Clinical trials are evolving to speed access to safer, more effective therapies, but traditional methods still face obstacles such as slow recruitment, poor retention, high costs and limited population diversity. These challenges have prompted new approaches to trial design, with oncology emerging as a leading area of innovation through early regulatory engagement and complex adaptive designs.
MEDSIR, founded in 2012, has developed an end-to-end model for managing strategic oncology trials, turning clinicians’ ideas into rigorous studies that aim to reshape drug development. The company’s recent programs — DEMETHER, CADILLAC and THERANOVA — illustrate its focus on patient-centered, scientifically robust and operationally efficient trial designs.
DEMETHER evaluates a new sequence for HER2-positive advanced breast cancer. The international, multicenter, open-label study (NCT06172127), funded by Roche, tests trastuzumab deruxtecan (T-DXd) as induction therapy followed by maintenance with the fixed-dose pertuzumab–trastuzumab combination PHESGO. Enrollment began in mid‑2024 across Europe, the United States and Brazil. The trial seeks to combine the potent antitumor activity of T-DXd with the long-term tolerability and convenience of PHESGO, potentially redefining first-line treatment while minimizing cumulative toxicity and preserving quality of life. The design builds on recent data showing improved progression-free survival with T-DXd combined with pertuzumab.
CADILLAC explores a different innovation: using an external control arm to evaluate camizestrant, a selective estrogen receptor degrader, combined with the CDK4/6 inhibitor ribociclib in hormone receptor–positive, HER2‑negative advanced breast cancer. The study will enroll about 150 patients on the experimental regimen and compare outcomes with a control cohort drawn from an existing database of patients treated with standard endocrine therapy plus ribociclib. Funded by AstraZeneca (camizestrant) and Novartis (ribociclib), the design aims to reduce the number of patients randomized to less effective therapies, accelerate timelines and improve cost-efficiency while focusing resources on assessing the investigational combination.
THERANOVA establishes a theranostics platform that integrates diagnostic imaging and targeted radiotherapy. Funded by Novartis, the study uses two radiopharmaceuticals: one to image target expression and a second to deliver localized therapeutic radiation to the same target. An initial diagnostic phase will screen a small cohort to confirm target suitability; patients with confirmed targets may then proceed to the therapeutic phase. A multidisciplinary committee will evaluate safety and efficacy after each phase. The approach builds on clinical successes in neuroendocrine and prostate cancers and aims to generate a flexible platform for testing radiopharmaceuticals across tumor types.
These trials reflect broader shifts in clinical research toward adaptive designs, external controls and precision-targeted therapies. By combining innovative scientific strategies with operational efficiencies and patient-centered safeguards, MEDSIR’s programs seek to accelerate development and deliver meaningful treatment options to patients with cancer.
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