A Study of DF6002 Alone and in Combination With Nivolumab
PHASE1COMPLETED
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.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
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
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- PHASE1
Study ID
NCT04423029
Intervention or treatment
DRUG: DF6002
DRUG: Nivolumab
Conditions
- Solid Tumors
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Research sites nearby
Closest Location:
Local Institution - 0023
Select from list below to view details:
Local Institution - 0023
Box Hill, Australia
Local Institution - 0022
Heidelberg, Australia
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Who is running the clinical trial?
DT
Dragonfly Therapeutics
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Dose Escalation / Monotherapy / Subcutaneously or Intravenously
| Drug: DF6002 |
EXPERIMENTAL: Dose Escalation / Combination / Subcutaneously or Intravenously
| Drug: DF6002, Drug: Nivolumab |
EXPERIMENTAL: Safety/PK/PD / Monotherapy / Subcutaneously or Intravenously
| Drug: DF6002 |
EXPERIMENTAL: Safety/PK/PD / Combination / Subcutaneously or Intravenously
| Drug: DF6002, Drug: Nivolumab |
EXPERIMENTAL: Efficacy Expansion / Combination / Subcutaneously or Intravenously / Melanoma
| Drug: DF6002, Drug: Nivolumab |
EXPERIMENTAL: Efficacy Expansion / Combination / Subcutaneously or Intravenously / Non-Melanoma
| Drug: DF6002, Drug: Nivolumab |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with dose-limiting toxicities (DLTs) | Dose Escalation | During the first 3 weeks of treatment |
| Overall Response Rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per an Independent Endpoint Review Committee (IERC) | Efficacy Expansion Arms | Up to 2 years |
Secondary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Amount of Treatment Emergent Adverse Events (TEAEs) | Number of participants with TEAEs | Up to 2 years |
| Severity of TEAEs | Severity of the TEAEs seen in study participants | Up to 2 years |
| Duration of TEAEs | How long the TEAEs seen last | Up to 2 years |
| Number of participants with changes from baseline in clinical laboratory parameters | Overall change, if any, after treatment | Up to 2 years |
| Number of participants with changes from baseline in electrocardiogram (ECG) parameters | Overall change, if any, after treatment | Up to 2 years |
| Number of participants with changes from baseline in vital sign parameters | Overall change, if any, after treatment | Up to 2 years |
| Duration of Response (DOR) according to RECIST 1.1 per Investigator assessment | Overall change, if any, after treatment | Up to month 24 |
| Area under the plasma concentration-time curve from the time of dosing to the time of the last observation (AUC 0-T) | Overall change, if any, after treatment | Up to day 28 |
| Area under the plasma concentration-time curve from the time of dosing extrapolated to infinity (AUC 0-INF) | Overall change, if any, after treatment | Up to day 28 |
| Maximum serum concentration observed post-dose (Cmax) | Overall change, if any, after treatment | Up to day 28 |
| Best overall response (BOR) according to RECIST 1.1 per Investigator assessment | Overall change, if any, after treatment | Approximately one year |
| Clinical benefit rate (CBR) according to RECIST 1.1 per Investigator assessment | Overall change, if any, after treatment | Up to 2 years |
| Confirmed ORR per RECIST 1.1 per Investigator assessment | Phase 1/1b only | Up to 2 years |
| Progression-free survival (PFS) according to RECIST 1.1 per Investigator assessment | Phase 2 only | Up to 2 years |
| CBR according to RECIST 1.1 per IERC | Phase 2 only | Up to 2 years |
| PFS according to RECIST 1.1 per IERC | Phase 2 only | Up to 2 years |
| DOR according to RECIST 1.1 per IERC | Phase 2 only | Up to month 24 |
| Unconfirmed response after 4 cycles according to RECIST 1.1 | Phase 2 only | Up to 2 years |
| Overall Survival (OS) | Phase 2 only | Up to 5 years |
| Serum titers of anti-DF6002 antibodies | Phase 2 only | Up to 2 years |
| Serum titers of anti-nivolumab antibodies | Phase 2 only | Up to 2 years |
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References
Clinical Trials Gov: A Study of DF6002 Alone and in Combination With NivolumabOther trials to consider
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