical laboratory parameters
Outcome Description
Overall change, if any, after treatment
Outcome Time Frame
Up to 2 years
Outcome Measure
Number of participants with changes from baseline in electrocardiogram (ECG) parameters
Outcome Description
Overall change, if any, after treatment
Outcome Time Frame
Up to 2 years
Outcome Measure
Number of participants with changes from baseline in vital sign parameters
Outcome Description
Overall change, if any, after treatment
Outcome Time Frame
Up to month 24
Outcome Measure
Duration of Response (DOR) according to RECIST 1.1 per Investigator assessment
Outcome Description
Overall change, if any, after treatment
Outcome Time Frame
Up to day 28
Outcome Measure
Area under the plasma concentration-time curve from the time of dosing to the time of the last observation (AUC 0-T)
Outcome Description
Overall change, if any, after treatment
Outcome Time Frame
Up to day 28
Outcome Measure
Area under the plasma concentration-time curve from the time of dosing extrapolated to infinity (AUC 0-INF)
Outcome Description
Overall change, if any, after treatment
Outcome Time Frame
Up to day 28
Outcome Measure
Maximum serum concentration observed post-dose (Cmax)
Outcome Description
Overall change, if any, after treatment
Outcome Time Frame
Approximately one year
Outcome Measure
Best overall response (BOR) according to RECIST 1.1 per Investigator assessment
Outcome Description
Overall change, if any, after treatment
Outcome Time Frame
Up to 2 years
Outcome Measure
Clinical benefit rate (CBR) according to RECIST 1.1 per Investigator assessment
Outcome Description
Phase 1/1b only
Outcome Time Frame
Up to 2 years
Outcome Measure
Confirmed ORR per RECIST 1.1 per Investigator assessment
Outcome Description
Phase 2 only
Outcome Time Frame
Up to 2 years
Outcome Measure
Progression-free survival (PFS) according to RECIST 1.1 per Investigator assessment
Outcome Description
Phase 2 only
Outcome Time Frame
Up to 2 years
Outcome Measure
CBR according to RECIST 1.1 per IERC
Outcome Description
Phase 2 only
Outcome Time Frame
Up to 2 years
Outcome Measure
PFS according to RECIST 1.1 per IERC
Outcome Description
Phase 2 only
Outcome Time Frame
Up to month 24
Outcome Measure
DOR according to RECIST 1.1 per IERC
Outcome Description
Phase 2 only
Outcome Time Frame
Up to 2 years
Outcome Measure
Unconfirmed response after 4 cycles according to RECIST 1.1
Outcome Description
Phase 2 only
Outcome Time Frame
Up to 5 years
Outcome Measure
Overall Survival (OS)
Outcome Description
Phase 2 only
Outcome Time Frame
Up to 2 years
Outcome Measure
Serum titers of anti-DF6002 antibodies
Outcome Description
Phase 2 only
Outcome Time Frame
Up to 2 years
Outcome Measure
Serum titers of anti-nivolumab antibodies
Start Date
Start Date Type
Actual
Status Verified Date
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
David Levitz
Investigator Email
dlevitz@montefiore.org