Clinical trials are evolving to accelerate access to safer, more effective therapies and to overcome long recruitment timelines, low retention, high costs and limited diversity in study populations. Regulatory and industry stakeholders have highlighted complex innovative trial designs as a path to deliver medicines more efficiently, with oncology emerging as a leading area of innovation.
MEDSIR, founded in 2012 by scientific experts, has developed an end-to-end model for managing strategic oncology trials from study design to publication. The company is now advancing a portfolio of novel trials that blend approved and experimental agents, adaptive methods and platform approaches to prioritize patient benefit and operational efficiency.
The DEMETHER trial (NCT06172127), funded by Roche, is an international, multicenter, open-label study testing trastuzumab deruxtecan (T-DXd) as initial therapy followed by maintenance with a fixed-dose combination of pertuzumab and trastuzumab (PHESGO) in patients with HER2-positive advanced breast cancer. Enrollment began in mid-2024 across Europe, the United States and Brazil. The study aims to combine the potent antitumor activity of T-DXd with the long-term tolerability and convenience of PHESGO maintenance, seeking an effective and better-tolerated first-line option informed by recent data showing benefit for regimens that include T-DXd and pertuzumab.
The CADILLAC study focuses on hormone receptor–positive, HER2-negative advanced breast cancer, where first-line endocrine therapy plus CDK4/6 inhibition has improved outcomes but resistance remains common. CADILLAC will evaluate camizestrant, a novel selective estrogen receptor degrader, combined with the CDK4/6 inhibitor ribociclib. Rather than using a conventional randomized control arm, the trial will enroll about 150 patients on the experimental regimen and compare outcomes with an external control group drawn from existing databases of patients treated with standard endocrine therapy plus ribociclib. Funded by AstraZeneca and Novartis, the design aims to reduce exposure of patients to potentially less effective therapies, speed trial timelines and improve cost efficiency while maintaining a robust comparative framework.
THERANOVA establishes a platform for theranostics, an integrated diagnostic and therapeutic approach using radiopharmaceuticals that enable molecular imaging and targeted radiation delivery. Funded by Novartis, the study begins with a diagnostic phase to confirm target expression by SPECT/PET in a small patient cohort; if confirmed, a therapeutic phase follows using a matching radiopharmaceutical to deliver localized radiation. Each phase will be reviewed by a multidisciplinary committee to assess safety and efficacy before progression. The platform is intended to generate systematic data across tumor types and support rapid evaluation of novel radiopharmaceuticals, building on clinical advances in neuroendocrine and prostate cancers.
Together, CADILLAC, DEMETHER and THERANOVA illustrate MEDSIR’s emphasis on patient-centered, scientifically rigorous trial designs that incorporate adaptive methods, external controls and platform strategies. These approaches aim to shorten development timelines, improve the relevance of evidence and expand treatment options for patients with cancer.
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