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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-510511-19 | EudraCT Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation / Monotherapy / Subcutaneously or Intravenously | Experimental | Subcutaneous portion of the study is complete. Dosing DF6002 Q4W |
|
| Dose Escalation / Combination / Subcutaneously or Intravenously | Experimental | Subcutaneous portion of the study is complete. Dosing DF6002 Q4W Dosing nivolumab Q4W |
|
| Safety/PK/PD / Monotherapy / Subcutaneously or Intravenously | Experimental | Subcutaneous portion of the study is complete. Dosing DF6002 Q4W |
|
| Safety/PK/PD / Combination / Subcutaneously or Intravenously | Experimental | Subcutaneous portion of the study is complete. Dosing DF6002 Q4W Dosing nivolumab Q4W |
|
| Efficacy Expansion / Combination / Subcutaneously or Intravenously / Melanoma | Experimental | Subcutaneous portion of the study is complete. 2L+ melanoma Dosing DF6002 Q4W Dosing nivolumab Q4W |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DF6002 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with dose-limiting toxicities (DLTs) | Dose Escalation | During the first 3 weeks of treatment |
| Overall Response Rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per an Independent Endpoint Review Committee (IERC) | Efficacy Expansion Arms | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of Treatment Emergent Adverse Events (TEAEs) | Number of participants with TEAEs | Up to 2 years |
| Severity of TEAEs | Severity of the TEAEs seen in study participants |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Dragonfly Therapeutics | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Irvine | Orange | California | 92868 | United States | ||
| SCRI - HealthOne Denver |
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| Efficacy Expansion / Combination / Subcutaneously or Intravenously / Non-Melanoma | Experimental | Subcutaneous portion of the study is complete. 2L+ non-melanoma skin cancer (including cSCC, BCC, and MCC) Dosing DF6002 Q4W Dosing nivolumab Q4W |
|
| Nivolumab | Drug | Specified dose on specified days |
|
|
| Up to 2 years |
| Duration of TEAEs | How long the TEAEs seen last | Up to 2 years |
| Number of participants with changes from baseline in clinical laboratory parameters | Overall change, if any, after treatment | Up to 2 years |
| Number of participants with changes from baseline in electrocardiogram (ECG) parameters | Overall change, if any, after treatment | Up to 2 years |
| Number of participants with changes from baseline in vital sign parameters | Overall change, if any, after treatment | Up to 2 years |
| Duration of Response (DOR) according to RECIST 1.1 per Investigator assessment | Overall change, if any, after treatment | Up to month 24 |
| Area under the plasma concentration-time curve from the time of dosing to the time of the last observation (AUC 0-T) | Overall change, if any, after treatment | Up to day 28 |
| Area under the plasma concentration-time curve from the time of dosing extrapolated to infinity (AUC 0-INF) | Overall change, if any, after treatment | Up to day 28 |
| Maximum serum concentration observed post-dose (Cmax) | Overall change, if any, after treatment | Up to day 28 |
| Best overall response (BOR) according to RECIST 1.1 per Investigator assessment | Overall change, if any, after treatment | Approximately one year |
| Clinical benefit rate (CBR) according to RECIST 1.1 per Investigator assessment | Overall change, if any, after treatment | Up to 2 years |
| Confirmed ORR per RECIST 1.1 per Investigator assessment | Phase 1/1b only | Up to 2 years |
| Progression-free survival (PFS) according to RECIST 1.1 per Investigator assessment | Phase 2 only | Up to 2 years |
| CBR according to RECIST 1.1 per IERC | Phase 2 only | Up to 2 years |
| PFS according to RECIST 1.1 per IERC | Phase 2 only | Up to 2 years |
| DOR according to RECIST 1.1 per IERC | Phase 2 only | Up to month 24 |
| Unconfirmed response after 4 cycles according to RECIST 1.1 | Phase 2 only | Up to 2 years |
| Overall Survival (OS) | Phase 2 only | Up to 5 years |
| Serum titers of anti-DF6002 antibodies | Phase 2 only | Up to 2 years |
| Serum titers of anti-nivolumab antibodies | Phase 2 only | Up to 2 years |
| Denver |
| Colorado |
| 80218 |
| United States |
| Yale School of Medicine | New Haven | Connecticut | 06520 | United States |
| University of Miami | Miami | Florida | 33136 | United States |
| Augusta University Georgia Cancer Center | Augusta | Georgia | 30912-0003 | United States |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| Local Institution | Boston | Massachusetts | 02215 | United States |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| HealthPartners Cancer Center at Regions Hospital | Saint Paul | Minnesota | 55101 | United States |
| Atlantic Health System | Morristown | New Jersey | 07960 | United States |
| Roswell Park Comprehensive Cancer Center | Buffalo | New York | 14263 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| Stephenson Cancer Center | Oklahoma City | Oklahoma | 73104 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| SCRI - Tennessee Oncology - Saint Thomas West Clinic | Nashville | Tennessee | 37205 | United States |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Huntsman Cancer Institute and Hospital | Salt Lake City | Utah | 84112 | United States |
| USOR - Virginia Cancer Specialists - Fairfax Office | Fairfax | Virginia | 22031 | United States |
| Froedtert Hospital | Milwaukee | Wisconsin | 53226 | United States |
| Local Institution - 0023 | Box Hill | 3128 | Australia |
| Local Institution - 0022 | Heidelberg | 3084 | Australia |
| Institut Bergonié | Bordeaux | 33000 | France |
| Hôpital Saint-Louis | Paris | 75010 | France |
| Centre Hospitalier Lyon-Sud | Pierre-Bénite | 69495 | France |
| Gustave Roussy | Villejuif | 94805 | France |
| Hospital Universitari Vall d'Hebrón | Barcelona | 08035 | Spain |
| Clinica Universidad de Navarra - Madrid | Madrid | 28027 | Spain |
| Hospital Universitario Ramón y Cajal | Madrid | 28034 | Spain |
| START Madrid - Hospital Universitario Fundación Jiménez Díaz | Madrid | 28040 | Spain |
| Clinica Universidad de Navarra - Pamplona | Pamplona | 31008 | Spain |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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