Brief Title: Dose Escalation of DF6002 in Patients With Advanced Solid Tumors, and Expansion in Selected Indications

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Number of participants with dose-limiting toxicities (DLTs)

Primary Outcome 1 - Timeframe: During the first 3 weeks of treatment

Primary Outcome 2 - Measure: Overall Response Rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per an Independent Endpoint Review Committee (IERC)

Primary Outcome 2 - Timeframe: Up to 2 years

CONDITION

• Solid Tumors

ELIGIBILITY

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Clinical Trials

Role: Study Chair

Affiliation: Dragonfly Therapeutics

Overall Contact

Name: Clinical Trials

Phone: 617-588-0086

Email: [email protected]

LOCATION