A Study of DF6002 Alone and in Combination With Nivolumab

Dragonfly Therapeutics

Status and phase: Enrolling; Phase 1

Conditions: Solid Tumors

Treatments: Drug: Nivolumab; Drug: DF6002

Study type: Interventional

Funder types: Industry

Identifiers

NCT04423029

DF6002 - 001

2023-510511-19 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 438 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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438 participants in 6 patient groups

Dose Escalation / Monotherapy / Subcutaneously or Intravenously

Experimental group

Description:

Subcutaneous portion of the study is complete. Dosing DF6002 Q4W

Treatment:

Drug: DF6002

Dose Escalation / Combination / Subcutaneously or Intravenously

Experimental group

Description:

Subcutaneous portion of the study is complete. Dosing DF6002 Q4W Dosing nivolumab Q4W

Treatment:

Drug: DF6002

Drug: Nivolumab

Safety/PK/PD / Monotherapy / Subcutaneously or Intravenously

Experimental group

Description:

Subcutaneous portion of the study is complete. Dosing DF6002 Q4W

Treatment:

Drug: DF6002

Safety/PK/PD / Combination / Subcutaneously or Intravenously

Experimental group

Description:

Subcutaneous portion of the study is complete. Dosing DF6002 Q4W Dosing nivolumab Q4W

Treatment:

Drug: DF6002

Drug: Nivolumab

Efficacy Expansion / Combination / Subcutaneously or Intravenously / Melanoma

Experimental group

Description:

Subcutaneous portion of the study is complete. 2L+ melanoma Dosing DF6002 Q4W Dosing nivolumab Q4W

Treatment:

Drug: DF6002

Drug: Nivolumab

Efficacy Expansion / Combination / Subcutaneously or Intravenously / Non-Melanoma

Experimental group

Description:

Subcutaneous portion of the study is complete. 2L+ non-melanoma skin cancer (including cSCC, BCC, and MCC) Dosing DF6002 Q4W Dosing nivolumab Q4W

Treatment:

Drug: DF6002

Drug: Nivolumab