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/

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