This is a Phase 1a/1b study of SC-003 as a single agent and in combination with ABBV-181 in patients with platinum-resistant/refractory ovarian cancer. SC-003 is an antibody-drug conjugate (ADC) comprised of a monoclonal antibody linked to a potent chemotherapy. ABBV-181 is a humanized, recombinant, mAb that binds to cell surface expressed programmed cell death 1 (PD-1).
Phase 1a is a dose escalation study in patients with histologically/cytologically confirmed ovarian cancer that are platinum-resistant or refractory. Phase 1b is an expansion study where patients will be enrolled and treated at recommended dose and schedule based on the Phase 1a.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
74
Unnamed facility
Fayetteville, Arkansas, United States
Unnamed facility
Duarte, California, United States
Unnamed facility
Chicago, Illinois, United States
Adverse Events
Time frame: 18 months (Phase 1a/1b)
Overall Response Rate
Time frame: 18 months (Phase 1a/1b)
Pharmacokinetics of SC-003: AUC (area under the curve)
Time frame: Cycle 1 and 4: days 1 (pre-dose, post-dose: 30min, 6hr), 2, 4, 8, 15; Cycles 2, 3, and 5: day 1 (pre-dose, post-dose: 30min)
Pharmacokinetics of SC-003: Cmax (maximum concentration)
Time frame: Cycle 1 and 4: days 1 (pre-dose, post-dose: 30min, 6hr), 2, 4, 8, 15; Cycles 2, 3, and 5: day 1 (pre-dose, post-dose: 30min
Pharmacokinetics of SC-003: Tmax (time of maximum concentration)
Time frame: Cycle 1 and 4: days 1 (pre-dose, post-dose: 30min, 6hr), 2, 4, 8, 15; Cycles 2, 3, and 5: day 1 (pre-dose, post-dose: 30min
Pharmacokinetics of SC-003: Ctrough (concentration at trough)
Time frame: Cycle 1 and 4: days 1 (pre-dose, post-dose: 30min, 6hr), 2, 4, 8, 15; Cycles 2, 3, and 5: day 1 (pre-dose, post-dose: 30min
Pharmacokinetics of SC-003: T1/2 (terminal half life)
Time frame: Cycle 1 and 4: days 1 (pre-dose, post-dose: 30min, 6hr), 2, 4, 8, 15; Cycles 2, 3, and 5: day 1 (pre-dose, post-dose: 30min
Pharmacokinetics of SC-003: CL (clearance)
Time frame: Cycle 1 and 4: days 1 (pre-dose, post-dose: 30min, 6hr), 2, 4, 8, 15; Cycles 2, 3, and 5: day 1 (pre-dose, post-dose: 30min
Pharmacokinetics of SC-003: Vss (volume of distribution at steady state)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Evanston, Illinois, United States
Unnamed facility
Boston, Massachusetts, United States
Unnamed facility
Detroit, Michigan, United States
Unnamed facility
Detroit, Michigan, United States
Unnamed facility
Rochester, Minnesota, United States
Unnamed facility
St Louis, Missouri, United States
Unnamed facility
New York, New York, United States
...and 6 more locations
Time frame: Cycle 1 and 4: days 1 (pre-dose, post-dose: 30min, 6hr), 2, 4, 8, 15; Cycles 2, 3, and 5: day 1 (pre-dose, post-dose: 30min