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 Tislelizumab, Sitravatinib
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

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