Immuno-oncology

Constructed differentiation strategies (versus SOC and mAbs in development such as Pembrolizumab (Keytruda) and Ivonescimab) for next generation of PD-1 x VEGF bispecific antibody incorporating the cooperative binding mechanism targeting solid tumors using Master Protocol (Platform Trial) design from FIH to Phase 3.

• Designed single, overarching trial infrastructure designed to evaluate PD-1 x VEGF across multiple cancer types (sub-protocols) concurrently. Authored master protocol to define shared elements (safety monitoring, PK/PD, master ICF template). In parallel constructed sub-protocols for indication-specific sub studies (RCC, NSCLC, CRC) detailed eligibility, endpoints, specific schedules.
• Utilized optimal biological dose (OBD) approach to identify indication-specific Recommended Phase 2 Dose (RP2D) including induction through maintenance phases
• Compiled SAP incorporated Bayesian Adaptive Designs (BOIN2 / BOP2) statistical framework using accumulating trial data to enable timely decisions about the dose for the next Participant or cohort. Adaptive design with decision rules enabled understanding of dose-toxicity/efficacy probabilities as new Participant data comes in.
• Advanced wnt/beta-catenin pathway bi-specific and tri-specific monoclonal antibodies for hepatic carcinomas.
• Authored clinical trials protocols for Annexin targeted cancers targeting pulmonary, breast and colorectal tumors.
• Led immune-histological assay designs for tumor margin assessments