Informations générales (source: ClinicalTrials.gov)
A Phase 1/1b, 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
Interventional
Phase 1
Dragonfly Therapeutics (Voir sur ClinicalTrials)
juillet 2020
novembre 2027
05 avril 2025
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Hospitalier Lyon-Sud - 69495 - Pierre-Benite - France | Contact (sur clinicalTrials) | ||||
| Hôpital Saint-Louis - 75010 - Paris - France | Contact (sur clinicalTrials) | ||||
| Institut Bergonié - 33000 - Bordeaux Cedex - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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
- 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
- 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