Clinical trials are undergoing rapid change as researchers seek faster access to safer, more effective therapies. Traditional trial methods still face long recruitment times, low retention, high costs and limited diversity among participants, prompting renewed efforts to redesign how studies are planned and run. Oncology has emerged as a key driver of these innovations, with early regulatory engagement helping to advance complex trial designs.
MEDSIR, founded in 2012 by scientific experts, has developed a model for managing strategic oncology trials from study design through publication. The company has expanded its portfolio with disruptive, patient-centered trials that integrate novel approaches to accelerate drug development and improve outcomes.
The DEMETHER trial (NCT06172127), funded by Roche, will test a new first-line strategy for HER2-positive advanced breast cancer. Current standard therapy combines chemotherapy with pertuzumab and trastuzumab followed by antibody maintenance; trastuzumab deruxtecan (T-DXd) is typically reserved for later lines. DEMETHER evaluates T-DXd induction followed by maintenance with the fixed-dose pertuzumab-trastuzumab combination PHESGO, aiming to balance T-DXd’s antitumor activity with the long-term tolerability of antibody maintenance. The international, open-label study began enrolling in mid-2024 across Europe, the United States and Brazil and seeks to preserve efficacy while minimizing cumulative toxicity and improving quality of life.
CADILLAC targets HR-positive, HER2-negative advanced breast cancer, a group that makes up most breast cancer cases and where resistance to first-line endocrine therapy plus CDK4/6 inhibitors remains a challenge. The trial will assess camizestrant, a selective estrogen receptor degrader, combined with ribociclib. Rather than a conventional randomized control, CADILLAC will enroll 150 patients on the experimental regimen and use an external control arm drawn from existing databases of patients treated with the standard regimen (endocrine therapy plus ribociclib). Funded by AstraZeneca with drug support from Novartis, the design aims to reduce the number of patients exposed to potentially less effective treatments and to accelerate timelines while improving operational efficiency.
THERANOVA adopts a theranostic approach that pairs diagnostic imaging with targeted radiotherapeutic delivery. The platform will evaluate radiopharmaceuticals that first image an overexpressed tumor target and then, if target expression is confirmed, deliver localized radiation via a therapeutic agent targeting the same molecule. Novartis funds the program, which begins with a diagnostic phase in a small cohort and proceeds to a therapeutic phase when appropriate. An independent multidisciplinary committee will review safety and efficacy at each phase. The design builds on clinical successes in neuroendocrine and prostate cancer and aims to generate a structured dataset to support broader application of theranostics across tumor types.
These trials illustrate MEDSIR’s strategy of integrating regulatory insight, novel trial formats and patient-focused endpoints to advance oncology development. By combining innovative agents with adaptive and external-control designs, the company aims to shorten development timelines, reduce unnecessary patient exposure to inferior therapies and deliver treatments more efficiently to patients. Results from DEMETHER, CADILLAC and THERANOVA are expected to inform future standards of care and demonstrate the value of complex, patient-centered trial designs.
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