The FDA has granted fast track designation to cesalatamig (AI-081), an investigational PD-1/VEGF bispecific antibody, for the treatment of patients with non–small cell lung cancer (NSCLC) whose disease has progressed following concurrent or sequential PD-(L)1–targeted immunotherapy and platinum-based chemotherapy, according to a news release from the developer, OncoC4.¹
The agent is currently being evaluated in the global phase 1/2 BiPAVE-001 trials in the US (NCT06635785) and China (CTR20253261).
Why did cesalatamig receive fast track designation?
The designation is intended to support expedited development of cesalatamig for patients with NSCLC that has progressed after PD-(L)1–targeted immunotherapy and platinum-based chemotherapy, a setting with limited treatment options.
“This designation reflects the clinical safety and efficacy signals we have seen in our global phase 1/2 trials, BiPAVE-001 US and BiPAVE-001 China,” said Yang Liu, PhD, cofounder, chief executive officer, and chief scientific officer of OncoC4, in the news release.¹ “We are rapidly advancing to registrational phase 3 development in PD-(L)1–refractory or resistant NSCLC and other indications.”
What is the BiPAVE-001 trial design?
The global BiPAVE-001 phase 1/2 trials are designed to evaluate the safety, efficacy, and pharmacokinetics of cesalatamig in patients with advanced cancer. Part A is a phase 1 dose-escalation and dose-expansion study, and Part B comprises phase 2 dose-optimization studies with multiple cohorts assessing the safety and clinical activity of cesalatamig as monotherapy or in combination with standard-of-care or novel agents. The trials are being conducted at more than 50 clinical sites across the US and China, with the majority of patients enrolled in the US.
The study’s primary end points include the maximum tolerated dose and dose-limiting toxicities.2 Secondary end points include the highest serum concentration of cesalatamig after intravenous infusion and the agent’s serum half-life.
Patients 18 years and older with histologically or cytologically confirmed solid tumors and metastatic or locally advanced disease, an ECOG performance status of 0 or 1, and measurable disease per RECIST v1.1 guidelines are eligible for enrollment on the trial. Having adequate organ function is another requirement for study entry.
Those with brain metastases or leptomeningeal metastases, a history of grade 3 or higher allergies or hypersensitivity to intravenously administered medications, acute infections requiring systemic treatment within 2 weeks of beginning study treatment are ineligible for enrollment. Patients are also ineligible if they have clinically symptomatic pleural effusion, pericardial effusion, or ascites requiring frequent drainage.
What is cesalatamig and how does it work?
Cesalatamig is a differentiated PD-1/VEGF bispecific antibody with high affinity for PD-1 and more than 40-fold higher affinity for VEGF than bevacizumab (Avastin)-based bispecific PD-(L)1/VEGF inhibitors. According to developers, this profile gives the agent best-in-class potential through a stronger cooperative interaction favoring its activity in a PD-1– and VEGF-rich tumor microenvironment. Cesalatamig also incorporates Fc-silencing modifications designed to avoid the depletion of PD-1–positive effector T cells. The agent is wholly owned by OncoC4 and is undergoing global clinical development across multiple oncology indications.
What is fast track designation?
Fast track is an FDA process designed to facilitate the development and expedite the review of therapies that treat serious conditions and address an unmet medical need. A drug that receives the designation may be eligible for more frequent interactions with the FDA, as well as accelerated approval, priority review, and rolling review if relevant criteria are met.
OncoC4, a late clinical-stage biopharmaceutical company based in Rockville, Maryland, stated that it is advancing cesalatamig toward registrational phase 3 development in PD-(L)1–refractory or resistant NSCLC and other indications.
References
- OncoC4 receives FDA fast track designation for cesalatamig, an investigational PD-1/VEGF bispecific antibody. News release. OncoC4 Inc. September 16, 2026. Accessed September 17, 2026. https://tinyurl.com/3x66zm6a
- Safety, pharmacokinetics, and efficacy of AI-081, a bispecific antibody for PD-1 And VEGF in advanced solid tumors (BiPAVE-001). ClinicalTrials.gov. Updated August 17, 2026. Accessed September 17, 2026. https://tinyurl.com/y937h7r3
