A Multicenter, Phase 1/1b, Open-Label, Dose-Escalation Study of ABT-165, a Dual Variable Domain Immunoglobulin in Subjects With Advanced Solid Tumors

Trial ID #	NCT01946074
Phase	I
Drug Class	Angiogenesis Inhibitors: VEGF/DLL4
Drug Name	Dilpacimab
Alternate Drug Names	ABT-165, dual variable domain immunoglobulin ABT-165, DVD-Ig ABT-165
Drugs in Trial	Dilpacimab
Eligible Participant	Advanced solid tumors
Patients Enrolled	55 patients; median 4 prior therapies (1-10), 17 ovarian
Therapy Setting	Recurrence
Study Design	Open-Label, Non-randomized
Endpoints	ORR, evaluated per RECIST
Efficacy	ORR: 25% (4PR, n=16)
Clinically Significant Adverse Events	Serious AE: 2 pt w/ gastrointestinal perforation Grade 3-4 AE: any (85.5%), hypertension (38.2%)
Conclusion	Dilpacimab (ABT-165) monotherapy is well tolerated and demonstrates anti-tumor activity in refractory ovarian cancer with anti-VEGF-like toxicities (hypertension, gastrointestinal perforation)
Reference	Gordon MS et al. Phase 1 open-label study evaluating the safety, pharmacokinetics, and preliminary efficacy of dilpacimab in patients with advanced solid tumors. Mol Cancer Ther (2021) 20(10):1988-1995 https://pubmed.ncbi.nlm.nih.gov/34315767/