A Phase 1b Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of Sitravatinib in Combination With Tislelizumab in Patients With Advanced Solid Tumors

Trial ID #	NCT03666143
Phase	I
Drug Class	Angiogenesis Inhibitors: Multi-targeted RTK
Drug Name	Sitravatinib
Alternate Drug Names	MGCD516, multitargeted kinase inhibitor MGCD516
Drugs in Trial	Sitravatinib, Tislelizumab
Eligible Participant	Platinum resistant ovarian cancer, no prior checkpoint inhibitor
Patients Enrolled	60; median 4 prior therapies (1-11); 35% w/ prior bevacizumab
Therapy Setting	Recurrence
Study Design	Open-Label, Non-randomized
Endpoints	ORR, DCR, DoR, PFS, OS, evaluated per RECIST
Efficacy	ORR: 26% (14PR, n=53) DCR: 77% (14PR, 27SD, n=53) DoR: 4.7 months PFS: 4.1 months OS: 12.9 months
Clinically Significant Adverse Events	Serious AE: Grade 3-4 AE: hypertension (18%), abdominal pain (12%), fatigue (10%), increased transaminases (10%)
Conclusion	Combination treatment with sitravatinib and tislelizumab is manageable and shows promising antitumor activity
Reference	Goh J et al. Safety/tolerability and preliminary antitumor activity of sitravatinib plus tislelizumab in patients with advanced platinum-resistant ovarian cancer (PROC). AACR (2021) abstract CT013 and presentation https://www.clearityfoundation.org/wp-content/uploads/2021/04/SitravatinibTislelizumab-Goh-Abtract-CT013-AACR-2021.pdf