A Phase 1/2, First-In-Human, Multi-Part, Open-Label, Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological, and Clinical Activity of DF6002 as a Monotherapy and in Combination with Nivolumab in Patients With Locally Advanced or Metastatic Solid Tumors, and Expansion in Selected Indications
Trial Description
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.
Eligibility Requirements
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