A Study of DF6002 Alone and in Combination With Nivolumab

Dragonfly Therapeutics

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Solid Tumors

Treatments: Drug: Nivolumab; Drug: DF6002

Study type: Interventional

Funder types: Industry

Identifiers

NCT04423029

CA101-001

2021-000038-33 (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.

Enrollment: 473 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
• 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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473 participants in 6 patient groups

Monotherapy Dose Escalation

Experimental group

Treatment:

Drug: DF6002

Monotherapy Dose Expansion (Melanoma)

Experimental group

Treatment:

Drug: DF6002

Monotherapy Dose Expansion (NSCLC)

Experimental group

Treatment:

Drug: DF6002

Combination Dose Escalation

Experimental group

Treatment:

Drug: Nivolumab

Drug: DF6002

Combination Dose Expansion (Melanoma)

Experimental group

Treatment:

Drug: Nivolumab

Drug: DF6002

Combination Dose Expansion (NSCLC)

Experimental group

Treatment:

Drug: Nivolumab

Drug: DF6002