Clinical trials are evolving as sponsors and regulators seek faster, safer pathways to new therapies. Persistent challenges — lengthy recruitment, low retention, high costs and limited diversity — have prompted a rethinking of trial design, with oncology emerging as a leading area of innovation through early regulatory engagement and complex adaptive approaches.
MEDSIR, founded in 2012, has developed an end-to-end model for strategic oncology trials, translating clinicians’ concepts into robust studies. The company’s recent programs — DEMETHER, CADILLAC and THERANOVA — illustrate a focus on patient-centered, operationally efficient and scientifically rigorous designs.
DEMETHER evaluates a novel sequencing strategy for HER2-positive advanced breast cancer. Traditionally, first-line treatment combines chemotherapy with pertuzumab and trastuzumab followed by antibody maintenance, with trastuzumab deruxtecan (T-DXd) used at progression. DEMETHER (NCT06172127), funded by Roche and launched in mid-2024 across Europe, the United States and Brazil, tests T-DXd as an induction therapy followed by maintenance with a fixed-dose pertuzumab–trastuzumab combination (PHESGO). The trial aims to preserve T-DXd’s potent antitumor activity while improving long-term tolerability and convenience versus current approaches, building on the established CLEOPATRA standard and recent data showing benefit for T-DXd combinations.
CADILLAC targets hormone receptor–positive, HER2-negative advanced breast cancer, where first-line endocrine therapy plus CDK4/6 inhibitors has improved outcomes but resistance remains common. The study pairs camizestrant, a selective estrogen receptor degrader, with ribociclib and uses an external control arm drawn from an existing database of patients treated with standard-of-care endocrine therapy plus ribociclib. Funded by AstraZeneca (providing camizestrant) and Novartis (providing ribociclib), the design reduces the number of patients randomized to control therapy, accelerates timelines and lowers operational burden while focusing evaluation on the experimental regimen.
THERANOVA develops a platform for theranostics — combining targeted diagnostic imaging with radiopharmaceutical therapy. The study, funded by Novartis, begins with a diagnostic phase to confirm target expression in a small patient cohort using SPECT/PET agents, then moves to a therapeutic phase using matched radiopharmaceuticals that deliver localized radiation to the same target. Each phase is reviewed by a multidisciplinary committee to assess safety and efficacy before progression. The platform aims to streamline evaluation of multiple radiopharmaceuticals across tumor types and generate data to guide precision use of these agents.
These initiatives reflect broader trends in clinical research: adaptive trial formats, external controls and integrated diagnostic-therapeutic platforms intended to improve patient outcomes and increase development efficiency. MEDSIR’s recent trials emphasize balancing innovation with patient safety and operational practicality as oncology trials adapt to new scientific and regulatory expectations.
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