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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
170
Number of participants with dose-limiting toxicities (DLTs)
Dose Escalation
Time frame: 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
Time frame: Up to 2 years
Amount of Treatment Emergent Adverse Events (TEAEs)
Number of participants with TEAEs
Time frame: Up to 2 years
Severity of TEAEs
Severity of the TEAEs seen in study participants
Time frame: Up to 2 years
Duration of TEAEs
How long the TEAEs seen last
Time frame: Up to 2 years
Number of participants with changes from baseline in clinical laboratory parameters
Overall change, if any, after treatment
Time frame: Up to 2 years
Number of participants with changes from baseline in electrocardiogram (ECG) parameters
Overall change, if any, after treatment
Time frame: Up to 2 years
Number of participants with changes from baseline in vital sign parameters
Overall change, if any, after treatment
Time frame: Up to 2 years
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University of California Irvine
Orange, California, United States
SCRI - HealthOne Denver
Denver, Colorado, United States
Yale School of Medicine
New Haven, Connecticut, United States
University of Miami
Miami, Florida, United States
Augusta University Georgia Cancer Center
Augusta, Georgia, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Local Institution
Boston, Massachusetts, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
HealthPartners Cancer Center at Regions Hospital
Saint Paul, Minnesota, United States
...and 22 more locations
Duration of Response (DOR) according to RECIST 1.1 per Investigator assessment
Overall change, if any, after treatment
Time frame: 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
Time frame: 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
Time frame: Up to day 28
Maximum serum concentration observed post-dose (Cmax)
Overall change, if any, after treatment
Time frame: Up to day 28
Best overall response (BOR) according to RECIST 1.1 per Investigator assessment
Overall change, if any, after treatment
Time frame: Approximately one year
Clinical benefit rate (CBR) according to RECIST 1.1 per Investigator assessment
Overall change, if any, after treatment
Time frame: Up to 2 years
Confirmed ORR per RECIST 1.1 per Investigator assessment
Phase 1/1b only
Time frame: Up to 2 years
Progression-free survival (PFS) according to RECIST 1.1 per Investigator assessment
Phase 2 only
Time frame: Up to 2 years
CBR according to RECIST 1.1 per IERC
Phase 2 only
Time frame: Up to 2 years
PFS according to RECIST 1.1 per IERC
Phase 2 only
Time frame: Up to 2 years
DOR according to RECIST 1.1 per IERC
Phase 2 only
Time frame: Up to month 24
Unconfirmed response after 4 cycles according to RECIST 1.1
Phase 2 only
Time frame: Up to 2 years
Overall Survival (OS)
Phase 2 only
Time frame: Up to 5 years
Serum titers of anti-DF6002 antibodies
Phase 2 only
Time frame: Up to 2 years
Serum titers of anti-nivolumab antibodies
Phase 2 only
Time frame: Up to 2 years