Summit Therapeutics Announces Opening of Global Phase II Study of Ivonescimab-Based Regimens in Advanced Clear Cell Renal Cell Carcinoma
SMT112-216 Is a Randomized Multiregional Phase II Study Evaluating Ivonescimab Alone and in Combination with Cadonilimab or Ipilimumab in Previously Untreated Advanced ccRCC
Study Is Being Conducted in Collaboration with Summit's Partner Akeso, with Clinical Trial Sites in the U.S. and China
MIAMI, October 19, 2026--Summit Therapeutics Inc. (NASDAQ: SMMT) today announced the initiation and opening of clinical trial sites of a multiregional Phase II study of ivonescimab, a novel, potential first-in-class investigational PD-1 / VEGF bispecific antibody, in previously untreated advanced clear cell renal cell carcinoma (ccRCC), the most common form of kidney cancer. The study (SMT112-216 / AK112-216 / NCT07877194) is being conducted in collaboration with Summit's partner, Akeso Inc.
SMT112-216 is a randomized, open-label Phase II clinical study designed to evaluate the safety and efficacy of multiple ivonescimab-based treatment approaches in patients with incurable locally advanced or metastatic ccRCC who have not received prior systemic therapy for advanced disease. The study plans to enroll approximately 100 patients at clinical trial sites in the U.S. and China. Participants will be randomized to receive ivonescimab in combination with cadonilimab, ivonescimab in combination with ipilimumab, ivonescimab monotherapy, or nivolumab plus ipilimumab as an established standard-of-care comparator regimen. Cadonilimab is an investigational PD-1 / CTLA-4 bispecific antibody developed by Akeso. This study is in addition to Summit's clinical trial collaboration with Arcus Biosciences evaluating ivonescimab in combination with casdatifan, a HIF2α inhibitor, in a similar ccRCC setting.
"In collaboration with Akeso, SMT112-216 reflects an important part of our shared strategy to evaluate ivonescimab across multiple treatment approaches, including combination regimens, in tumor types where meaningful unmet needs remain," said Robert W. Duggan, Chairman and Co-Chief Executive Officer of Summit Therapeutics. "As we continue to build a broad development program beyond lung, SMT112-216 adds to a growing body of studies in genitourinary and other malignancies that support our strategy to advance ivonescimab where there is strong scientific rationale."
"Ivonescimab's dual targeting of PD-1 and VEGF is especially relevant in renal cell carcinoma, where both pathways have been shown to be valid targets to impact the course of the disease," said Dr. Maky Zanganeh, President and Co-Chief Executive Officer of Summit Therapeutics. "Evaluating multiple ivonescimab-based regimens in the treatment-naïve incurable setting gives us the opportunity to assess ivonescimab's dual mechanism early in the treatment journey, where immune-based combinations are well established and a differentiated immuno-oncology approach could be meaningful for patients."