This is a Phase 1, multicenter, open-label, dose-escalation study of DMUC4064A administered by intravenous (IV) infusion every three weeks (q3w) to cancer participants. The study will employ a traditional 3 + 3 dose escalation design to determine the maximum tolerated dose (MTD) of DMUC4064A against platinum-resistant ovarian cancer. Once a q3w recommended Phase 2 dose (RP2D) is identified, two expansion cohorts (one in platinum-resistant ovarian cancer and another in unresectable pancreatic cancer) may be evaluated to further characterize the safety and activity in these populations.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Participants will receive escalated DMUC4064A dose or RP2D, as a single agent by intravenous (IV) infusion q3w on Day 1 of each cycle (21 days).
Florida Cancer Specialists - Sarasota (North Catttlemen Rd)
Sarasota, Florida, United States
Massachusetts General Hospital.
Boston, Massachusetts, United States
Dana Farber Cancer Inst.
Boston, Massachusetts, United States
Hackensack Univ Med Ctr
Hackensack, New Jersey, United States
Oklahoma University Health Sciences Center
Oklahoma City, Oklahoma, United States
Sarah Cannon Research Inst.
Nashville, Tennessee, United States
University of Wisconsin
Madison, Wisconsin, United States
Percentage of Participants with Dose-Limiting Toxicities (DLTs)
Time frame: Day 1 up to Day 21 of Cycle 1 (Cycle length[CL]= 21 days)
Maximum Tolerated Dose of DMUC4064A
Time frame: Day 1 up to Day 21 of Cycle 1 (CL=21 days)
Recommended Part II Dose of DMUC4064A
Time frame: Baseline up to safety-follow up (approximately 3.5 years)
Percentage of Participants with Adverse Events (AEs) or Serious Adverse Events (SAEs)
Time frame: Baseline up to safety-follow up (approximately 3.5 years)
Percentage of Participants with Anti-DMUC4064A Antibodies
Time frame: Pre-dose (0 hour[H];post infusion (infusion=90 minutes for C1; 30 minutes for C2 and beyond) on Day 1 of Cycle (C) 1-4; at study completion or early termination (approximately 3.5 years (CL=21 days)
Pharmacokinetic (PK) Profile of DMUC4064A in Participants With Platinum-Resistant Ovarian Cancer or Unresectable Pancreatic Cancer
Time frame: Days 1,2,4,8,11,15 of C1;Days 8,15 of C2-4; at study completion or early termination (approximately 3.5 years)
Percentage of Participants With Objective Response as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Time frame: At baseline and even numbered cycles and at study termination (approximately 3.5 years) (CL=21 days)
Duration of Objective Response
Time frame: At baseline and even numbered cycles and at study termination (approximately 3.5 years) (CL=21 days)
Progression-free Survival (PFS) as Assessed by RECIST v1.1
Time frame: Day 1 of C1 until disease progression or death within 30 days of the last study drug administration, whichever occurs first (approximately 3.5 years) (CL=21 days)
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