DMUC4064A
DrugParticipants will receive escalated DMUC4064A dose or RP2D, as a single agent by intravenous (IV) infusion q3w on Day 1 of each cycle (21 days).
NCT Number: NCT02146313
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 1
Florida Cancer Specialists - Sarasota (North Catttlemen Rd), Sarasota, Florida, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
For ovarian cancer dose expansion cohorts only:
Participants with Pancreatic Cancer:
Exclusion criteria
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).
Time frame: Day 1 up to Day 21 of Cycle 1 (Cycle length[CL]= 21 days)
Time frame: Day 1 up to Day 21 of Cycle 1 (CL=21 days)
Time frame: Baseline up to safety-follow up (approximately 3.5 years)
Time frame: Baseline up to safety-follow up (approximately 3.5 years)
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)
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)
Time frame: At baseline and even numbered cycles and at study termination (approximately 3.5 years) (CL=21 days)
Time frame: At baseline and even numbered cycles and at study termination (approximately 3.5 years) (CL=21 days)
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)
Genentech, Inc.
Industry
A Phase I, Open-Label, Dose-Escalation Study of the Safety, Tolerability, and Pharmacokinetics of DMUC4064A Administered Intravenously to Patients With Platinum-Resistant Ovarian Cancer or Unresectable Pancreatic Cancer
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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