The primary objectives of this study are to identify the recommended phase 2 dose (RP2D) and/or maximum tolerated dose (MTD), and to characterize the safety and the tolerability of ADCT-901.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Intravenous infusion
Sarah Cannon at HealthONE
Denver, Colorado, United States
Yale Cancer Center
New Haven, Connecticut, United States
Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs)
Adverse events (AEs) and serious adverse events (SAEs) were defined as any untoward medical occurrence in participants whether or not considered related to the investigational medicinal product. Any clinically significant changes in vital signs, laboratory values, 12-lead electrocardiogram (ECG) and Eastern Cooperative Oncology Group (ECOG) performance status results will be recorded as AEs and SAEs.
Time frame: Up to approximately 2.5 years
Number of Participants Who Experience a Dose Limiting Toxicity (DLT) During the Dose-Escalation Phase
Time frame: Day 1 to Day 21
Number of Participants Who Experience a Dose Interruption
Time frame: Up to approximately 2.5 years
Number of Participants Who Experience a Dose Reduction
Time frame: Up to approximately 2.5 years
Overall Response Rate (ORR)
Time frame: Up to approximately 2.5 years
Duration of Response (DOR)
Time frame: Up to approximately 2.5 years
Progression-Free Survival (PFS)
Time frame: Up to approximately 2.5 years
Overall Survival (OS)
Time frame: Up to approximately 2.5 years
Maximum Concentration (Cmax) of ADCT-901 Total Antibody, Pyrrolobenzodiazepine (PBD)-Conjugated Antibody, and Unconjugated Warhead SG3199 in Serum
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Emory University, Winship Cancer Institute
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
University Hospitals of Cleveland Medical Center (UHCMC)
Cleveland, Ohio, United States
Sarah Cannon at University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
NEXT Oncology
San Antonio, Texas, United States
Institut Catala D'oncologia (ICO) - Hospital Duran I Reynals Location
Badalona, Barcelona, Spain
Hospital Universitari Vall D'hebron - Vall D'hebron Institut D'oncologia (VHIO)
Barcelona, Spain
(START) Madrid - Hospital Universitario Fundación Jiménez Díaz Location
Madrid, Spain
...and 3 more locations
Time frame: Up to approximately 2.5 years
Time to Maximum Concentration (Tmax) of ADCT-901 Total Antibody, Pyrrolobenzodiazepine (PBD)-Conjugated Antibody, and Unconjugated Warhead SG3199 in Serum
Time frame: Up to approximately 2.5 years
Area Under the Concentration-Time Curve From Time Zero to the End of the Dosing Interval (AUClast) of ADCT-901 Total Antibody, Pyrrolobenzodiazepine (PBD)-Conjugated Antibody, and Unconjugated Warhead SG3199 in Serum
Time frame: Up to approximately 2.5 years
Area Under the Concentration-Time Curve From Time Zero to the End of the Dosing Interval (AUCtau) of ADCT-901 Total Antibody, Pyrrolobenzodiazepine (PBD)-Conjugated Antibody, and Unconjugated Warhead SG3199 in Serum
Time frame: Up to approximately 2.5 years
Area Under the Concentration-Time Curve From Time Zero to Infinity (AUCinf) of ADCT-901 Total Antibody, Pyrrolobenzodiazepine (PBD)-Conjugated Antibody, and Unconjugated Warhead SG3199 in Serum
Time frame: Up to approximately 2.5 years
Apparent Terminal Elimination Half-Life (Thalf) of ADCT-901 Total Antibody, Pyrrolobenzodiazepine (PBD)-Conjugated Antibody, and Unconjugated Warhead SG3199 in Serum
Time frame: Up to approximately 2.5 years
Apparent Clearance (CL) of ADCT-901 Total Antibody, Pyrrolobenzodiazepine (PBD)-Conjugated Antibody, and Unconjugated Warhead SG3199 in Serum
Time frame: Up to approximately 2.5 years
Apparent Volume of Distribution (Vss) of ADCT-901 Total Antibody, Pyrrolobenzodiazepine (PBD)-Conjugated Antibody, and Unconjugated Warhead SG3199 in Serum
Time frame: Up to approximately 2.5 years
Accumulation Index (AI) of ADCT-901 Total Antibody, Pyrrolobenzodiazepine (PBD)-Conjugated Antibody, and Unconjugated Warhead SG3199 in Serum
Time frame: Up to approximately 2.5 years
Number of Participants with an Anti-drug Antibody (ADA) Response to ADCT-901
Time frame: Up to approximately 2.5 years