Global Ph 2 Study of Ivonescimab in 1L Clear Cell RCC, Including Combination with Cadonilimab, initiated

Akeso, Inc. and its partner Summit Therapeutics Inc. jointly announced an international multicenter Phase II clinical study (SMT112-216 / AK112-216 / NCT07877194). Built on Akeso’s first-in-class immuno-oncology (IO) cornerstone therapy ivonescimab (PD-1/VEGF bispecific antibody), the study will assess the efficacy and safety of multiple treatment regimens, including the combination of ivonescimab with Akeso’s first-in-class bispecific antibody cadonilimab (PD-1/CTLA-4 bispecific antibody), in previously untreated patients with advanced clear cell renal cell carcinoma (ccRCC), the most common type of kidney cancer. Participants will be randomized to receive ivonescimab in combination with cadonilimab, ivonescimab in combination with ipilimumab, ivonescimab monotherapy, or the established international standard-of-care comparator regimen of nivolumab plus ipilimumab.

Share:

More News

“The positive outcome of our pre-IND interactions with the FDA reinforces the development pathway for MaaT034 and supports its continued advancement toward the clinic. It also represents an important step in MaaT Pharma’s expansion into immuno-oncology, highlighting the broader potential of our first in class co-cultivated microbiome donor-independent platform across

“Patients with metastatic RAS G12D non-squamous NSCLC, occurring in approximately 4% of cases, represent an underserved population, with no approved targeted treatment options. Initial clinical data evaluating zoldonrasib in combination with standard of care pembrolizumab and platinum doublet chemotherapy in patients with previously untreated metastatic RAS G12D non-squamous NSCLC showed

“At Georgiamune, we are focused on uncovering novel mechanisms that control immune-cell function and translating that biology into first-in-class medicines across autoimmune disease and oncology,” said Samir N. Khleif, M.D., Founder and Chief Executive Officer of Georgiamune. “GIM-621 is one of multiple programs to emerge from that work, alongside three

“Our team’s outstanding execution has enabled us to rapidly advance three programs into the clinic in 2026 and make significant progress in developing next-generation IO, ADC and combination therapies. Together with our partner, Kelun-Biotech, we have achieved seven IND clearances to date, and by mid-2027, we expect more than 2,000