A Phase 1a/1b, Multicenter, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK112 in Subjects With Advanced Solid Tumors

Trial ID #	NCT04047290
Phase	Ia/Ib
Drug Class	Immunotherapy: Bispecifics/PD-1, VEGF
Drug Name	Ivonescimab
Alternate Drug Names	anti-PD-1/VEGF bispecific antibody AK112, AK112
Drugs in Trial	Ivonescimab
Eligible Participant	Platinum resistant or refractory ovarian cancer
Patients Enrolled	19 median 3 prior therapies; 13 HGSOC, 3 OCCC, 1 MOC, 1 serous, 1 adenocarcinoma; 6 Pt-Rf; 37% w/ prior bevacizumab
Therapy Setting	Recurrence
Study Design	Open-Label, Non-randomized
Endpoints	ORR, DCR, evaluated per RECIST
Efficacy	ORR: 26.3% (5PR, 3 HGSOC, 2 OCCC) DCR: 78.9% (5PR, 10 SD - 4 HGSOC w/ prior bev had SD for 12+ months)
Clinically Significant Adverse Events	Serious AE: Grade 3-4 AE: Overall (27.5%), hypertension (13/7%)
Reference	Frentzas S et al. Phase 1a dose escalation study of ivonescimab (AK112/SMT112), an anti-PD-1/VEGF-A bispecific antibody, in patients with advanced solid tumors. J Immunother Cancer (2024) 12(4):e008037 https://pubmed.ncbi.nlm.nih.gov/38642937/