Solid Tumors
Conditions
Keywords
Advanced or Metastatic Solid Tumors, Melanoma, Non-small Cell Lung Cancer, Nivolumab, DF6002
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.
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.
Interventions
DRUGDF6002
Specified dose on specified days
DRUGNivolumab
Specified dose on specified days
Sponsors
Dragonfly Therapeutics
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with dose-limiting toxicities (DLTs) | During the first 3 weeks of treatment | Dose Escalation |
| Overall Response Rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per an Independent Endpoint Review Committee (IERC) | Up to 2 years | Efficacy Expansion Arms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Amount of Treatment Emergent Adverse Events (TEAEs) | Up to 2 years | Number of participants with TEAEs |
| Severity of TEAEs | Up to 2 years | Severity of the TEAEs seen in study participants |
| Duration of TEAEs | Up to 2 years | How long the TEAEs seen last |
| Number of participants with changes from baseline in clinical laboratory parameters | Up to 2 years | Overall change, if any, after treatment |
| Number of participants with changes from baseline in electrocardiogram (ECG) parameters | Up to 2 years | Overall change, if any, after treatment |
| Number of participants with changes from baseline in vital sign parameters | Up to 2 years | Overall change, if any, after treatment |
| Duration of Response (DOR) according to RECIST 1.1 per Investigator assessment | Up to month 24 | Overall change, if any, after treatment |
| Area under the plasma concentration-time curve from the time of dosing to the time of the last observation (AUC 0-T) | Up to day 28 | Overall change, if any, after treatment |
| Area under the plasma concentration-time curve from the time of dosing extrapolated to infinity (AUC 0-INF) | Up to day 28 | Overall change, if any, after treatment |
| Maximum serum concentration observed post-dose (Cmax) | Up to day 28 | Overall change, if any, after treatment |
| Best overall response (BOR) according to RECIST 1.1 per Investigator assessment | Approximately one year | Overall change, if any, after treatment |
| Clinical benefit rate (CBR) according to RECIST 1.1 per Investigator assessment | Up to 2 years | Overall change, if any, after treatment |
| Confirmed ORR per RECIST 1.1 per Investigator assessment | Up to 2 years | Phase 1/1b only |
| Progression-free survival (PFS) according to RECIST 1.1 per Investigator assessment | Up to 2 years | Phase 2 only |
| CBR according to RECIST 1.1 per IERC | Up to 2 years | Phase 2 only |
| PFS according to RECIST 1.1 per IERC | Up to 2 years | Phase 2 only |
| DOR according to RECIST 1.1 per IERC | Up to month 24 | Phase 2 only |
| Unconfirmed response after 4 cycles according to RECIST 1.1 | Up to 2 years | Phase 2 only |
| Overall Survival (OS) | Up to 5 years | Phase 2 only |
| Serum titers of anti-DF6002 antibodies | Up to 2 years | Phase 2 only |
| Serum titers of anti-nivolumab antibodies | Up to 2 years | Phase 2 only |
Countries
Australia, France, Spain, United States
Contacts
STUDY_CHAIRClinical Trials
Dragonfly Therapeutics
Outcome results
None listed