Biopharmaceutical company Akeso announced on Wednesday, October 21, 2026, that its global partner Summit Therapeutics has entered a formal clinical trial collaboration with the ECOG-ACRIN Cancer Research Group. According to The Manila Times, the partnership will conduct a registration-enabling Phase II/III study evaluating the investigational drug ivonescimab as a first-line treatment for patients diagnosed with advanced biliary tract cancer.
The newly established trial, designated as EA2251 and registered under clinical trial identifier NCT07765433, is scheduled to begin activating clinical trial sites across the United States in the fourth quarter of 2026. Researchers will examine whether combining ivonescimab with standard chemotherapy offers improved outcomes and safety compared to existing front-line immunotherapy treatments.
Inside the EA2251 Trial Design
Biliary tract cancer is a rare and aggressive malignancy that affects the bile ducts and gallbladder. Because early symptoms are often subtle or absent, patients frequently receive a diagnosis only after the disease has reached an advanced stage, limiting surgical options and creating an urgent need for effective systemic therapies.
In the EA2251 study, investigators will directly compare the safety and efficacy of ivonescimab paired with chemotherapy against the current standard of care, which consists of either pembrolizumab or durvalumab combined with chemotherapy. Both pembrolizumab and durvalumab are established checkpoint inhibitors currently used as initial treatments for advanced biliary tract tumors.
Deirdre J. Cohen, MD, MS, will serve as the lead investigator for the trial. Dr. Cohen is an Associate Professor of Medicine at the Icahn School of Medicine at Mount Sinai, where she also serves as Director of the Gastrointestinal Oncology Program for the Mount Sinai Health System and Co-Director of the Center of Excellence for Pancreatic Cancer at the Mount Sinai Tisch Cancer Center. She noted that despite recent treatment advances, patients with advanced biliary tract cancer still require more effective initial options that can prolong survival and better control disease progression. According to Dr. Cohen, the EA2251 study will test a new therapeutic approach in the front-line setting by measuring ivonescimab and chemotherapy directly against established immunotherapy standards.
The trial is sponsored and conducted in partnership with ECOG-ACRIN, a major scientific organization focused on multicenter cancer trials in adults. The group's research network spans more than 1,400 hospitals and cancer centers across the United States and internationally, incorporating nearly 21,000 oncology specialists, research professionals, and patient advocates.
Building on Previous Clinical Results
The launch of the United States-based trial follows encouraging data from an earlier late-stage study conducted in China. EA2251 represents the second Phase III registrational study of ivonescimab specifically targeting biliary tract cancer, and the seventh international registrational Phase II/III trial for the medication overall.
Previously, Akeso conducted the Phase III HARMONi-GI1 study—also known as AK112-309—in China. That trial evaluated ivonescimab plus chemotherapy against durvalumab plus chemotherapy as an initial treatment for patients with biliary tract cancer. According to the announcement published via The Manila Times, the HARMONi-GI1 study met its primary goal, demonstrating a positive overall survival result that was both statistically significant and clinically meaningful for patients.
Detailed clinical findings from the HARMONi-GI1 study are scheduled to be presented to the medical community at the European Society for Medical Oncology 2026 Congress (ESMO 2026) on Sunday, October 25, 2026. The presentation will take place during the conference's Presidential Symposium from 11:30 a.m. to 1:15 p.m. EDT (4:30 p.m. to 6:15 p.m. CET).
Dr. Michelle Xia, Founder, Chairwoman, President, and Chief Executive Officer of Akeso, stated that the positive survival results from the HARMONi-GI1 trial laid the groundwork for expanding global clinical development. She added that advancing the EA2251 study alongside a prominent United States cooperative oncology group reinforces confidence in the drug's global potential to become a treatment option for biliary tract cancer patients worldwide.
Dr. Maky Zanganeh, President and Co-Chief Executive Officer of Summit Therapeutics, also emphasized the significance of the collaboration. Dr. Zanganeh noted that having ECOG-ACRIN sponsor and conduct the registration-enabling trial highlights the scientific community's interest in testing ivonescimab against difficult-to-treat malignancies while supporting Summit's efforts to build clinical evidence across varied tumor types.
How Ivonescimab Works and Its Global Reach
Ivonescimab is an investigational, first-in-class bispecific antibody independently developed by Akeso. Unlike traditional monoclonal antibodies that target a single biological pathway, ivonescimab is engineered to target two distinct mechanisms simultaneously within a single molecule: programmed cell death protein 1 (PD-1) and vascular endothelial growth factor (VEGF).
By combining these two functions, the therapy merges immuno-oncology—which helps the body's immune system recognize and attack cancer cells via PD-1 inhibition—with anti-angiogenesis, which restricts the blood supply that tumors need to grow by blocking VEGF. Ivonescimab is the first approved bispecific antibody globally to integrate both of these mechanisms into one single-molecule therapy, and it previously became the first drug to demonstrate positive results in a Phase III head-to-head trial against pembrolizumab.
Beyond biliary tract cancer, the medication is currently being tested in more than 18 Phase III clinical trials worldwide. This broad research program includes seven international multi-regional registrational Phase III trials and seven direct head-to-head comparisons against existing PD-1 or PD-L1 immunotherapies. Active research encompasses eight registrational or Phase III studies in lung cancer, alongside first-line trials in colorectal cancer, head and neck squamous cell carcinoma, triple-negative breast cancer, pancreatic cancer, and urothelial carcinoma.
While Akeso—founded in 2012—maintains a pipeline of more than 50 biological assets andnearly 30 clinical-stage candidates, the company out-licensed exclusive rights to develop and commercialize ivonescimab in several major territories to Summit Therapeutics. Under that licensing agreement, which carries a total potential value of up to $5 billion, Summit Therapeutics holds exclusive rights to the medication across the United States, Canada, South America, Europe, the Middle East, Africa, and Japan.
What This Means for Patients and Caregivers
For individuals diagnosed with advanced biliary tract cancer and their families, the initiation of the EA2251 trial represents a new avenue of clinical research in the United States. Because registration-enabling Phase II/III trials are designed to gather the rigorous safety and efficacy data required by regulatory agencies like the U.S. Food and Drug Administration, successful outcomes could eventually lead to new approved front-line therapies.
With United States clinical site activations expected to commence during the fourth quarter of 2026, patients seeking clinical trial opportunities can discuss the EA2251 study (NCT07765433) with their medical oncologists to determine eligibility and availability at participating ECOG-ACRIN member hospitals.
