The primary objective of this study is to identify the recommended phase 2 dose (RP2D) and/or the maximum tolerated dose (MTD), and characterize the safety and tolerability of ADCT-601 monotherapy and in combination with gemcitabine.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
128
Intravenous (IV) infusion
Intravenous (IV) infusion
Sarcoma Oncology Research Center
Santa Monica, California, United States
Stanford Cancer Center, Stanford Medicine at Stanford University
Stanford, California, United States
Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs)
Adverse events (AEs) and serious adverse events (SAEs) are 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 years
Number of Participants who Experience a Dose Limiting Toxicity (DLT)
Time frame: Day 1 to Day 21
Number of Participants who Experience a Dose Interruption
Time frame: Up to approximately 2 years
Number of Participants who Experience a Dose Reduction
Time frame: Up to approximately 2 years
Overall Response Rate (ORR)
Time frame: Up to approximately 2 years
Duration of Response (DOR)
Time frame: Up to approximately 2 years
Progression-Free Survival (PFS)
Time frame: Up to approximately 2 years
Overall Survival (OS)
Time frame: Up to approximately 2 years
Serum Concentration of ADCT-601 Total Antibody, Pyrrolobenzodiazepine (PBD)-Conjugated Antibody, and Unconjugated Warhead SG3199
Time frame: Day 1 up to approximately 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of IOWA
Iowa City, Iowa, United States
Washington University School of Medicine
St Louis, Missouri, United States
Sarah Cannon at University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Vanderbilt University Medical Center (VUMC) - Ingram Cancer Center
Nashville, Tennessee, United States
Institut Bergonié
Bordeaux, Gironde, France
Institut Léon Bérard
Lyon, France
Centre Antoine Lacassagne
Nice, France
Hospital Universitario Vall d'Hebron
Barcelona, Spain
...and 4 more locations
Maximum Concentration (Cmax) of ADCT-601 Total Antibody, Pyrrolobenzodiazepine (PBD)-Conjugated Antibody, and Unconjugated Warhead SG3199 in Serum
Time frame: Day 1 up to approximately 2 years
Time to Maximum Concentration (Tmax) of ADCT-601 Total Antibody, Pyrrolobenzodiazepine (PBD)-Conjugated Antibody, and Unconjugated Warhead SG3199 in Serum
Time frame: Day 1 up to approximately 2 years
Area Under the Concentration-time Curve from Time Zero to the Last Quantifiable Concentration (AUClast) of ADCT-601 Total Antibody, Pyrrolobenzodiazepine (PBD)-Conjugated Antibody, and Unconjugated Warhead SG3199 in Serum
Time frame: Day 1 up to approximately 2 years
Area Under the Concentration-time Curve from Time Zero to the End of the Dosing Interval (AUCtau) of ADCT-601 Total Antibody, Pyrrolobenzodiazepine (PBD)-Conjugated Antibody, and Unconjugated Warhead SG3199 in Serum
Time frame: Day 1 up to approximately 2 years
Area Under the Concentration-time Curve from Time Zero to Infinity (AUCinf) of ADCT-601 Total Antibody, Pyrrolobenzodiazepine (PBD)-Conjugated Antibody, and Unconjugated Warhead SG3199 in Serum
Time frame: Day 1 up to approximately 2 years
Apparent Terminal Elimination Half-life (T1/2) of ADCT-601 Total Antibody, Pyrrolobenzodiazepine (PBD)-Conjugated Antibody, and Unconjugated Warhead SG3199 in Serum
Time frame: Day 1 up to approximately 2 years
Apparent Clearance (CL) of ADCT-601 Total Antibody, Pyrrolobenzodiazepine (PBD)-Conjugated Antibody, and Unconjugated Warhead SG3199 in Serum
Time frame: Day 1 up to approximately 2 years
Apparent Steady-state Volume of Distribution (Vss) of ADCT-601 Total Antibody, Pyrrolobenzodiazepine (PBD)-Conjugated Antibody, and Unconjugated Warhead SG3199 in Serum
Time frame: Day 1 up to approximately 2 years
Accumulation Index (AI) of ADCT-601 Total Antibody, Pyrrolobenzodiazepine (PBD)-Conjugated Antibody, and Unconjugated Warhead SG3199 in Serum
Time frame: Day 1 up to approximately 2 years
Number of Participants With an Anti-drug Antibody (ADA) Response to ADCT-601
Time frame: Day 1 up to approximately 2 years
Number of Participants With Anti-drug Antibody (ADA) Titers to ADCT-601
Time frame: Day 1 up to approximately 2 years