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

Trial ID #	NCT02146313
Phase	I
Drug Class	Antibody Drug Conjugates: MUC16 (CA125)
Drug Name	DMUC4064A
Drugs in Trial	DMUC4064A
Eligible Participant	Platinum resistant ovarian cancer
Patients Enrolled	65
Therapy Setting	Recurrence
Study Design	Open-Label, Non-randomized
Endpoints	CBR, ORR, PFS, RP2D, evaluated per RECIST
Biomarkers	CA125, MUC16 protein
Efficacy	RP2D: 5.2mg/kg ORR: 24.6% (16 CR/PR, n=65) CBR: 42% PFS: 3.9 months
Clinically Significant Adverse Events	Dose Limiting Toxicities: at 5.2 mg/kg: grade 3 colitis, hyperglycemia, and hypokalemia (n=1); at 5.6 mg/kg: grade 5 septic shock (n=1) Serious AE: none Grade 3-4 AE: overall (25%), hyponatremia (11%), keratitis (10%)
Conclusion	Anti-tumor activity with acceptable safety profile
Reference	Liu J et al. An open-label phase I dose-escalation study of the safety and pharmacokinetics of DMUC4064A in patients with platinum-resistant ovarian cancer. Gynecol Oncol (2021) 163(3):473-480 https://pubmed.ncbi.nlm.nih.gov/34627611/